# K152825: Catalyst CSR Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Catalyst Orthoscience, LLC
- Decided: May 11, 2016 after 225 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: 11 generations back to K920362 (1993). 83 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 91 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131298: Exactech Equinoxe Resurfacing Humeral Head System, Exactech, Inc. (2013) Summary page 4.
- K023096: Contoured Articular Prosthesis (Cap) Humeral Head Resurfacing System, Std Mfg., Inc. (2003) Summary page 4.
- K091196: GRS Glenoid Resurfacing System, Arthrosurface, Inc. (2009) Summary page 4.
- K031971: Global Cap Resurfacing Replacement Shoulder, DePuy Orthopaedics, Inc. (2003) Summary page 4.
- K981487: Depuy Global Shoulder Glenoid, DePuy Orthopaedics, Inc. (1998) Summary page 4.
- K003044: Copeland Resurfacing Heads, Biomet, Inc. (2000) Summary page 4.
- K150583: Aequalis PerFORM+ Shoulder System, Tornier, Inc. (2015) Summary page 4.

## Most influential descendants
- K181287: Catalyst CSR Shoulder System (2018), 3 descendants of its own
- K182500: Catalyst CSR Press-Fit Humeral Components (2019), 2 descendants of its own
- K222317: Catalyst EA Convertible Stemmed Shoulder (2022), 1 descendant of its own
- K173812: Catalyst CSR 3 Peg Glenoids (2018), 1 descendant of its own
- K252418: Catalyst F1x Shoulder System (2025), 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/K152825
Methodology: https://510kreport.com/methodology