Home GUDID 15060155712151
Synicem Knee Spacer L65
Primary DI 15060155712151
Brand Synicem Knee Spacer L65
Company BIOCOMPOSITES LTD
Model 885441
Catalog number 885441
Device description 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)
Published 2025-07-08
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
Sterile true
Single use true
Product Codes# Code, Name table Code Name LXH Orthopedic Manual Surgical Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LXH Orthopedic Manual Surgical Instrument Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 15060155712151 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 15060155712151 15060155712151
GMDN Terms# Term, Definition table Term Definition Orthopaedic cement spacer A prefabricated device made of orthopaedic bone cement [e.g., polymethylmethacrylate (PMMA)], with an appropriate antibiotic, that is temporarily placed into a joint space to function as a carrier for the local delivery of antibiotic drugs and to prevent bone-on-bone contact and contraction of soft-tissue during surgical treatment of an infected joint. The shape and size of the device is modified to fit the joint space. This non-weight-bearing spacer remains in place until the infection clears; it is then removed and replaced with a conventional joint prosthesis. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Regulatory Flags# DUNS number 424382307 Device count 1 Combination product true Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810130207435 MSI Modern Surgical Instruments LLC LXH 2026-07-14 00840606188128 Ventana A SPINAL ELEMENTS, INC. LXH 2026-07-13 08809695601903 AnyPlus® GS Medical Co., Ltd. LXH 2026-04-21 08800322742945 PYXIS 3D Titanium Cervical Cage System GS Medical Co., Ltd. LXH 2025-12-18 08800322742952 PYXIS 3D Titanium Cervical Cage System GS Medical Co., Ltd. LXH 2025-12-18 08800322742969 PYXIS 3D Titanium Cervical Cage System GS Medical Co., Ltd. LXH 2025-12-18 08800322742976 PYXIS 3D Titanium Cervical Cage System GS Medical Co., Ltd. LXH 2025-12-18 08800322742983 PYXIS 3D Titanium Cervical Cage System GS Medical Co., Ltd. LXH 2025-12-18 08800322742990 PYXIS 3D Titanium Cervical Cage System GS Medical Co., Ltd. LXH 2025-12-18 08800322743003 PYXIS 3D Titanium Cervical Cage System GS Medical Co., Ltd. LXH 2025-12-18 08800322743010 PYXIS 3D Titanium Cervical Cage System GS Medical Co., Ltd. LXH 2025-12-18 08800322743027 PYXIS 3D Titanium Cervical Cage System GS Medical Co., Ltd. LXH 2025-12-18 08800322743034 PYXIS 3D Titanium Cervical Cage System GS Medical Co., Ltd. LXH 2025-12-18 08800322743041 PYXIS 3D Titanium Cervical Cage System GS Medical Co., Ltd. LXH 2025-12-18 08800322743058 PYXIS 3D Titanium Cervical Cage System GS Medical Co., Ltd. LXH 2025-12-18 08800322743065 PYXIS 3D Titanium Cervical Cage System GS Medical Co., Ltd. LXH 2025-12-18 08800322743072 PYXIS 3D Titanium Cervical Cage System GS Medical Co., Ltd. LXH 2025-12-18 08800322743089 PYXIS 3D Titanium Cervical Cage System GS Medical Co., Ltd. LXH 2025-12-18 08800322743096 PYXIS 3D Titanium Cervical Cage System GS Medical Co., Ltd. LXH 2025-12-18 08800322743102 PYXIS 3D Titanium Cervical Cage System GS Medical Co., Ltd. LXH 2025-12-18 08800322743119 PYXIS 3D Titanium Cervical Cage System GS Medical Co., Ltd. LXH 2025-12-18 08800322743126 PYXIS 3D Titanium Cervical Cage System GS Medical Co., Ltd. LXH 2025-12-18 08800322743133 PYXIS 3D Titanium Cervical Cage System GS Medical Co., Ltd. LXH 2025-12-18 08800322743140 PYXIS 3D Titanium Cervical Cage System GS Medical Co., Ltd. LXH 2025-12-18 08800322743157 PYXIS 3D Titanium Cervical Cage System GS Medical Co., Ltd. LXH 2025-12-18 08800322743171 PYXIS 3D Titanium Cervical Cage System GS Medical Co., Ltd. LXH 2025-12-18 08800322743188 PYXIS 3D Titanium Cervical Cage System GS Medical Co., Ltd. LXH 2025-12-18 08800322743195 PYXIS 3D Titanium Cervical Cage System GS Medical Co., Ltd. LXH 2025-12-18 08800322743201 PYXIS 3D Titanium Cervical Cage System GS Medical Co., Ltd. LXH 2025-12-18 08800322743218 PYXIS 3D Titanium Cervical Cage System GS Medical Co., Ltd. LXH 2025-12-18