# K032686: Ascension Modular Radial Head

- Pathway: 510(k) (Traditional)
- Applicant: Ascension Orthopedics, Inc.
- Decided: Oct 22, 2003 after 54 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: 2 generations back to K944507 (1995). 3 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 7 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.
- K991915: Modular Radial Head, Wrightmedicaltechnologyinc (1999) Summary page 1.

## Most influential descendants
- K213827: TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst) (2022), 0 descendants of its own
- K112030: Synthes Radial Head Prosthesis System (2012), 0 descendants of its own
- K102180: Rhead Radial Head Extended Stems (2010), 0 descendants of its own

## Indications for use
The Ascension@Modular Radial Head is intended for: 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 or subluxation visible on x-ray resistance to conservative treatment Primary replacement after fracture of the radial head Symptomatic sequelae after radial head resection Revision following failed radial head arthroplasty

Source page: https://510kreport.com/device/K032686
Methodology: https://510kreport.com/methodology