# K991915: Modular Radial Head

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Sep 3, 1999 after 88 days
- Product code: KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3170
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
37 later devices descend from it; 9 cite it directly.
0 of 38 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) Metallic Radial Head Implant: 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

## Recalls of this device
- Aug 3, 2022 · Class II · Z-0005-2023: The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem 9.5mm +4 con
- Aug 3, 2022 · Class II · Z-0006-2023: The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem 9.5mm +4 con
- Aug 26, 2020 · Class II · Z-2989-2020: Lack of sterility assurance

## Indications for use
Use of the Modular Radial Head Implants may be considered for: Replacement of the radial head for degenerative or post-traumatic disabilities presenting paip, crepitation, and decreased motion at the redio-humeral and/or proximal radio-uloar joint with: a. joint destruction and/or subluxation visible on x-ray; and/or b. resistance to conservative treatment., Primary replacement after fracture of the radial bead. Symptomatic sequelae after radial head resection. Revision following failed radial head arthroplasty.

Source page: https://510kreport.com/device/K991915
Methodology: https://510kreport.com/methodology