# K023604: Modification to Radial Head Implant

- Pathway: 510(k) (Special)
- Applicant: Avanta Orthopaedics, Inc.
- Decided: Nov 27, 2002 after 30 days
- Product code: KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3170
- Recalls of this device: 18 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K944507 (1995). 3 ancestors in all.
19 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982288: Radial Head Implant, Avanta Orthopaedics, Inc. (1998) Summary page 1.
- K002644: Radial Head Implant, Avanta Orthopaedics, Inc. (2000) Summary page 1.

## Most influential descendants
- 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
- K210390: Apex 3D Total Ankle Replacement System (2021), 2 descendants of its own

## Recalls of this device
- Oct 24, 2017 · Class II · Z-2686-2018: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
- Oct 24, 2017 · Class II · Z-2715-2018: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
- Oct 24, 2017 · Class II · Z-2719-2018: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
- Oct 24, 2017 · Class II · Z-2713-2018: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
- Oct 24, 2017 · Class II · Z-2714-2018: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
- Oct 24, 2017 · Class II · Z-2687-2018: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
- Oct 24, 2017 · Class II · Z-2689-2018: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
- Oct 24, 2017 · Class II · Z-2691-2018: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
- Oct 24, 2017 · Class II · Z-2692-2018: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
- Oct 24, 2017 · Class II · Z-2718-2018: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
- Oct 24, 2017 · Class II · Z-2717-2018: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
- Oct 24, 2017 · Class II · Z-2712-2018: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
- Oct 24, 2017 · Class II · Z-2721-2018: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
- Oct 24, 2017 · Class II · Z-2716-2018: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
- Oct 24, 2017 · Class II · Z-2720-2018: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
- Oct 24, 2017 · Class II · Z-2711-2018: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
- Oct 24, 2017 · Class II · Z-2690-2018: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
- Oct 24, 2017 · Class II · Z-2688-2018: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.

## 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/K023604
Methodology: https://510kreport.com/methodology