Identity
- Trade Name
- HLS Uni Evolution FDA UDI
- Generic Name
- Uncoated unicondylar knee tibia prosthesis, polyethylene FDA UDI
- Device Name
- HLS uni Evolution Tibial component PE Size 3 Th9mm FDA UDI
- Model / Reference
- GDU132 FDA UDI
- Description
- HLS uni Evolution Tibial component PE Size 3 Th9mm FDA UDI
Identifiers
- Catalog Number
- GDU132 FDA UDI
- Primary DI / UDI-DI
- 05056139208355 FDA UDI
- 510(k) Number
- K022211 FDA UDI
- FDA Product Code
- HSX FDA UDI
- GMDN Term
- Uncoated unicondylar knee tibia prosthesis, polyethylene 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
No
FDA UDI
Radiation Sterilization FDA UDI
Category: Uncoated unicondylar knee tibia prosthesis, polyethylene
HLS Uni Evolution by Corin Ltd — 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
- SIGMA — DEPUY (IRELAND) · Class II
- RESTORIS — MAKO Surgical Corp. · 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
K022211 also covers:
- HLS Uni Evolution — CORIN LTD
- HLS Uni Evolution — CORIN LTD
- HLS Uni Evolution — CORIN LTD
- HLS Uni Evolution — CORIN LTD
- HLS Uni Evolution — CORIN LTD
- HLS Uni Evolution — CORIN LTD
- HLS Uni Evolution — CORIN LTD
- HLS Uni Evolution — CORIN LTD
- HLS Uni Evolution — CORIN LTD
- HLS Uni Evolution — CORIN LTD
- HLS Uni Evolution — CORIN LTD
- HLS Uni Evolution — CORIN 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Corin Ltd
Sources (1)
- FDA UDI e42923e1-9ea5-47ef-bf17-c2a270bef9ba 36 fields · synced May 30, 2026