Identity
- Trade Name
- EVOLUTION® FDA UDI
- Generic Name
- Knee femur stem prosthesis FDA UDI
- Model / Reference
- ESP10150 FDA UDI
Identifiers
- Catalog Number
- ESP10150 FDA UDI
- Primary DI / UDI-DI
- M684ESP101501 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Knee femur stem 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
- Outer Diameter — 10 Millimeter FDA UDILength — 150 Millimeter FDA UDI
Category: Knee femur stem prosthesis
Evolution® by MicroPort Orthopedics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Knee femur stem prosthesis.
- Endo-Model Standard Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG · Class II
- Biomet Knee System — Biomet Orthopedics, Inc. · Class II
- Unity Total Knee System — CORIN LTD · Class II
- LINK Endo-Model EVO — WALDEMAR LINK GmbH & Co. KG · Class II
- OPTILOCK PERIARTICULAR PLATING SYSTEM — Biomet Orthopedics, Inc. · Class II
- Modular Stem, — WALDEMAR LINK GmbH & Co. KG · Class II
- LINK Endo-Model EVO Knee System — WALDEMAR LINK GmbH & Co. KG · Class II
- Finn® Knee System — Biomet Orthopedics, Inc. · Class II
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
- MicroPort Orthopedics Inc.
Sources (1)
- FDA UDI ba305e23-02cb-4113-817a-07e0a1c5f8a4 35 fields · synced Jun 9, 2026