Identity
- Trade Name
- TLC Uni Knee Meniscal Insert FDA UDI
- Generic Name
- Unicondylar knee prosthesis FDA UDI
- Model / Reference
- 121-21-2501 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09348215077624 FDA UDI
- 510(k) Number
- K212870 FDA UDI
- FDA Product Code
- HSX FDA UDI
- GMDN Term
- Unicondylar knee prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3520 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
Yes
FDA UDI
Category: Unicondylar knee prosthesis
TLC Uni Knee Meniscal Insert by Signature Orthopaedics Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Unicondylar knee prosthesis.
- Engage Partial Knee System — Engage Uni, LLC · Class II
- Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
- Oxford® Partial Knee System — Biomet Orthopedics, Inc. · Class II
- LEGION — Smith & Nephew, Inc. · Class II
- RESTORIS ESYNTIAL — MAKO Surgical Corp. · Class II
- RESTORIS ESYNTIAL — MAKO Surgical Corp. · Class II
- Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
- GENESIS II — Smith & Nephew, Inc. · Class II
Cleared under the same submission
K212870 also covers:
- Freedom — MAXX ORTHOPEDICS INC.
- Freedom — MAXX ORTHOPEDICS INC.
- Freedom — MAXX ORTHOPEDICS INC.
- Freedom — MAXX ORTHOPEDICS INC.
- Freedom — MAXX ORTHOPEDICS INC.
- Freedom — MAXX ORTHOPEDICS INC.
- Freedom — MAXX ORTHOPEDICS INC.
- Freedom — MAXX ORTHOPEDICS INC.
- Freedom — MAXX ORTHOPEDICS INC.
- Freedom — MAXX ORTHOPEDICS INC.
- Freedom — MAXX ORTHOPEDICS INC.
- Freedom — MAXX ORTHOPEDICS INC.
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
- Signature Orthopaedics Pty Ltd
Sources (1)
- FDA UDI 81355bed-7cc4-479e-9767-e8a86ba10c3e 33 fields · synced May 30, 2026