# K183618: Revolution Radial Head

- Pathway: 510(k) (Traditional)
- Applicant: Ignite Orthopedics, Inc.
- Decided: May 17, 2019 after 142 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: 2 generations back to K991915 (1999). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060731: Evolve Modular Radial Head, Wrightmedicaltechnologyinc (2006) Summary page 4.

## Most influential descendants
- 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
- Apr 7, 2022 · Class II · Z-1072-2022: DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis.

## Indications for use
The Ignite Orthopedics Revolution Radial Head is indicated 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: o joint destruction and/or subluxation visible on x-ray; and/or o 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/K183618
Methodology: https://510kreport.com/methodology