# K030237: Kapp Custom Radial Head Elbow Implant

- Pathway: 510(k) (Traditional)
- Applicant: Kapp Surgical Instrument, Inc.
- Decided: Aug 29, 2003 after 218 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.
No later device cites it as a predicate yet.
0 of 1 device 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 Radial Head Implant: named in the summary without a submission number
- (no number) Wright Medical Metallic Radial Head Implants: named in the summary without a submission number

## Indications for use
The KAPP Radial Elbow Implant is intended to be used for: replacement of the proximal end of the radius: Replacement of the radial head for degenerative, or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radio-humeral and or proximal radio-ulnar joint with either joint destruction or subluxation visible on x-ray and or resislmce to conservative treatment; Primary replaccnent after fracture of the radial head; Symptomatic sequelae after radial head resection; Revision followii ig failed radial head arthroplasty The device is in:ended for custom single use with bone cement

Source page: https://510kreport.com/device/K030237
Methodology: https://510kreport.com/methodology