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510(k) K193098

Exactech® Equinoxe® Reverse Shoulder Glenospheres by Exactech, Inc. — Product Code PHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2020
Date Received
November 7, 2019
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 Exactech, Inc.

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  • K243448 — Equinoxe® Shoulder System (August 1, 2025)
  • K243275 — Equinoxe® Scapula Fracture System (June 26, 2025)
  • K243839 — Alteon® HA Femoral Stems (March 10, 2025)
  • K240393 — Exactech® TRULIANT® Knee System (October 3, 2024)
  • K233482 — Equinoxe® Central Screw Baseplate System (July 18, 2024)
  • K230717 — Exactech® Vantage® Total Ankle System (October 12, 2023)
  • K223933 — Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws (September 25, 2023)
  • K223833 — Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays (September 14, 2023)
  • K232002 — Vantage® Total Ankle System (September 11, 2023)

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)