# K252418: Catalyst F1x Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Catalyst Orthoscience, Inc.
- Decided: Nov 6, 2025 after 97 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- 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: 17 generations back to K911686 (1991). 189 ancestors in all.
No later device cites it as a predicate yet.
1 of 190 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222317: Catalyst EA Convertible Stemmed Shoulder, Catalyst Orthoscience, Inc. (2022) Summary page 5.

## Indications for use
The Catalyst F1x Shoulder System is intended for use as a replacement of shoulder joints in anatomic or reverse arthroplasty. Should the need arise for a conversion from an anatomic total shoulder to a reverse total shoulder, the humeral stem can remain in place, while the articulating surfaces are exchanged. ANATOMIC TOTAL SHOULDER OR HEMI-SHOULDER The Catalyst F1x 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 F1x 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 REVERSE TOTAL SHOULDER The Catalyst F1x 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 after tumor resection; • 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 Catalyst F1x press-fit stems are intended for cementless press-fit applications. The Catalyst F1x cemented stems are intended for cemented fixation. The Catalyst F1x stem is compatible with the implants from the Catalyst CSR System, Catalyst EA Convertible Shoulder System and R1 Shoulder Systems.

Source page: https://510kreport.com/device/K252418
Methodology: https://510kreport.com/methodology