Home / 510(k) Clearances / K233758

510(k) K233758

Trivicta™ Hip Stem by Ortho Development Corp. — Product Code MEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2024
Date Received
November 24, 2023
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 Ortho Development Corp.

  • K253161 — Balanced Knee System TriMax Porous Femoral Components (December 19, 2025)
  • K251052 — Trivicta® Hip Stem (May 22, 2025)
  • K242984 — BKS Revision System (October 25, 2024)
  • K242833 — Legend® Acetabular Shell (October 11, 2024)
  • K142146 — IBIS PEDICLE SCREW SYSTEM (December 11, 2014)
  • K141001 — ALPINE HIP STEM; ALPINE HA HIP STEM (July 30, 2014)
  • K132697 — ENCOMPASS 10/12 HIP STEM (June 20, 2014)
  • K133386 — OVATION TRIBUTE HIP STEM; OVATION NARROW HIP STEM (March 11, 2014)
  • K133449 — KASM KNEE ARTICULATING SPACER MOLDS (February 18, 2014)
  • K131022 — OVATION 10/12 HIP STEM (October 16, 2013)

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)
  • K231873 — DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip P (January 19, 2024)