Identity
- Trade Name
- Synicem Knee Spacer R65 FDA UDI
- Generic Name
- Orthopaedic cement spacer FDA UDI
- Device Name
- 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) FDA UDI
- Model / Reference
- 885440 FDA UDI
- Description
- 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) FDA UDI
Identifiers
- Catalog Number
- 885440 FDA UDI
- Primary DI / UDI-DI
- 15060155712144 FDA UDI
- 510(k) Number
- K242865 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic cement spacer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Orthopaedic cement spacer
Synicem Knee Spacer R65 by Biocomposites Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K242865 also covers:
- Synicem Hip Spacer 40C — BIOCOMPOSITES LTD
- Synicem Hip Spacer 40CXL — BIOCOMPOSITES LTD
- Synicem Hip Spacer 48C — BIOCOMPOSITES LTD
- Synicem Hip Spacer 48CXL — BIOCOMPOSITES LTD
- Synicem Hip Spacer 48M — BIOCOMPOSITES LTD
- Synicem Hip Spacer 56C — BIOCOMPOSITES LTD
- Synicem Hip Spacer 56CXL — BIOCOMPOSITES LTD
- Synicem Hip Spacer 56M — BIOCOMPOSITES LTD
- Synicem Knee Spacer L58 — BIOCOMPOSITES LTD
- Synicem Knee Spacer L65 — BIOCOMPOSITES LTD
- Synicem Knee Spacer L72 — BIOCOMPOSITES LTD
- Synicem Knee Spacer L79 — BIOCOMPOSITES LTD
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biocomposites Ltd
Sources (1)
- FDA UDI 993e615a-87a7-4c36-a8b1-1c042a31b0b0 37 fields · synced May 30, 2026