# K002644: Radial Head Implant

- Pathway: 510(k) (Traditional)
- Applicant: Avanta Orthopaedics, Inc.
- Decided: Nov 20, 2000 after 88 days
- Product code: KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3170
- Recalls of this device: 21 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
27 later devices descend from it; 5 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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
- K023604: Modification to Radial Head Implant (2002), 19 descendants of its own
- K060438: RHS (2006), 18 descendants of its own

## Recalls of this device
- Oct 24, 2017 · Class II · Z-2685-2018: 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-2680-2018: 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-2723-2018: 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-2727-2018: 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-2726-2018: 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-2684-2018: 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-2681-2018: 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-2724-2018: 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-2731-2018: 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-2678-2018: 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-2730-2018: 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-2683-2018: 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-2682-2018: 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-2722-2018: 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-2729-2018: 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-2728-2018: 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-2679-2018: 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-2677-2018: 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-2725-2018: 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-2732-2018: 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.
- Sep 6, 2013 · Class II · Z-0098-2014: The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box.

Source page: https://510kreport.com/device/K002644
Methodology: https://510kreport.com/methodology