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510(k) K252418

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2025
Date Received
August 1, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device Class
Class II
Regulation Number
888.3660
Review Panel
OR
Submission Type

Other clearances by Catalyst Orthoscience, Inc.

  • K234105 — Catalyst F1x Shoulder System (April 5, 2024)
  • 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 KWS

  • K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 0 (October 29, 2025)
  • K241292 — MyShoulder Planner (5.3SSWPL) (January 30, 2025)
  • K241878 — Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral Sys (December 6, 2024)
  • K241609 — Tornier Humeral Reconstruction System (Tornier HRS) (September 10, 2024)
  • K230513 — Arthrex Univers Apex OptiFit Humeral Stem (September 26, 2023)
  • K222592 — AltiVate® Anatomic Shoulder AG e+™ with Markers (June 23, 2023)
  • K230572 — AETOS Shoulder System (June 7, 2023)
  • K220847 — AETOS Shoulder System (January 3, 2023)
  • K222317 — Catalyst EA Convertible Stemmed Shoulder (November 10, 2022)
  • K213387 — AltiVate® Anatomic Shoulder AG e+™ with Markers (July 7, 2022)