# K222317: Catalyst EA Convertible Stemmed Shoulder

- Pathway: 510(k) (Traditional)
- Applicant: Catalyst Orthoscience, Inc.
- Decided: Nov 10, 2022 after 100 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: 16 generations back to K911686 (1991). 188 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 190 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172351: AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert, Encore Medical L.P. (2017) Summary page 5.
- K182500: Catalyst CSR Press-Fit Humeral Components, Catalyst Orthoscience, Inc. (2019) Summary page 5.

## Most influential descendants
- K252418: Catalyst F1x Shoulder System (2025), 0 descendants of its own

## Indications for use
The Catalyst EA Convertible Stemmed Shoulder 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 EA Convertible Stemmed Shoulder 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 EA Convertible Stemmed Shoulder 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 3-Peg glenoid implants are intended for cemented use only. The Catalyst R1 Reverse Shoulder humeral stems are intended for cemented or uncemented applications. Reverse Total Shoulder The Catalyst EA Convertible Stemmed Shoulder 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; • Bone defect in proximal humerus; • 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 R1 Shoulder humeral stems are intended for uncemented or cemented applications. The glenoid baseplate is intended for uncemented use with the addition of screws for fixation.

Source page: https://510kreport.com/device/K222317
Methodology: https://510kreport.com/methodology