Home / 510(k) Clearances / K120599

510(k) K120599

DEPUY M-SPEC 36MM FEMORAL HEADS by Depuy Orthopaedics — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2013
Date Received
February 28, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type

Other clearances by Depuy Orthopaedics

  • 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)
  • K193398 — Summit DuoFix HA Coating (February 4, 2020)
  • K192919 — Pinnacle Duofix HA Acetabular Cup Prosthesis (November 26, 2019)
  • K192946 — DePuy Corail AMT Hip Prosthesis (November 26, 2019)

Other clearances for product code LPH

  • K252623 — G7® Revision Acetabular System (February 4, 2026)
  • K251043 — Mpact 3D Metal Implants Extension – DMLS Technology (January 28, 2026)
  • K252067 — Velora Acetabular System (December 5, 2025)
  • K252846 — TaperSet™ Hip System (November 20, 2025)
  • K251833 — EMPOWR Acetabular® Liner Extension (November 12, 2025)
  • K251718 — ArTT Augments and Buttresses and Bone Screws (August 29, 2025)
  • K250989 — Stryker and Serf hip devices (July 25, 2025)
  • K243456 — ONVOY™ Acetabular System (June 6, 2025)
  • K242744 — Trinity EVO Acetabular Shell (June 5, 2025)
  • K242232 — Mpact 3D Metal Augments II (April 23, 2025)