Identity
- Trade Name
- GENESIS FDA UDI
- Generic Name
- Uncoated unicondylar knee femur prosthesis FDA UDI
- Device Name
- GENISIS UNI FEMORAL MAGNUM PLUS FDA UDI
- Model / Reference
- 71245007 FDA UDI
- Description
- GENISIS UNI FEMORAL MAGNUM PLUS FDA UDI
Identifiers
- Catalog Number
- 71245007 FDA UDI
- Primary DI / UDI-DI
- 03596010188519 FDA UDI
- 510(k) Number
- K912735 FDA UDI
- FDA Product Code
- HSX FDA UDI
- GMDN Term
- Uncoated unicondylar knee femur 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
No
FDA UDI
Category: Uncoated unicondylar knee femur prosthesis
Genesis by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uncoated unicondylar knee femur prosthesis.
- HLS Uni Evolution — CORIN LTD · Class II
- Unicondylar Knee System — GLOBUS MEDICAL, INC. · Class II
- iUni® Femoral Kit — Conformis, Inc. · Class II
- Persona® Partial Knee System — Biomet Orthopedics, Inc. · Class II
- Unicondylar Knee System — GLOBUS MEDICAL, INC. · Class II
- Unicondylar Sled Prosthesis — WALDEMAR LINK GmbH & Co. KG · Class II
- Uniglide Unicondylar Knee Prosthesis — CORIN LTD · Class II
- AS univation® XF — AESCULAP, INC. · Class II
Cleared under the same submission
K912735 also covers:
- GENESIS — Smith & Nephew, Inc.
- GENESIS — Smith & Nephew, Inc.
- GENESIS — Smith & Nephew, Inc.
- GENESIS — Smith & Nephew, Inc.
- GENESIS — Smith & Nephew, Inc.
- GENESIS — Smith & Nephew, Inc.
- GENESIS — Smith & Nephew, Inc.
- GENESIS — Smith & Nephew, Inc.
- GENESIS — Smith & Nephew, Inc.
- GENESIS — Smith & Nephew, Inc.
- GENESIS — Smith & Nephew, Inc.
- GENESIS — Smith & Nephew, 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
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 490f1291-7d12-4815-a227-0f5263233884 36 fields · synced Jun 8, 2026