# K182500: Catalyst CSR Press-Fit Humeral Components

- Pathway: 510(k) (Traditional)
- Applicant: Catalyst Orthoscience, Inc.
- Decided: Jan 11, 2019 after 121 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.
2 later devices descend from it; 1 cites it directly.
0 of 88 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.
- K181287: Catalyst CSR Shoulder System, Catalyst Orthoscience, Inc. (2018) Summary page 4.
- K131298: Exactech Equinoxe Resurfacing Humeral Head System, Exactech, Inc. (2013) Summary page 4.
- K003044: Copeland Resurfacing Heads, Biomet, Inc. (2000) Summary page 4.

## Most influential descendants
- K222317: Catalyst EA Convertible Stemmed Shoulder (2022), 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 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/K182500
Methodology: https://510kreport.com/methodology