Identity
- Trade Name
- Synicem Shoulder Spacer 48H FDA UDI
- Generic Name
- Orthopaedic cement spacer FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 885447 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15060155712229 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
Yes
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 Shoulder Spacer 48H by Biocomposites Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic cement spacer.
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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 cbf9b4af-b1df-471b-8887-1e39b50355fe 36 fields · synced Jun 6, 2026