# K203375: OVOMotion Reverse Shoulder Arthroplasty System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrosurface, Inc.
- Decided: Jun 24, 2021 after 220 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K911686 (1991). 119 ancestors in all.
No later device cites it as a predicate yet.
1 of 120 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183039: ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA), Stryker GmbH (2019) Summary page 4.

## Indications for use
The OVOMotion Reverse Shoulder Arthroplasty System is intended for primary total shoulder replacement in a reverse shoulder configuration. The device is indicated for a patient with painful, disabling joint disease of the shoulder resulting from degenerative arthritis or rheumatoid arthritis. The humeral head and neck and glenoid vault should be of sufficient bone stock to support loading. The patient’s joint must have gross rotator cuff deficiency, a functional deltoid muscle and be anatomically and structurally suited to receive the selected implants. Glenoid Baseplate components are intended for cementless use with the addition of screw fixation. The Humeral Stem components are intended for both cemented and cementless use.

Source page: https://510kreport.com/device/K203375
Methodology: https://510kreport.com/methodology