# K041858: Acumed Anatomic Radial Head System

- Pathway: 510(k) (Traditional)
- Applicant: Acumed, LLC
- Decided: Oct 5, 2004 after 88 days
- Product code: KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation 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)
- K002644: Radial Head Implant, Avanta Orthopaedics, Inc. (2000) Summary page 1.
- K991915: Modular Radial Head, Wrightmedicaltechnologyinc (1999) Summary page 1.

## Most influential descendants
- K131845: Acumed Anatomic Radial Head System, Acumed Anatomic Radial Head Long Stems, Acumed Arh Slide-Loc (2013), 0 descendants of its own
- K092721: Align Radial Head System (2010), 0 descendants of its own

## Indications for use
The Acumed Anatomic Radial Head System and accessories are designed specifically for: 1. 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: joint destruction and/or subluxation, 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

Source page: https://510kreport.com/device/K041858
Methodology: https://510kreport.com/methodology