Home / 510(k) Clearances / K223933

510(k) K223933

Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws by Exactech, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2023
Date Received
December 30, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Exactech, Inc.

  • K250713 — Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implant (December 1, 2025)
  • 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)
  • K223833 — Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays (September 14, 2023)
  • K232002 — Vantage® Total Ankle System (September 11, 2023)
  • K223252 — TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas (July 17, 2023)

Other clearances for product code HRS

  • K253906 — Xpert Hand (March 11, 2026)
  • K260069 — DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System (March 9, 2026)
  • K260353 — Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button (March 3, 2026)
  • K254054 — VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System (March 2, 2026)
  • K254249 — HKT Anatomical Locking Trauma System (February 27, 2026)
  • K252166 — RIB LINK™ Fixation System (February 26, 2026)
  • K253660 — KLS Martin Pure Pectus System (February 20, 2026)
  • K251732 — Wrist Fracture System (February 12, 2026)
  • K253713 — Arthrex Variable Angle (VA) Proximal Tibia Plating System (January 21, 2026)
  • K254002 — TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13 (January 15, 2026)