# K173964: OVOMotion Shoulder Arthroplasty System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrosurface, Inc.
- Decided: Apr 18, 2018 after 110 days
- Product code: HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K920362 (1993). 85 ancestors in all.
No later device cites it as a predicate yet.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142942: HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System, Arthrosurface, Inc. (2014) Summary page 5.
- K152825: Catalyst CSR Shoulder System, Catalyst Orthoscience, LLC (2016) Summary page 5.

## Indications for use
For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck and glenoid vault should be of sufficient bone stock to support loading. The rotator cuff should be intact or reconstructable. The device is a single use implant intended to be used for hemiarthroplasty or in conjunction with the Arthrosurface glenoid component for total shoulder arthroplasty. Both humeral and glenoid components of the OVOMotion™ Shoulder Arthroplasty System are intended for cemented use only.

Source page: https://510kreport.com/device/K173964
Methodology: https://510kreport.com/methodology