Home / 510(k) Clearances / K243839

510(k) K243839

Alteon® HA Femoral Stems by Exactech, Inc. — Product Code MEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2025
Date Received
December 13, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Device Class
Class II
Regulation Number
888.3353
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)
  • 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)
  • K223252 — TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas (July 17, 2023)

Other clearances for product code MEH

  • K250375 — Allure Hip Stem and Intramedullary Plugs (November 5, 2025)
  • K251166 — Mfinity Femoral System (June 13, 2025)
  • K251052 — Trivicta® Hip Stem (May 22, 2025)
  • K242315 — Resolve Modular Revision Hip Stem (May 1, 2025)
  • K243162 — World Liner (November 25, 2024)
  • K241472 — Icona Hip Stem (October 3, 2024)
  • K241875 — TheRay Collared and Collarless Femoral Stem (September 13, 2024)
  • K241690 — Logical Liner; World Liner; World Knee Patella (August 1, 2024)
  • K233758 — Trivicta™ Hip Stem (March 8, 2024)
  • K231873 — DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip P (January 19, 2024)