Identity
- Trade Name
- Katalyst™ Bipolar Radial Head System FDA UDI
- Generic Name
- Elbow radius prosthesis FDA UDI
- Device Name
- The Katalyst Radial Stem restores the support and bearing surfaces of the radial head in the face of fracture, arthritis or failed prior implantation. FDA UDI
- Model / Reference
- 221675 FDA UDI
- Description
- The Katalyst Radial Stem restores the support and bearing surfaces of the radial head in the face of fracture, arthritis or failed prior implantation. FDA UDI
Identifiers
- Catalog Number
- 221675 FDA UDI
- Primary DI / UDI-DI
- 10381780065821 FDA UDI
- 510(k) Number
- K032806 FDA UDI
- FDA Product Code
- KWI FDA UDI
- GMDN Term
- Elbow radius prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3170 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
Category: Elbow radius prosthesis
The Katalyst Bipolar Radial Head System is a medical device designed to replace the proximal radius, typically as treatment for severe radial head fracture or degenerative disease (arthritis). This implantable device features a radial head or head with stem made of metal or metal and polyethylene, providing support and bearing surfaces.
Similar devices
Also classified as Elbow radius prosthesis.
- LATITUDE EV™ — TORNIER, INC. · Class II
- RHEAD — Stryker Corp. · Class II
- Seitz Solution Radial Head — Kapp Surgical Instrument, Inc. · Class II
- Seitz Solution Radial Head — Kapp Surgical Instrument, Inc. · Class II
- Avenger — In2Bones, USA · Class II
- Align — SKELETAL DYNAMICS L.L.C. · Class II
- Seitz Solution Radial Head — Kapp Surgical Instrument, Inc. · Class II
- LATITUDE EV™ — TORNIER, INC. · Class II
Cleared under the same submission
K032806 also covers:
- Katalyst™ — Ascension Orthopedics, Inc.
- Katalyst™ Bipolar Radial Head System — Ascension Orthopedics, Inc.
- Katalyst™ Bipolar Radial Head System — Ascension Orthopedics, Inc.
- Katalyst™ Bipolar Radial Head System — Ascension Orthopedics, Inc.
- Katalyst™ Bipolar Radial Head System — Ascension Orthopedics, Inc.
- Katalyst™ Bipolar Radial Head System — Ascension Orthopedics, Inc.
- Katalyst™ Bipolar Radial Head System — Ascension Orthopedics, Inc.
- Katalyst™ Bipolar Radial Head System — Ascension Orthopedics, Inc.
- Katalyst™ Bipolar Radial Head System — Ascension Orthopedics, Inc.
- Katalyst Biopolar Radial Head System — Smith & Nephew, Inc.
- Katalyst Biopolar Radial Head System — Smith & Nephew, Inc.
- Katalyst Biopolar Radial Head System — 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
- Ascension Orthopedics, Inc.
Sources (1)
- FDA UDI 357f21c9-54eb-475a-878c-a7e379b1aede 39 fields · synced Jun 20, 2026