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510(k) K211991

Catalyst R1 Reverse Shoulder System by Catalyst Orthoscience, Inc. — Product Code PHX

K211991 is an FDA 510(k) premarket notification submitted by Catalyst Orthoscience, Inc. for the device "Catalyst R1 Reverse Shoulder System". The FDA issued a decision of Substantially Equivalent on July 28, 2021. The device falls under product code PHX (Shoulder Prosthesis, Reverse Configuration), a Class II device regulated under 21 CFR 888.3660. Catalyst Orthoscience, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2021
Date Received
June 28, 2021
Clearance Type
Special
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)
  • 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)
  • 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

  • K260556 — Veritas Shoulder System (July 1, 2026)
  • K261683 — Augment Off-Axis Instrument System (June 16, 2026)
  • K260102 — Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid (June 12, 2026)
  • K261016 — MSS - Humeral reverse liners extension (June 10, 2026)
  • K253992 — Veritas Reverse Total Shoulder System (May 7, 2026)
  • K252404 — Comprehensive Reverse Shoulder - HA Glenosphere Baseplates (April 15, 2026)
  • K260583 — Equinoxe® Shoulder System (April 14, 2026)
  • K254128 — InSet Reverse Total Shoulder System (April 13, 2026)
  • K253674 — Blueprint Patient-Specific Instrumentation (April 3, 2026)
  • K253624 — INHANCE™ Reverse Shoulder System (March 11, 2026)

FDA data resources