# K984290: Implex Radial Head Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Implex Corp.
- Decided: Jun 1, 1999 after 182 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.
26 later devices descend from it; 4 cite it directly.
0 of 27 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 Technology, Metallic Radial Heads: named in the summary without a submission number
- (no number) Avanta Orthopedics, Avanta RH™: named in the summary without a submission number

## Most influential descendants
- K012551: Liverpool Radial Head Replacement Device (2002), 23 descendants of its own
- K040611: Modular Radial Head Replacement Device (2004), 22 descendants of its own
- K051385: Explor Modular Radial Head Replacement Device (2005), 21 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

## Indications for use
For Cemented Use Only. 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: Joint destruction and/or subluxation. Resistance to conservative treatment. Primary replacement after fracture of the radial head. Symptomatic sequelae after radial head resection. Revision following failed radial head arthroplasty.

Source page: https://510kreport.com/device/K984290
Methodology: https://510kreport.com/methodology