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OMNI Knee
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref KC-36014Model APEX Knee System
Identity
- Trade Name
- APEX Knee System Size 1 x 14mm Ultra Tibial Insert EUDAMEDOMNI Knee FDA UDI
- Generic Name
- Tibial insert FDA UDI
- Device Name
- Apex total knee tibial inserts for use as a primary or revision total knee replacement EUDAMEDUltra Tibial Insert CS, Size 1 x 14mm FDA UDI
- Model / Reference
- KC-36014 EUDAMEDFDA UDIAPEX Knee System EUDAMED
- Description
- Ultra Tibial Insert CS, Size 1 x 14mm FDA UDI
Identifiers
- Catalog Number
- KC-36014 FDA UDI
- Primary DI / UDI-DI
- 00841690101482 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00841690101482 EUDAMED
- FDA Product Code
- JWH FDA UDI
- EMDN Code
- P090903020202 BICOMPARTMENTAL PRIMARY IMPLANT FIXED BEARING TIBIAL INSERTS EUDAMED
- GMDN Term
- Tibial insert FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3560 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Ethylene Oxide FDA UDI
Category: Tibial insert
OMNI Knee by OMNIlife science, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Tibial insert.
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- Scorpio — Howmedica Osteonics Corp. · Class II
- World Knee System — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- OMNIlife science, Inc.
Sources (2)
- FDA UDI aed71d80-5c1c-469b-9dca-e2839aadf2a5 35 fields · synced Sep 30, 2026
- EUDAMED 266a11c4-9758-4dde-be68-3f79618831ad 61 fields · synced Sep 30, 2026