Identity
- Trade Name
- SIGMA FDA UDI
- Generic Name
- Uncoated unicondylar knee tibia prosthesis, polyethylene FDA UDI
- Device Name
- SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT UNICONDYLAR ALL POLYETHYLENE SIZE 3 9mm RM/LL XLK FDA UDI
- Model / Reference
- 1024-12-309 FDA UDI
- Description
- SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT UNICONDYLAR ALL POLYETHYLENE SIZE 3 9mm RM/LL XLK FDA UDI
Identifiers
- Catalog Number
- 102412309 FDA UDI
- Primary DI / UDI-DI
- 10603295002161 FDA UDI
- FDA Product Code
- NPJ FDA UDIKRR FDA UDIHRY FDA UDI
- GMDN Term
- Uncoated unicondylar knee tibia prosthesis, polyethylene FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 FDA UDI888.3540 FDA UDI888.3530 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
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
No
FDA UDI
MR Conditional FDA UDI
Category: Uncoated unicondylar knee tibia prosthesis, polyethylene
Sigma by Depuy (ireland) — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uncoated unicondylar knee tibia prosthesis, polyethylene.
- JOURNEY — Smith & Nephew, Inc. · Class II
- RESTORIS — MAKO Surgical Corp. · Class II
- HLS Uni Evolution — CORIN LTD · Class II
- ZUK — Smith & Nephew, Inc. · Class II
- ZUK — Smith & Nephew, Inc. · Class II
- JOURNEY — Smith & Nephew, Inc. · Class II
- Unicondylar Sled Prosthesis — WALDEMAR LINK GmbH & Co. KG · Class II
- MOTO Lateral Partial Knee System — Medacta International · Class II
Cleared under the same submission
K061648 also covers:
K070849 also covers:
K233980 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Depuy (ireland)
Sources (1)
- FDA UDI 27ea5ed0-7a06-4ad4-97a9-e9a6f5803ee0 36 fields · synced Jun 8, 2026