Home / 510(k) Clearances / K240278

510(k) K240278

Full Wedge Lateralized and Augmented Baseplates by Fx Shoulder USA, Inc. — Product Code PHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2024
Date Received
February 1, 2024
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 Fx Shoulder USA, Inc.

  • K223801 — FX V135(TM) Shoulder Prosthesis (June 5, 2023)
  • K222936 — Humeris® 135 Shoulder System (November 7, 2022)
  • K213117 — FX V135 Shoulder Prosthesis (June 7, 2022)
  • K210790 — Lateralized and Augmented Baseplates (August 25, 2021)
  • K201391 — Easytech® Anatomical Shoulder System (February 16, 2021)
  • K191698 — TiN Coated Humeral Head (July 16, 2020)
  • K191146 — Humelock TiN Coated Glenosphere (July 15, 2020)
  • K193394 — Humeral Cup Stability & Humeral Cup 135/145o Stability (April 29, 2020)
  • K192799 — Glenoid Baseplate with Screw (February 21, 2020)
  • K192206 — 32mm Glenosphere and Humeral Cup (October 8, 2019)

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)
  • K252567 — AltiVate Reverse® ADLC Glenosphere (January 15, 2026)
  • K252516 — N22 EZ 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)