OSTEOPAL® V
Heraeus Medical GmbH
Heraeus Medical GmbH
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3006406161 | 3006406161 | Heraeus Medical GmbH | 1 | N | 2026-01-01 | PHILIPP-REIS-STRASSE 8/13 WEHRHEIM Hesse DE D-61273 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 179162 | 1736309943 | K241674 | OSTEOPAL® V | LOD | 2024-12-05 |
| 179162 | 1898073753 | K234028 | COPAL® exchange G hip spacer; COPAL® G+V | KWL | 2024-02-15 |
| 179162 | 1688540951 | K220492 | COPAL exchange G hip spacer | KWY | 2022-03-23 |
| 179162 | 1216256523 | K213812 | PALACOS MV pro | LOD | 2022-02-02 |
| 179162 | 1549349151 | K210607 | PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro | LOD | 2021-07-09 |
| 179162 | 1437353219 | K202475 | PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G | LOD | 2020-11-23 |
| 179162 | 1881150784 | K191016 | COPAL exchange G Hip and Knee Spacers | KWY | 2019-11-01 |
| 179162 | 1997546259 | K190766 | PALACOS fast R+G | LOD | 2019-05-31 |
| 179162 | 1590004918 | K182260 | PALACOS MV | LOD | 2018-09-17 |
| 179162 | 1921597341 | K153737 | OSTEOPAL plus | LOD | 2016-04-22 |
| 179162 | 1153754854 | K150119 | PALACOS R pro | LOD | 2015-06-17 |
| 179162 | 1138719563 | K142157 | PALACOS R+G PRO | LOD | 2014-09-05 |
| 179162 | 1851663477 | K050855 | PALAMED G | LOD | 2005-07-07 |
| 179162 | 1128525252 | K050854 | PALACOS LV+G | LOD | 2005-07-07 |
| 179162 | 1844906205 | K050085 | OSTEOPAL V | LOD | 2005-09-14 |
| 179162 | 1940458230 | K031673 | REFOBACIN -PALACOS G | LOD | 2004-05-25 |
| 179162 | 1814808732 | K030904 | PALAMED | LOD | 2003-09-23 |
| 179162 | 1532185121 | K030903 | OSTEOPAL | LOD | 2003-09-23 |
| 179162 | 1107009544 | K030902 | PALACOS R | LOD | 2003-09-23 |
| 179162 | 1982465577 | K022251 | PALABOND | LOD | 2003-02-26 |
| 179162 | 1165556812 | ||||
| 179162 | 1580842194 | ||||
| 179162 | 1641736191 | ||||
| 179162 | 1252743000 |
Product Codes Associated With Registrations#
PMN#
COPAL® exchange G hip spacer; COPAL® G+V
Heraeus Medical GmbH
COPAL knee moulds
Heraeus Medical GmbH
COPAL Exchange G Hip Spacer
Heraeus Medical GmbH
PALACOS MV Pro
Heraeus Medical GmbH
PALACOS R Pro, PALACOS R+G Pro, PALACOS MV+G Pro
Heraeus Medical GmbH
PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G
Heraeus Medical GmbH
COPAL Exchange G Hip And Knee Spacers
Heraeus Medical GmbH
PALACOS Fast R+G
Heraeus Medical GmbH
PALACOS MV
Heraeus Medical GmbH
OSTEOPAL Plus
HERAEUS MEDICAL GMBH
PALACOS R Pro
HERAEUS MEDICAL GMBH
PALACOS R+G PRO
HERAEUS MEDICAL GMBH
GUDID#
COPAL® exchange G - COPAL® exchange G Trials are an accessory device for intra-operative determination of the correct size of the COPAL® exchange G Spacer. COPAL® exchange G Trials are used for a very short period of time (few minutes) during the first stage of a two-stage exchange septic revision surgery after thorough debridement and are intended for single use. COPAL® exchange G hip and knee Trials resemble the COPAL® exchange G hip and knee Spacers in size, shape and geometry. COPAL® exchange G Trials are easily distin-guishable from COPAL® exchange G Spacers due to their hollow body, their prominent blue color and the stamping “TRIAL - DO NOT IMPLANT”.COPAL® exchange G Trials are available for hip and knee. COPAL® exchange G hip Trials resemble a hemi-endopros-thesis and are available in 8 different sizes. COPAL® exchange G knee Trials consist of a femoral and tibial component and are available in 3 different sizes.COPAL® exchange G Trials do not contain gentamicin.
2020-07-07
COPAL® knee mould Trial M US - COPAL® knee mould Trials are an accessory device for intraoperative determination of the correct size of spacer made from COPAL® knee moulds (Size S: 5159868, Size M: 5159869, Size L: 5159870). COPAL® knee mould Trials are used for a very short period of time (few minutes) during the first stage of a two-stage exchange revision procedure due to a septic process after thorough debridement and are intended for single use. COPAL® knee mould Trials resemble the spacer made from COPAL® knee moulds in size, shape, and geometry. COPAL® knee mould Trials are easily distinguishable from COPAL® knee mould spacers due to their prominent blue color and the stamping “Do not implant”.
2023-06-25
COPAL® knee mould Trial L US - COPAL® knee mould Trials are an accessory device for intraoperative determination of the correct size of spacer made from COPAL® knee moulds (Size S: 5159868, Size M: 5159869, Size L: 5159870). COPAL® knee mould Trials are used for a very short period of time (few minutes) during the first stage of a two-stage exchange revision procedure due to a septic process after thorough debridement and are intended for single use. COPAL® knee mould Trials resemble the spacer made from COPAL® knee moulds in size, shape, and geometry. COPAL® knee mould Trials are easily distinguishable from COPAL® knee mould spacers due to their prominent blue color and the stamping “Do not implant”.
2023-06-25
COPAL® knee mould Trial S US - COPAL® knee mould Trials are an accessory device for intraoperative determination of the correct size of spacer made from COPAL® knee moulds (Size S: 5159868, Size M: 5159869, Size L: 5159870). COPAL® knee mould Trials are used for a very short period of time (few minutes) during the first stage of a two-stage exchange revision procedure due to a septic process after thorough debridement and are intended for single use. COPAL® knee mould Trials resemble the spacer made from COPAL® knee moulds in size, shape, and geometry. COPAL® knee mould Trials are easily distinguishable from COPAL® knee mould spacers due to their prominent blue color and the stamping “Do not implant”.
2023-06-25
OSTEOPAL® - OSTEOPAL® V is a standard-setting, low-viscosity, radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement. It contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141). The bone cement consists of two components and is prepared immediately before use by mixing the polymer powder with the monomer liquid. The low viscosity increases with progressing polymerization. A paste forms that is inserted into the vertebral body using an application system and sets within a few minutes. OSTEOPAL® V is intended for single use and is supplied sterile.
2025-09-26
OSTEOPAL® - OSTEOPAL® V is a standard-setting, low-viscosity, radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement. It contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141). The bone cement consists of two components and is prepared immediately before use by mixing the polymer powder with the monomer liquid. The low viscosity increases with progressing polymerization. A paste forms that is inserted into the vertebral body using an application system and sets within a few minutes. OSTEOPAL® V is intended for single use and is supplied sterile.
2025-09-26
COPAL® G+V - COPAL® G+V is a standard-setting, high-viscosity, radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement and designed for fixation of COPAL® exchange G hip spacer to the host bone.It contains the aminoglycoside antibiotic gentamicin and the glycopeptide antibiotic vancomycin to protect the cured bone cement and surrounding tissue from colonization by bacteria that are sensitive to gentamicin and/or vancomycin. It contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex(E141).The bone cement consists of two components and is prepared immediately before use by mixing the polymer powder with the monomer liquid. COPAL® G+V is intended for single-use and is supplied sterile.
2024-06-10
COPAL® G+V - COPAL® G+V is a standard-setting, high-viscosity, radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement and designed for fixation of COPAL® exchange G hip spacer to the host bone. It contains the aminoglycoside antibiotic gentamicin and the glycopeptide antibiotic vancomycin to protect the cured bone cement and surrounding tissue from colonization by bacteria that are sensitive to gentamicin and/or vancomycin. It contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex(E141). The bone cement consists of two components and is prepared immediately before use by mixing the polymer powder with the monomer liquid. COPAL® G+V is intended for single-use and is supplied sterile.
2024-06-10
COPAL® exchange G - COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile.COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. It contains the X-ray contrast medium calcium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).
2019-11-25
COPAL® exchange G - COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile.COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. It contains the X-ray contrast medium calcium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).
2019-11-25
COPAL® exchange G - COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile.COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. It contains the X-ray contrast medium calcium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).
2019-11-25
COPAL® exchange G - COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile.COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. It contains the X-ray contrast medium calcium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).
2019-11-25
COPAL® exchange G - COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile.COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. It contains the X-ray contrast medium calcium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).
2019-11-25
COPAL® exchange G - COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile.COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. It contains the X-ray contrast medium calcium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).
2019-11-25
COPAL® exchange G - COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile.COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. It contains the X-ray contrast medium calcium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).
2019-11-25
COPAL® exchange G - COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile.COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. It contains the X-ray contrast medium calcium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).
2022-05-15
COPAL® exchange G - COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile.COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. It contains the X-ray contrast medium calcium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).
2022-05-15
COPAL® exchange G - COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile.COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. It contains the X-ray contrast medium calcium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).
2019-11-25
COPAL® exchange G - The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage revision procedure for an infected total joint, a temporary implant to l) allow for partial weight bearing and 2) provide an approximate natural range of motion. The devices also maintain a patient's soft tissue and joint space, preventing further complications such as muscular contraction. The gentamicin protects the device from bacterial colonization. The COPAL® exchange G Hip and Knee Spacers are placed into the joint to maintain normal joint space and alignment. They provide patient comfort and limited mobility while the infection is being treated. The COPAL® exchange G Hip and Knee Spacers are made with bone cement that are loaded with gentamicin antibiotics. The COPAL® exchange G Hip and Knee Spacers are temporary joint prostheses designed to temporarily replace an infected implant during a total hip or knee arthroplasty and provide the patient with limited mobility and predictable, consistent local antibiotic release.
2019-11-25
COPAL® exchange G - The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage revision procedure for an infected total joint, a temporary implant to l) allow for partial weight bearing and 2) provide an approximate natural range of motion. The devices also maintain a patient's soft tissue and joint space, preventing further complications such as muscular contraction. The gentamicin protects the device from bacterial colonization. The COPAL® exchange G Hip and Knee Spacers are placed into the joint to maintain normal joint space and alignment. They provide patient comfort and limited mobility while the infection is being treated. The COPAL® exchange G Hip and Knee Spacers are made with bone cement that are loaded with gentamicin antibiotics. The COPAL® exchange G Hip and Knee Spacers are temporary joint prostheses designed to temporarily replace an infected implant during a total hip or knee arthroplasty and provide the patient with limited mobility and predictable, consistent local antibiotic release
2019-11-25
COPAL® exchange G - The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage revision procedure for an infected total joint, a temporary implant to l) allow for partial weight bearing and 2) provide an approximate natural range of motion. The devices also maintain a patient's soft tissue and joint space, preventing further complications such as muscular contraction. The gentamicin protects the device from bacterial colonization. The COPAL® exchange G Hip and Knee Spacers are placed into the joint to maintain normal joint space and alignment. They provide patient comfort and limited mobility while the infection is being treated. The COPAL® exchange G Hip and Knee Spacers are made with bone cement that are loaded with gentamicin antibiotics. The COPAL® exchange G Hip and Knee Spacers are temporary joint prostheses designed to temporarily replace an infected implant during a total hip or knee arthroplasty and provide the patient with limited mobility and predictable, consistent local antibiotic release.
2019-11-25
COPAL® exchange G - The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage revision procedure for an infected total joint, a temporary implant to l) allow for partial weight bearing and 2) provide an approximate natural range of motion. The devices also maintain a patient's soft tissue and joint space, preventing further complications such as muscular contraction. The gentamicin protects the device from bacterial colonization. The COPAL® exchange G Hip and Knee Spacers are placed into the joint to maintain normal joint space and alignment. They provide patient comfort and limited mobility while the infection is being treated. The COPAL® exchange G Hip and Knee Spacers are made with bone cement that are loaded with gentamicin antibiotics. The COPAL® exchange G Hip and Knee Spacers are temporary joint prostheses designed to temporarily replace an infected implant during a total hip or knee arthroplasty and provide the patient with limited mobility and predictable, consistent local antibiotic release.
2019-11-25
COPAL® exchange G - The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage revision procedure for an infected total joint, a temporary implant to l) allow for partial weight bearing and 2) provide an approximate natural range of motion. The devices also maintain a patient's soft tissue and joint space, preventing further complications such as muscular contraction. The gentamicin protects the device from bacterial colonization. The COPAL® exchange G Hip and Knee Spacers are placed into the joint to maintain normal joint space and alignment. They provide patient comfort and limited mobility while the infection is being treated. The COPAL® exchange G Hip and Knee Spacers are made with bone cement that are loaded with gentamicin antibiotics. The COPAL® exchange G Hip and Knee Spacers are temporary joint prostheses designed to temporarily replace an infected implant during a total hip or knee arthroplasty and provide the patient with limited mobility and predictable, consistent local antibiotic release.
2019-11-25
COPAL® exchange G - The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage revision procedure for an infected total joint, a temporary implant to l) allow for partial weight bearing and 2) provide an approximate natural range of motion. The devices also maintain a patient's soft tissue and joint space, preventing further complications such as muscular contraction. The gentamicin protects the device from bacterial colonization. The COPAL® exchange G Hip and Knee Spacers are placed into the joint to maintain normal joint space and alignment. They provide patient comfort and limited mobility while the infection is being treated. The COPAL® exchange G Hip and Knee Spacers are made with bone cement that are loaded with gentamicin antibiotics. The COPAL® exchange G Hip and Knee Spacers are temporary joint prostheses designed to temporarily replace an infected implant during a total hip or knee arthroplasty and provide the patient with limited mobility and predictable, consistent local antibiotic release.
2019-11-25
COPAL® exchange G - The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage revision procedure for an infected total joint, a temporary implant to l) allow for partial weight bearing and 2) provide an approximate natural range of motion. The devices also maintain a patient's soft tissue and joint space, preventing further complications such as muscular contraction. The gentamicin protects the device from bacterial colonization. The COPAL® exchange G Hip and Knee Spacers are placed into the joint to maintain normal joint space and alignment. They provide patient comfort and limited mobility while the infection is being treated. The COPAL® exchange G Hip and Knee Spacers are made with bone cement that are loaded with gentamicin antibiotics. The COPAL® exchange G Hip and Knee Spacers are temporary joint prostheses designed to temporarily replace an infected implant during a total hip or knee arthroplasty and provide the patient with limited mobility and predictable, consistent local antibiotic release.
2019-11-25
PALACOS® - The PALACOS® R+G pro system consists of a mixing and application system prefilled with PALACOS® polymer powder and monomer liquid. PALACOS® R+G pro is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.
2021-07-15
PALACOS® - The PALACOS® R+G pro system consists of a mixing and application system prefilled with PALACOS® polymer powder and monomer liquid. PALACOS® R+G pro is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.
2021-07-15
PALACOS® - The PALACOS® MV+G pro system consists of a mixing and application system prefilled with PALACOS® polymer powder and monomer liquid. PALACOS® MV+G pro is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.
2021-07-15
PALACOS® - The PALACOS® MV+G pro system consists of a mixing and application system prefilled with PALACOS® polymer powder and monomer liquid. PALACOS® MV+G pro is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.
2021-07-15
PALACOS - PALACOS® LV+G is a slow-curing, radiopaque, poly(methyl methacrylate)-based bone cement. It contains the aminoglycoside antibiotic gentamicin.PALACOS® LV+G contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field PALACOS® LV+G has been coloured with chlorophyll (E141).The bone cement is prepared directly before use by mixing a polymer powder component with a liquid monomer component. A ductile dough forms which cures within a few minutes.
2017-09-01
PALACOS® - PALACOS® LV+G is a slow-curing, radiopaque, poly(methyl methacrylate)-based bone cement. It contains the aminoglycoside antibiotic gentamicin.PALACOS® LV+G contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field PALACOS® LV+G has been coloured with chlorophyll (E141).The bone cement is prepared directly before use by mixing a polymer powder component with a liquid monomer component. A ductile dough forms which cures within a few minutes.
2018-01-01
COPAL® knee mould Trial M US - COPAL® knee mould Trials are an accessory device for intraoperative determination of the correct size of spacer made from COPAL® knee moulds (Size S: 5159868, Size M: 5159869, Size L: 5159870). COPAL® knee mould Trials are used for a very short period of time (few minutes) during the first stage of a two-stage exchange revision procedure due to a septic process after thorough debridement and are intended for single use. COPAL® knee mould Trials resemble the spacer made from COPAL® knee moulds in size, shape, and geometry. COPAL® knee mould Trials are easily distinguishable from COPAL® knee mould spacers due to their prominent blue color and the stamping “Do not implant”.
2023-06-25
COPAL® knee mould Trial L US - COPAL® knee mould Trials are an accessory device for intraoperative determination of the correct size of spacer made from COPAL® knee moulds (Size S: 5159868, Size M: 5159869, Size L: 5159870). COPAL® knee mould Trials are used for a very short period of time (few minutes) during the first stage of a two-stage exchange revision procedure due to a septic process after thorough debridement and are intended for single use. COPAL® knee mould Trials resemble the spacer made from COPAL® knee moulds in size, shape, and geometry. COPAL® knee mould Trials are easily distinguishable from COPAL® knee mould spacers due to their prominent blue color and the stamping “Do not implant”.
2023-06-25
COPAL® knee mould Trial S US - COPAL® knee mould Trials are an accessory device for intraoperative determination of the correct size of spacer made from COPAL® knee moulds (Size S: 5159868, Size M: 5159869, Size L: 5159870). COPAL® knee mould Trials are used for a very short period of time (few minutes) during the first stage of a two-stage exchange revision procedure due to a septic process after thorough debridement and are intended for single use. COPAL® knee mould Trials resemble the spacer made from COPAL® knee moulds in size, shape, and geometry. COPAL® knee mould Trials are easily distinguishable from COPAL® knee mould spacers due to their prominent blue color and the stamping “Do not implant”.
2023-06-25
PALACOS® - PALACOS® R is a fast-curing, radiopaque, poly(methyl methacrylate)-based bone cement.PALACOS ® R contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field PALACOS ® R has been coloured with chlorophyll (E141). The bone cement is prepared directly before use by mixing a polymer powder component with a liquid monomer component. A ductile dough forms which cures within a few minutes.
2018-01-01
PALACOS® - PALACOS® R+G is a fast setting polymer containing gentamicin, for use in bone surgery. Mixing of the two component system, consisting of a powder and a liquid, initially produces a liquid and then a paste, which is used to anchor the prosthesis to the bone. The hardened bone cement allows stable fixation of the prosthesis and Transfers all stresses produced in a movement to the bone via the large interface. Insoluble zirconium dioxide is included in the cement powder as an X ray contrast medium. The chlorophyll additive serves as optical marking of the bone cement at the site of the operation.
2018-01-01
PALACOS® - PALACOS® MV+G is indicated for use as bone cement in arthroplasty procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary. The cement is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.PALACOS® MV+G contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field PALACOS® MV+G has been coloured with chlorophyll (E141).The bone cement is prepared directly before use by mixing a polymer powder component with a liquid monomer component. A ductile dough forms which cures within a few minutes.
2018-03-16
PALACOS® - The PALACOS® R pro system consists of a mixing and application system prefilled with PALACOS® powder and monomer liquid. PALACOS® R pro is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.
2018-06-01
PALACOS® - The PALACOS® R+G pro system consists of a mixing and application system prefilled with PALACOS® R+G powder and monomer liquid. PALACOS® R+G pro is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.
2018-06-01
COPAL® knee moulds - COPAL® knee moulds are sterile single-use moulds used for the preparation of spacers that are intended as temporary knee replacements as part of two-stage septic joint prosthesis revision.COPAL® knee moulds comprise a tibial component and a femoral component, which together form a bearing and move against one another. They can be used in both the right and the left knee joint. The spacer function provides that after removal of the prosthesis the existing joint space is retained and contraction of the musculature and the surrounding tissues is preventedCOPAL® knee moulds are intended for single use and must not be re-used or resterilised.
2023-04-21