# K011819: Radial Head Implant

- Pathway: 510(k) (Special)
- Applicant: Avanta Orthopaedics, Inc.
- Decided: Jun 19, 2001 after 8 days
- Product code: KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3170
- Recalls of this device: 1 (0 Class I)
- 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) Wright Medical Swanson Titanium Radial Head Implant: named in the summary without a submission number

## Most influential descendants
- K060038: Sbi Radio-Capitellar Implant (2006), 0 descendants of its own

## Recalls of this device
- Sep 6, 2013 · Class II · Z-0098-2014: The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box.

## Indications for use
Avanta Orthopaedics Radial Head implant is intended 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 radiohumeral and or proximal radio-ulnar joint with: joint destruction or subluxation visible on x-ray resistance to conservative treatment Primary replacement after fracture of the radial head Symptomatic sequelae after radial head resection

Source page: https://510kreport.com/device/K011819
Methodology: https://510kreport.com/methodology