# K234105: Catalyst F1x Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Catalyst Orthoscience, Inc.
- Decided: Apr 5, 2024 after 101 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- 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: 20 generations back to K911686 (1991). 212 ancestors in all.
No later device cites it as a predicate yet.
1 of 213 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161189: Integra TITAN Reverse Shoulder System, Integra LifeSciences Corporation (2016) Summary page 4.
- K213349: Catalyst R1 Reverse Shoulder System, Catalyst Orthoscience, Inc. (2022) Summary page 4.
- K232583: Catalyst R1 Reverse Shoulder System, Catalyst Orthoscience, Inc. (2023) Summary page 4.
- K202611: Catalyst OrthoScience R1 Reverse Shoulder System, Catalyst Orthoscience, Inc. (2021) Summary page 4.

## Indications for use
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 The 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 R1 Shoulder Systems.

Source page: https://510kreport.com/device/K234105
Methodology: https://510kreport.com/methodology