# K173812: Catalyst CSR 3 Peg Glenoids

- Pathway: 510(k) (Traditional)
- Applicant: Catalyst Orthoscience, Inc.
- Decided: Mar 9, 2018 after 84 days
- Product code: KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3650
- 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). 84 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152825: Catalyst CSR Shoulder System, Catalyst Orthoscience, LLC (2016) Summary page 4.
- K981487: Depuy Global Shoulder Glenoid, DePuy Orthopaedics, Inc. (1998) Summary page 4.
- K150583: Aequalis PerFORM+ Shoulder System, Tornier, Inc. (2015) Summary page 4.

## Most influential descendants
- K191811: Catalyst OrthoScience CSR Shoulder System (2019), 0 descendants of its own

## Indications for use
The Catalyst CSR Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where hemi- or total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment. The Catalyst CSR Shoulder System is intended for use in patients with the following conditions where the humeral head, neck and glenoid vault are of sufficient bone stock and the rotator cuff is intact or reconstructable. • Osteoarthritis • Avascular Necrosis • Rheumatoid Arthritis • Post-traumatic Arthritis • Correction of functional deformity Both components of the Catalyst CSR Shoulder System are intended for cemented use only.

Source page: https://510kreport.com/device/K173812
Methodology: https://510kreport.com/methodology