# K032806: Katalyst Radial Head Implant

- Pathway: 510(k) (Traditional)
- Applicant: Kinetikos Medical, Inc.
- Decided: Apr 16, 2004 after 220 days
- Product code: KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Avanta R Head Recon Radial Implant System: named in the summary without a submission number
- (no number) Tornier BiPolar Radial Head Prosthesis: named in the summary without a submission number
- (no number) Biomet Liverpool Radial Head Replacement: named in the summary without a submission number
- (no number) Wright Medical Evolve Modular Radial Head: named in the summary without a submission number

## Most influential descendants
- K213827: TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst) (2022), 0 descendants of its own

## Indications for use
The KMI Katalyst Radial Head system is generally indicated for use in radial head replacement arthroplasty. Use of the implant is contraindicated in those cases where complete vascular necrosis had rendered bone stock inadequate.

Source page: https://510kreport.com/device/K032806
Methodology: https://510kreport.com/methodology