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510(k) K193394

Humeral Cup Stability & Humeral Cup 135/145o Stability by Fx Shoulder USA, Inc. — Product Code PHX

K193394 is an FDA 510(k) premarket notification submitted by Fx Shoulder USA, Inc. for the device "Humeral Cup Stability & Humeral Cup 135/145o Stability". The FDA issued a decision of Substantially Equivalent on April 29, 2020. The device falls under product code PHX (Shoulder Prosthesis, Reverse Configuration), a Class II device regulated under 21 CFR 888.3660. Fx Shoulder USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2020
Date Received
December 6, 2019
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.

  • K240278 — Full Wedge Lateralized and Augmented Baseplates (May 15, 2024)
  • 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)
  • K192799 — Glenoid Baseplate with Screw (February 21, 2020)
  • K192206 — 32mm Glenosphere and Humeral Cup (October 8, 2019)

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