510(k) K234105

Catalyst F1x Shoulder System by Catalyst Orthoscience, Inc. — Product Code PHX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 5, 2024
Date Received: December 26, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Shoulder Prosthesis, Reverse Configuration
Device Class: Class II
Regulation Number: 888.3660
Review Panel: OR
Submission Type

Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint.

Other clearances by Catalyst Orthoscience, Inc.

K252418 — Catalyst F1x Shoulder System (November 6, 2025)
K232583 — Catalyst R1 Reverse Shoulder System (September 20, 2023)
K223655 — Catalyst R1 Reverse Shoulder System (May 9, 2023)
K222317 — Catalyst EA Convertible Stemmed Shoulder (November 10, 2022)
K213349 — Catalyst R1 Reverse Shoulder System (June 23, 2022)
K211991 — Catalyst R1 Reverse Shoulder System (July 28, 2021)
K202611 — Catalyst OrthoScience R1 Reverse Shoulder System (February 12, 2021)
K191811 — Catalyst OrthoScience CSR Shoulder System (September 11, 2019)
K182500 — Catalyst CSR Press-Fit Humeral Components (January 11, 2019)
K181287 — Catalyst CSR Shoulder System (July 12, 2018)

Other clearances for product code PHX

K253624 — INHANCE Reverse Shoulder System (March 11, 2026)
K250644 — MSS - Monobloc stem (February 3, 2026)
K252352 — SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System (January 22, 2026)
K252516 — N22 EZ Glenosphere (January 15, 2026)
K252567 — AltiVate Reverse® ADLC Glenosphere (January 15, 2026)
K254003 — JARVIS Metaphyseal Stem (January 9, 2026)
K252788 — Tornier Perform Reversed Monopost Glenoid (Perform Mono) (January 8, 2026)
K250338 — MSS - Humeral reverse liners extension (October 31, 2025)
K253345 — JARVIS Diaphyseal Stem Standard (October 29, 2025)
K252221 — Inset Reverse Total Shoulder System (September 26, 2025)