# K060731: Evolve Modular Radial Head

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Apr 19, 2006 after 30 days
- Product code: KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3170
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K991915 (1999). 1 ancestor in all.
7 later devices descend from it; 5 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991915: Modular Radial Head, Wrightmedicaltechnologyinc (1999) Summary page 1.

## Most influential descendants
- K183618: Revolution Radial Head (2019), 2 descendants of its own
- K192754: Avenger Radial Head System (2020), 1 descendant of its own
- K260624: Arthrex Radial Head Replacement System (2026), 0 descendants of its own
- K233592: BioPoly Radial Head Implant (2024), 0 descendants of its own
- K213563: DePuy Synthes Radial Head Replacement System (2022), 0 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
- Dec 27, 2019 · Class II · Z-1102-2020: Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product.
- Dec 27, 2019 · Class II · Z-1101-2020: Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product.

## Indications for use
Use of the Modular Radial Head Implant may be considered for: · 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: a. joint destruction and/or subluxation visible on x-ray; and/or b. 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/K060731
Methodology: https://510kreport.com/methodology