Identity
- Trade Name
- UKNEE Tibial insert, plained FDA UDI
- Generic Name
- Cruciate-retaining total knee prosthesis FDA UDI
- Device Name
- UKNEE Tibial insert,plained,medium,13mm FDA UDI
- Model / Reference
- 2301-1213 FDA UDI
- Description
- UKNEE Tibial insert,plained,medium,13mm FDA UDI
Identifiers
- Catalog Number
- 2301-1213 FDA UDI
- Primary DI / UDI-DI
- 04712602346320 FDA UDI
- 510(k) Number
- K021657 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Cruciate-retaining total knee prosthesis 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
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
Category: Cruciate-retaining total knee prosthesis
The UKNEE Tibial insert, plained is a cruciate-retaining total knee prosthesis designed to replace damaged or degenerative knee joints. This implantable artificial substitute for the knee joint provides stability and support to the surrounding tissues.
Similar devices
Also classified as Cruciate-retaining total knee prosthesis.
- Arthrex® — Arthrex, Inc. · Class II
- Columbus® UC — AESCULAP, INC. · Class II
- Optimotion Blue CR HCCR Total Knee System — OPTIMOTION IMPLANTS, LLC · Class II
- B-P TOTAL KNEE SYSTEM — ENDOTEC, INC. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
Cleared under the same submission
K021657 also covers:
- UKNEE Femoral component, non-porous coated — UNITED ORTHOPEDIC CORP.
- UKNEE Femoral component, non-porous coated — UNITED ORTHOPEDIC CORP.
- UKNEE Femoral component, non-porous coated — UNITED ORTHOPEDIC CORP.
- UKNEE Femoral component, non-porous coated — UNITED ORTHOPEDIC CORP.
- UKNEE Femoral component, non-porous coated — UNITED ORTHOPEDIC CORP.
- UKNEE Femoral component, non-porous coated — UNITED ORTHOPEDIC CORP.
- UKNEE Femoral component, porous coated — UNITED ORTHOPEDIC CORP.
- UKNEE Femoral component, porous coated — UNITED ORTHOPEDIC CORP.
- UKNEE Femoral component, porous coated — UNITED ORTHOPEDIC CORP.
- UKNEE Femoral component, porous coated — UNITED ORTHOPEDIC CORP.
- UKNEE Femoral component, porous coated — UNITED ORTHOPEDIC CORP.
- UKNEE Femoral component, posterior stabilized — UNITED ORTHOPEDIC CORP.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- United Orthopedic Corp.
Sources (1)
- FDA UDI d8ff7173-50d3-44bf-964a-a8e5a347df69 37 fields · synced Jul 18, 2026