# K191811: Catalyst OrthoScience CSR Shoulder System

- Pathway: 510(k) (Special)
- Applicant: Catalyst Orthoscience, Inc.
- Decided: Sep 11, 2019 after 68 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: 13 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)
- K173812: Catalyst CSR 3 Peg Glenoids, Catalyst Orthoscience, Inc. (2018) Summary page 4.
- K121220: Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/Right, Exactech, Inc. (2012) Summary page 4.
- K981487: Depuy Global Shoulder Glenoid, DePuy Orthopaedics, Inc. (1998) Summary page 4.

## 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 The Catalyst CSR humeral and glenoid implants are intended for cemented use. The Catalyst CSR Press-Fit humeral implants are intended for uncemented or cemented use.

Source page: https://510kreport.com/device/K191811
Methodology: https://510kreport.com/methodology