Identity
- Trade Name
- AXIOM® FDA UDI
- Generic Name
- Coated knee femur prosthesis FDA UDI
- Device Name
- AXIOM® PRIMARY FEMORAL 85mm LEFT POROUS FDA UDI
- Model / Reference
- 1280LT8500 FDA UDI
- Description
- AXIOM® PRIMARY FEMORAL 85mm LEFT POROUS FDA UDI
Identifiers
- Catalog Number
- 1280LT8500 FDA UDI
- Primary DI / UDI-DI
- M6841280LT85001 FDA UDI
- 510(k) Number
- K894334 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Coated knee femur 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 85 Millimeter FDA UDI
Category: Coated knee femur prosthesis
Axiom® by MicroPort Orthopedics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coated knee femur prosthesis.
- PHYSICA POROUS PS — Limacorporate · Class II
- GMK Primary Total Knee System — Medacta International · Class II
- PHYSICA POROUS KR — Limacorporate · Class II
- PERSONA™ Trabecular Metal™ — Zimmer, Inc. · Class II
- PERSONA™ Trabecular Metal™ — Zimmer, Inc. · Class II
- Persona® PPS® — Zimmer, Inc. · Class II
- Genflex2 Total Knee System — GLOBUS MEDICAL, INC. · Class II
- SIGMA — DEPUY (IRELAND) · Class II
Cleared under the same submission
K894334 also covers:
- ADVANCE® — MicroPort Orthopedics Inc.
- ADVANCE® — MicroPort Orthopedics Inc.
- ADVANCE® — MicroPort Orthopedics Inc.
- ADVANCE® — MicroPort Orthopedics Inc.
- ADVANCE® — MicroPort Orthopedics Inc.
- AXIOM® — MicroPort Orthopedics Inc.
- AXIOM® — MicroPort Orthopedics Inc.
- AXIOM® — MicroPort Orthopedics Inc.
- AXIOM® — MicroPort Orthopedics Inc.
- AXIOM® — MicroPort Orthopedics Inc.
- AXIOM® — MicroPort Orthopedics Inc.
- AXIOM® — MicroPort Orthopedics 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
- MicroPort Orthopedics Inc.
Sources (1)
- FDA UDI e51cd759-1367-406d-8f7e-705bd4560504 37 fields · synced Jun 9, 2026