Identity
- Trade Name
- CATALYSTEM FDA UDI
- Generic Name
- Coated hip femur prosthesis, modular FDA UDI
- Device Name
- CATALYSTEM COLLARED STEM STANDARD OFFSET SIZE 3 FDA UDI
- Model / Reference
- 71314023 FDA UDI
- Description
- CATALYSTEM COLLARED STEM STANDARD OFFSET SIZE 3 FDA UDI
Identifiers
- Catalog Number
- 71314023 FDA UDI
- Primary DI / UDI-DI
- 00885556891599 FDA UDI
- 510(k) Number
- K240381 FDA UDI
- FDA Product Code
- LPH FDA UDILZO FDA UDIMEH FDA UDI
- GMDN Term
- Coated hip femur prosthesis, modular FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 FDA UDI888.3353 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
MR Conditional FDA UDI
Category: Coated hip femur prosthesis, modular
Catalystem by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coated hip femur prosthesis, modular.
- LCU Hip Stem — WALDEMAR LINK GmbH & Co. KG · Class II
- ABG — Howmedica Osteonics Corp. · Class II
- Z1™ Hip System — Zimmer, Inc. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- VerSys® — Zimmer, Inc. · Class II
- Everglade Stem, Standard Offset — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- Excia® L — AESCULAP, INC. · Class II
- Metafix Hip Stem — CORIN LTD · Class II
Cleared under the same submission
K240381 also covers:
- CATALYSTEM — Smith & Nephew, Inc.
- CATALYSTEM — Smith & Nephew, Inc.
- CATALYSTEM — Smith & Nephew, Inc.
- CATALYSTEM — Smith & Nephew, Inc.
- CATALYSTEM — Smith & Nephew, Inc.
- CATALYSTEM — Smith & Nephew, Inc.
- CATALYSTEM — Smith & Nephew, Inc.
- CATALYSTEM — Smith & Nephew, Inc.
- CATALYSTEM — Smith & Nephew, Inc.
- CATALYSTEM — Smith & Nephew, Inc.
- CATALYSTEM — Smith & Nephew, Inc.
- CATALYSTEM — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 3780ef8b-bb99-4d53-8d79-1e6f839c0b8c 37 fields · synced Jun 8, 2026