biocomposites.comSynicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer
Biocomposites, Ltd.
BIOCOMPOSITES, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1065982 | 3003029518 | BIOCOMPOSITES, INC. | 1 | Y | 2026-01-01 | 700 Military Cutoff Rd Ste 320 Wilmington NC US 28405 |
| 3011483489 | 3011483489 | Biocomposites GmbH (former ARTOSS GmbH) | 1 | N | 2026-01-01 | Fischerweg 421 Rostock Mecklenburg-Western Pomerania DE 18069 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 15060155712021 | Synicem Hip Spacer 40C - Synicem 40C Hip Spacer. Charnley Stem Type, 40mm Head, 127 mm Stem Length. Temporary implant which main function is to preserve the articular space during 2 Stage Revision Arthroplasty. Aids in treatment of infection that emerged due to the implant of hip replacement prosthesis. The hip spacer with gentamicin has a surgical steel core coated with radiopaque (barium sulfate) bone cement (PMMA) with antibiotic (gentamicin base). This is a long-term use implant, intended to be used for a maximum period of 180 days. | +441782338580 | info@biocomposites.com |
| 15060155712038 | Synicem Hip Spacer 48C - Charnley Stem Type, 48mm Head, 130 mm Stem Length. Temporary implant which main function is to preserve the articular space during 2 Stage Revision Arthroplasty. Aids in treatment of infection that emerged due to the implant of hip replacement prosthesis. The hip spacer with gentamicin has a surgical steel core coated with radiopaque (barium sulfate) bone cement (PMMA) with antibiotic (gentamicin base). This is a long-term use implant, intended to be used for a maximum period of 180 days. | +441782338580 | info@biocomposites.com |
| 15060155712045 | Synicem Hip Spacer 56C - Charnley Stem Type, 56mm Head, 130 mm Stem Length. Temporary implant which main function is to preserve the articular space during 2 Stage Revision Arthroplasty. Aids in treatment of infection that emerged due to the implant of hip replacement prosthesis. The hip spacer with gentamicin has a surgical steel core coated with radiopaque (barium sulfate) bone cement (PMMA) with antibiotic (gentamicin base). This is a long-term use implant, intended to be used for a maximum period of 180 days. | +441782338580 | info@biocomposites.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 181556 | 1536650282 | K250521 | NanoBone® SBX Putty ; NanoBone® QD | MQV | 2025-04-07 |
| 181556 | 1685678101 | K190110 | NanoBone SBX PUTTY, NanoBone QD | MQV | 2019-04-23 |
| 181556 | 1627341209 | K161351 | NanoBone SBX Putty | MQV | 2016-10-26 |
| 181556 | 1824332571 | K141189 | NANOBONE / GRANULATE | MQV | 2015-01-30 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| MQV | 4 | 2025-04-07 |
PMN#
Genex Bone Graft Substitute
Biocomposites Ltd
STIMULAN KIT, STIMULAN RAPID CURE
BIOCOMPOSITES LTD.
GENEX
BIOCOMPOSITES LTD.
FORTOSS VITAL
BIOCOMPOSITES LTD.
GENEX PUTTY
BIOCOMPOSITES LTD.
MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR
BIOCOMPOSITES LTD.
GRAFTLOCK SCREW, ST SCREW
BIOCOMPOSITES LTD.
MODIFICATION TO BILOK SCREW
BIOCOMPOSITES LTD.
MODIFICATION TO BILOK ST SCREW
BIOCOMPOSITES LTD.
DOUBLEPLAY SUTURE ANCHOR
BIOCOMPOSITES LTD.
ALLOGRAN-R
BIOCOMPOSITES LTD.
FORTOSS VITAL BONE GRAFT SUBSTITUTE
BIOCOMPOSITES LTD.
LITTLE GRAFTER SCREW
BIOCOMPOSITES LTD.
GENEX BONE GRAFT SUBSTITUTE
BIOCOMPOSITES LTD.
BILOK ST SCREW
Biocomposites, Ltd.
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT
BIOCOMPOSITES LTD.
BIOSTEON CROSS PIN
BIOCOMPOSITES LTD.
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT
BIOCOMPOSITES LTD.
BIOLOK SCREW, BIOSTEON SCREW
BIOCOMPOSITES LTD.
BIOLOK SCREW
BIOCOMPOSITES LTD.
STIMULAN -CALCIUM SULFATE BONE VOID FILTER
BIOCOMPOSITES LTD.
FORTOSS-CEMA
BIOCOMPOSITES LTD.
GUDID#
Synicem Hip Spacer 40C - Synicem 40C Hip Spacer. Charnley Stem Type, 40mm Head, 127 mm Stem Length. Temporary implant which main function is to preserve the articular space during 2 Stage Revision Arthroplasty. Aids in treatment of infection that emerged due to the implant of hip replacement prosthesis. The hip spacer with gentamicin has a surgical steel core coated with radiopaque (barium sulfate) bone cement (PMMA) with antibiotic (gentamicin base). This is a long-term use implant, intended to be used for a maximum period of 180 days.
2025-07-08
Synicem Hip Spacer 48C - Charnley Stem Type, 48mm Head, 130 mm Stem Length. Temporary implant which main function is to preserve the articular space during 2 Stage Revision Arthroplasty. Aids in treatment of infection that emerged due to the implant of hip replacement prosthesis. The hip spacer with gentamicin has a surgical steel core coated with radiopaque (barium sulfate) bone cement (PMMA) with antibiotic (gentamicin base). This is a long-term use implant, intended to be used for a maximum period of 180 days.
2025-07-08
Synicem Hip Spacer 56C - Charnley Stem Type, 56mm Head, 130 mm Stem Length. Temporary implant which main function is to preserve the articular space during 2 Stage Revision Arthroplasty. Aids in treatment of infection that emerged due to the implant of hip replacement prosthesis. The hip spacer with gentamicin has a surgical steel core coated with radiopaque (barium sulfate) bone cement (PMMA) with antibiotic (gentamicin base). This is a long-term use implant, intended to be used for a maximum period of 180 days.
2025-07-08
Synicem Hip Spacer 40CXL - Charnley Stem Type, 40mm Head, 250 mm Stem Length. Temporary implant which main function is to preserve the articular space during 2 Stage Revision Arthroplasty. Aids in treatment of infection that emerged due to the implant of hip replacement prosthesis. The hip spacer with gentamicin has a surgical steel core coated with radiopaque (barium sulfate) bone cement (PMMA) with antibiotic (gentamicin base). This is a long-term use implant, intended to be used for a maximum period of 180 days.
2025-07-08
Synicem Hip Spacer 48CXL - Charnley Stem Type, 48mm Head, 250mm Stem Length Temporary implant which main function is to preserve the articular space during 2 Stage Revision Arthroplasty. Aids in treatment of infection that emerged due to the implant of hip replacement prosthesis. The hip spacer with gentamicin has a surgical steel core coated with radiopaque (barium sulfate) bone cement (PMMA) with antibiotic (gentamicin base). The gentamicin hip spacer is a long-term use implant, as it is intended to be used for a maximum period of 180 days.
2025-07-08
Synicem Hip Spacer 56CXL - Charnley Stem Type, 56mm Head, 250 mm Stem Length. Temporary implant which main function is to preserve the articular space during 2 Stage Revision Arthroplasty. Aids in treatment of infection that emerged due to the implant of hip replacement prosthesis. The hip spacer with gentamicin has a surgical steel core coated with radiopaque (barium sulfate) bone cement (PMMA) with antibiotic (gentamicin base). This is a long-term use implant, intended to be used for a maximum period of 180 days.
2025-07-08
Synicem Hip Spacer 48M - Muller Stem Type, 48mm Head, 120 mm Stem Length. Temporary implant which main function is to preserve the articular space during 2 Stage Revision Arthroplasty. Aids in treatment of infection that emerged due to the implant of hip replacement prosthesis. The hip spacer with gentamicin has a surgical steel core coated with radiopaque (barium sulfate) bone cement (PMMA) with antibiotic (gentamicin base). This is a long-term use implant, intended to be used for a maximum period of 180 days.
2025-07-08
Synicem Hip Spacer 56M - Muller Stem Type, 56mm Head, 127mm Stem Length. Temporary implant which main function is to preserve the articular space during 2 Stage Revision Arthroplasty. Aids in treatment of infection that emerged due to the implant of hip replacement prosthesis. The hip spacer with gentamicin has a surgical steel core coated with radiopaque (barium sulfate) bone cement (PMMA) with antibiotic (gentamicin base). This is a long-term use implant, intended to be used for a maximum period of 180 days.
2025-07-08
Synicem Hip Spacer Trial Tray Regular with Trials - 882022
2025-07-08
Synicem Hip Spacer Trial Tray XL with Trials - 882023
2025-07-08
Synicem Knee Spacer R58 - Asymmetric, Femoral/Tibia 58, Right Knee Spacer with gentamicin is a temporary implant whose main function is to preserve the articular space during a 2 Stage Revision Arthroplasty. Aids in the treatment of infection that emerged due to the implant of knee prosthesis. Once the patient has finished the specific treatment & no signs of the infection remain, the spacer is removed to be replaced by a definitive new prosthesis. This is a prolonged use implant (maximum intended use period of 180 days)
2025-07-08
Synicem Knee Spacer L58 - Asymmetric, Femoral/Tibia 58, Left Knee Spacer with gentamicin is a temporary implant whose main function is to preserve the articular space during a 2 Stage Revision Arthroplasty. Aids in the treatment of infection that emerged due to the implant of knee prosthesis. Once the patient has finished the specific treatment & no signs of the infection remain, the spacer is removed to be replaced by a definitive new prosthesis. This is a prolonged use implant (maximum intended use period of 180 days)
2025-07-08
Synicem Knee Spacer R65 - Asymmetric, Femoral/Tibia 65, Right Knee Spacer with gentamicin is a temporary implant whose main function is to preserve the articular space during a 2 Stage Revision Arthroplasty. Aids in the treatment of infection that emerged due to the implant of knee prosthesis. Once the patient has finished the specific treatment & no signs of the infection remain, the spacer is removed to be replaced by a definitive new prosthesis. This is a prolonged use implant (maximum intended use period of 180 days)
2025-07-08
Synicem Knee Spacer L65 - Asymmetric, Femoral/Tibia 58, Left Knee Spacer with gentamicin is a temporary implant whose main function is to preserve the articular space during a 2 Stage Revision Arthroplasty. Aids in the treatment of infection that emerged due to the implant of knee prosthesis. Once the patient has finished the specific treatment & no signs of the infection remain, the spacer is removed to be replaced by a definitive new prosthesis. This is a prolonged use implant (maximum intended use period of 180 days)
2025-07-08
Synicem Knee Spacer R72 - Asymmetric, Femoral/Tibia 72, Right Knee Spacer with gentamicin is a temporary implant whose main function is to preserve the articular space during a 2 Stage Revision Arthroplasty. Aids in the treatment of infection that emerged due to the implant of knee prosthesis. Once the patient has finished the specific treatment & no signs of the infection remain, the spacer is removed to be replaced by a definitive new prosthesis. This is a prolonged use implant (maximum intended use period of 180 days)
2025-07-08
Synicem Knee Spacer L72 - Asymmetric, Femoral/Tibia 72, Left Knee Spacer with gentamicin is a temporary implant whose main function is to preserve the articular space during a 2 Stage Revision Arthroplasty. Aids in the treatment of infection that emerged due to the implant of knee prosthesis. Once the patient has finished the specific treatment & no signs of the infection remain, the spacer is removed to be replaced by a definitive new prosthesis. This is a prolonged use implant (maximum intended use period of 180 days)
2025-07-08
Synicem Knee Spacer R79 - Asymmetric, Femoral/Tibia 79, Right Knee Spacer with gentamicin is a temporary implant whose main function is to preserve the articular space during a 2 Stage Revision Arthroplasty. Aids in the treatment of infection that emerged due to the implant of knee prosthesis. Once the patient has finished the specific treatment & no signs of the infection remain, the spacer is removed to be replaced by a definitive new prosthesis. This is a prolonged use implant (maximum intended use period of 180 days)
2025-07-08
Synicem Knee Spacer L79 - Asymmetric, Femoral/Tibia 79, Left Knee Spacer with gentamicin is a temporary implant whose main function is to preserve the articular space during a 2 Stage Revision Arthroplasty. Aids in the treatment of infection that emerged due to the implant of knee prosthesis. Once the patient has finished the specific treatment & no signs of the infection remain, the spacer is removed to be replaced by a definitive new prosthesis. This is a prolonged use implant (maximum intended use period of 180 days)
2025-07-08
Synicem Knee Spacer Trial Tray with Trials - 882024
2025-07-08
Synicem Shoulder Spacer 40H - 40 mm Head, 120 mm Stem Length Shoulder spacer with gentamicin is a temporary implant whose main function is to maintain joint space in the interval between 2 stage revision arthroplasties. Aids in treatment of infection originating in the implant of shoulder prosthesis. Shoulder spacer has a surgical steel center coated with radiopaque (barium sulfate) bone cement (PMMA) with antibiotic (gentamicin base). This is a long-term use implant, intended to be used for a maximum period of 180 days.
2025-07-08
Synicem Shoulder Spacer 48H - 48mm Head, 120 mm Stem Length Shoulder spacer with gentamicin is a temporary implant whose main function is to maintain joint space in the interval between 2 stage revision arthroplasties. Aids in treatment of infection originating in the implant of shoulder prosthesis. Shoulder spacer has a surgical steel center coated with radiopaque (barium sulfate) bone cement (PMMA) with antibiotic (gentamicin base). This is a long-term use implant, intended to be used for a maximum period of 180 days.
2025-07-08
Synicem Shoulder Spacer Trial Tray with Trials - 882052
2025-07-08
Synicem 40C Hip Trial FDA - Synicem 40C Hip Spacer Trials FDA. Reusable Hip Trial Spacer allows for the selection of the correct hip spacer to avoid manipulation prior to implantation during a 2-step revision hip arthroplasty. Reproduce the shape & size of the corresponding spacers. Provided non-sterile. Medical or surgical support personnel using the “Trial Spacer” should familiarize themselves with the product within the context of their duties & responsibilities prior to use. These accessories are for momentary use.
2025-07-08
Synicem 48C Hip Trial FDA - Reusable Hip Trial Spacer allows for the selection of the correct hip spacer to avoid manipulation prior to implantation during a 2-step revision hip arthroplasty. Reproduce the shape & size of the corresponding spacers. Provided non-sterile. Medical or surgical support personnel using the “Trial Spacer” should familiarize themselves with the product within the context of their duties & responsibilities prior to use. These accessories are for momentary use.
2025-07-08
Synicem 48M Hip Trial FDA - Reusable Hip Trial Spacer allows for the selection of the correct hip spacer to avoid manipulation prior to implantation during a 2-step revision hip arthroplasty. Reproduce the shape & size of the corresponding spacers. Provided non-sterile. Medical or surgical support personnel using the “Trial Spacer” should familiarize themselves with the product within the context of their duties & responsibilities prior to use. These accessories are for momentary use.
2025-07-08
Synicem 56C Hip Trial FDA - Reusable Hip Trial Spacer allows for the selection of the correct hip spacer to avoid manipulation prior to implantation during a 2-step revision hip arthroplasty. Reproduce the shape & size of the corresponding spacers. Provided non-sterile. Medical or surgical support personnel using the “Trial Spacer” should familiarize themselves with the product within the context of their duties & responsibilities prior to use. These accessories are for momentary use.
2025-07-08
Synicem 56M Hip Trial FDA - Reusable Hip Trial Spacer allows for the selection of the correct hip spacer to avoid manipulation prior to implantation during a 2-step revision hip arthroplasty. Reproduce the shape & size of the corresponding spacers. Provided non-sterile. Medical or surgical support personnel using the “Trial Spacer” should familiarize themselves with the product within the context of their duties & responsibilities prior to use. These accessories are for momentary use.
2025-07-08
Synicem Hip Trial 40CXL FDA - Reusable Hip Trial Spacer allows for the selection of the correct hip spacer to avoid manipulation prior to implantation during a 2-step revision hip arthroplasty. Reproduce the shape & size of the corresponding spacers. Provided non-sterile. Medical or surgical support personnel using the “Trial Spacer” should familiarize themselves with the product within the context of their duties & responsibilities prior to use. These accessories are for momentary use.
2025-07-08
Synicem Hip Trial 48CXL FDA - Reusable Hip Trial Spacer allows for the selection of the correct hip spacer to avoid manipulation prior to implantation during a 2-step revision hip arthroplasty. Reproduce the shape & size of the corresponding spacers. Provided non-sterile. Medical or surgical support personnel using the “Trial Spacer” should familiarize themselves with the product within the context of their duties & responsibilities prior to use. These accessories are for momentary use.
2025-07-08
Synicem 56CXL Hip Trial FDA - Reusable Hip Trial Spacer allows for the selection of the correct hip spacer to avoid manipulation prior to implantation during a 2-step revision hip arthroplasty. Reproduce the shape & size of the corresponding spacers. Provided non-sterile. Medical or surgical support personnel using the “Trial Spacer” should familiarize themselves with the product within the context of their duties & responsibilities prior to use. These accessories are for momentary use.
2025-07-08
Synicem 58 Knee Trial FDA - Reusable Knee Trial Spacer allows for the selection of the correct knee spacer to avoid manipulation prior to implantation during a 2-step revision knee arthroplasty. Reproduce the shape & size of the corresponding spacers. Provided non-sterile. Medical or surgical support personnel using the “Knee Trial Spacer” should familiarize themselves with the product within the context of their duties & responsibilities prior to use. These accessories are for momentary use.
2025-07-08
Synicem 65 Knee Trial FDA - Reusable Knee Trial Spacer allows for the selection of the correct knee spacer to avoid manipulation prior to implantation during a 2-step revision knee arthroplasty. Reproduce the shape & size of the corresponding spacers. Provided non-sterile. Medical or surgical support personnel using the “Knee Trial Spacer” should familiarize themselves with the product within the context of their duties & responsibilities prior to use. These accessories are for momentary use.
2025-07-08
Synicem 72 Knee Trial FDA - Reusable Knee Trial Spacer allows for the selection of the correct knee spacer to avoid manipulation prior to implantation during a 2-step revision knee arthroplasty. Reproduce the shape & size of the corresponding spacers. Provided non-sterile. Medical or surgical support personnel using the “Knee Trial Spacer” should familiarize themselves with the product within the context of their duties & responsibilities prior to use. These accessories are for momentary use.
2025-07-08
Synicem 79 Knee Trial FDA - Reusable Knee Trial Spacer allows for the selection of the correct knee spacer to avoid manipulation prior to implantation during a 2-step revision knee arthroplasty. Reproduce the shape & size of the corresponding spacers. Provided non-sterile. Medical or surgical support personnel using the “Knee Trial Spacer” should familiarize themselves with the product within the context of their duties & responsibilities prior to use. These accessories are for momentary use.
2025-07-08
Synicem 48H Shoulder Trial FDA - Reusable Shoulder Trial Spacer allows for the selection of the correct shoulder spacer to avoid manipulation prior to implantation during a 2-step revision shoulder arthroplasty. Reproduce the shape & size of the corresponding spacers. Provided non-sterile. Medical or surgical support personnel using the “shoulder Trial Spacer” should familiarize themselves with the product within the context of their duties & responsibilities prior to use. These accessories are for momentary use.
2025-07-08
Synicem 40H Shoulder Trial FDA - Reusable Shoulder Trial Spacer allows for the selection of the correct shoulder spacer to avoid manipulation prior to implantation during a 2-step revision shoulder arthroplasty. Reproduce the shape & size of the corresponding spacers. Provided non-sterile. Medical or surgical support personnel using the “shoulder Trial Spacer” should familiarize themselves with the product within the context of their duties & responsibilities prior to use. These accessories are for momentary use.
2025-07-08
Synicem Hip Spacer Trial Case (marked) Regular - 515091
2025-07-08
Synicem Hip Spacer Trial Case (marked) XL - 515093
2025-07-08
Synicem Knee Spacer Trial Case (marked) - 515090
2025-07-08
Synicem Shoulder Spacer Trial Case (marked) - 515092
2025-07-08