# K223655: Catalyst R1 Reverse Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Catalyst Orthoscience, Inc.
- Decided: May 9, 2023 after 154 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: 19 generations back to K911686 (1991). 177 ancestors in all.
No later device cites it as a predicate yet.
1 of 178 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202611: Catalyst OrthoScience R1 Reverse Shoulder System, Catalyst Orthoscience, Inc. (2021) Summary page 4.
- K211991: Catalyst R1 Reverse Shoulder System, Catalyst Orthoscience, Inc. (2021) Summary page 4.
- K213349: Catalyst R1 Reverse Shoulder System, Catalyst Orthoscience, Inc. (2022) Summary page 4.

## Indications for use
The Catalyst R1 Reverse Shoulder System is a reverse total shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to: * Severe arthropathy with a grossly deficient rotator cuff: » Previously failed joint replacement with a grossly deficient rotator cuff; * Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction afier tumor resection; * Bone defect in proximal humerus; * Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/ or glenoid; * Inflammatory arthritis including rheumatoid arthritis; * Correction of functional deformity The humeral stems are intended for cemented or uncemented applications. The glenoid baseplate is intended for uncemented use with the addition of screws for fixation.

Source page: https://510kreport.com/device/K223655
Methodology: https://510kreport.com/methodology