Home / 510(k) Clearances / K193398

510(k) K193398

Summit DuoFix HA Coating by DePuy Orthopaedics, Inc. — Product Code MEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2020
Date Received
December 6, 2019
Clearance Type
Special
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 DePuy Orthopaedics, Inc.

  • K231503 — CUPTIMIZE™ Advanced (August 22, 2023)
  • K213839 — DePuy Corail AMT Hip Prosthesis (January 6, 2022)
  • K210167 — DELTA XTEND Reverse Shoulder System (February 19, 2021)
  • K203167 — DePuy Corail AMT Hip Prosthesis (November 19, 2020)
  • K202472 — ACTIS Duofix Hip Prosthesis (October 21, 2020)
  • K201347 — DePuy ATTUNE™ Total Knee System (June 18, 2020)
  • K193540 — TRUMATCH Personalized Solutions (June 16, 2020)
  • K192919 — Pinnacle Duofix HA Acetabular Cup Prosthesis (November 26, 2019)
  • K192946 — DePuy Corail AMT Hip Prosthesis (November 26, 2019)
  • K182301 — PFC SIGMA Knee System (November 8, 2019)

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)
  • K243839 — Alteon® HA Femoral Stems (March 10, 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)