# K131845: Acumed Anatomic Radial Head System, Acumed Anatomic Radial Head Long Stems, Acumed Arh Slide-Loc

- Pathway: 510(k) (Traditional)
- Applicant: Acumed, LLC
- Decided: Sep 30, 2013 after 101 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041858: Acumed Anatomic Radial Head System, Acumed, LLC (2004) Summary page 1.

## Recalls of this device
- Apr 20, 2017 · Class II · Z-2197-2017: The firm initiates a voluntary removal and discontinue marketing of Slide-Loc Anatomic Radial Head System based on its performance in the market. The firm received product complaints regarding instrum

## Indications for use
The Acumed Anatomic Radial Head System, the Acumed Anatomic Radial Head Long Stems, the Acumed ARH Slide-LocTh 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 radiohumeral 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. The device is intended to be press fit or cemented.

Source page: https://510kreport.com/device/K131845
Methodology: https://510kreport.com/methodology