Identity
- Trade Name
- Unity Total Knee System FDA UDI
- Generic Name
- Tibial insert FDA UDI
- Device Name
- Unity Tibial Insert PS Fixed Size 3 14mm FDA UDI
- Model / Reference
- 112.016.46 FDA UDI
- Description
- Unity Tibial Insert PS Fixed Size 3 14mm FDA UDI
Identifiers
- Catalog Number
- 112.016.46 FDA UDI
- Primary DI / UDI-DI
- 05055343875247 FDA UDI
- 510(k) Number
- K113060 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Tibial insert FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Tibial insert
The Unity Total Knee System is a precision-engineered implantable device designed to articulate the femoral and tibial components of primary or revision bicondylar knee joint replacement. Made from metal and/or polyethylene, this one-piece contoured insert offers superior lateral rotation and anterior/posterior movement, better reproducing the flexion of the knee joint compared to other devices on the market.
Similar devices
Also classified as Tibial insert.
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- P.F.C. SIGMA — DEPUY (IRELAND) · Class II
- Truliant, Activit-E — Exactech, Inc. · Class II
- Maxim Knee System — Biomet Orthopedics, Inc. · Class II
- Scorpio — Howmedica Osteonics Corp. · Class II
- TriVerse Meniscal Insert PS+ — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- Scorpio — Howmedica Osteonics Corp. · Class II
- World Knee System — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
Cleared under the same submission
K113060 also covers:
- Unity Total Knee System — CORIN LTD
- Unity Total Knee System — CORIN LTD
- Unity Total Knee System — CORIN LTD
- Unity Total Knee System — CORIN LTD
- Unity Total Knee System — CORIN LTD
- Unity Total Knee System — CORIN LTD
- Unity Total Knee System — CORIN LTD
- Unity Total Knee System — CORIN LTD
- Unity Total Knee System — CORIN LTD
- Unity Total Knee System — CORIN LTD
- Unity Total Knee System — CORIN LTD
- Unity Total Knee System — CORIN LTD
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Corin Ltd
Sources (1)
- FDA UDI 30ad0cc9-9752-4413-bb30-0dc30281f473 36 fields · synced Jun 19, 2026