# K982288: Radial Head Implant

- Pathway: 510(k) (Traditional)
- Applicant: Avanta Orthopaedics, Inc.
- Decided: Sep 8, 1998 after 70 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
Longest line of descent: 1 generation back to K944507 (1995). 1 ancestor in all.
27 later devices descend from it; 5 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944507: Metallic Radial Head Implants, Wrightmedicaltechnologyinc (1995) Summary page 1.
- (no number) Dow Corning Corporation Silastic Swanson Radial Head Implant: named in the summary without a submission number

## Most influential descendants
- K023604: Modification to Radial Head Implant (2002), 19 descendants of its own
- K060438: RHS (2006), 18 descendants of its own
- K130533: Salto Talaris Total Ankle Prosthesis, RHS (2013), 16 descendants of its own
- K153452: Salto XT, Salto Talaris (2016), 15 descendants of its own
- K192994: Paragon 28 APEX 3D Total Ankle Replacement System (2020), 8 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/K982288
Methodology: https://510kreport.com/methodology