# K040611: Modular Radial Head Replacement Device

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jun 4, 2004 after 88 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 K984290 (1999). 4 ancestors in all.
22 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012551: Liverpool Radial Head Replacement Device, Biomet, Inc. (2002) Summary page 1.
- K984290: Implex Radial Head Replacement System, Implex Corp. (1999) Summary page 1.
- K002644: Radial Head Implant, Avanta Orthopaedics, Inc. (2000) Summary page 1.
- K991915: Modular Radial Head, Wrightmedicaltechnologyinc (1999) Summary page 1.

## Most influential descendants
- 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
- 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

## Recalls of this device
- Apr 22, 2014 · Class II · Z-1615-2014: This lot of the ExploR Modular Radial Stem may be missing the wedge ramp threads. If the wedge ramp threads are missing from the stem, the likelihood of the set screw loosening from the radial stem in

## Indications for use
The Modular Radial Head Replacement Device is intended for: 1) Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, creptation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: a) Joint destruction and/or subluxation visible on x-ray b) Resistance to conservative treatment 2) Primary replacement after fracture of the radial head 3) Symptomatic sequelae after radial head resection 4) Revision following failed radial head arthroplasty The device is intended for single use with bone cement.

Source page: https://510kreport.com/device/K040611
Methodology: https://510kreport.com/methodology