Trivicta® Hip Stem— 510(k) K251052

Name: FDA 510(k) clearance K251052
Creator: U.S. Food and Drug Administration
Published: 2025-05-22

Substantially Equivalent

Ortho Development Corp.

FDA 510(k) clearance K251052 for Trivicta® Hip Stem, Substantially Equivalent on 2025-05-22. Applicant: Ortho Development Corp.. Device class: 2.

Clearance details

Applicant: Ortho Development Corp.
Product code: Code MEH
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 2025-04-03
Decision date: 2025-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Draper, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MEH

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K261576 — Icona Hip Stem2026-08-10
K250375 — Allure Hip Stem and Intramedullary Plugs2025-11-05
K251166 — Mfinity Femoral System2025-06-13
K242315 — Resolve Modular Revision Hip Stem2025-05-01
K243839 — Alteon® HA Femoral Stems2025-03-10

More clearances from Ortho Development Corp.

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K253161 — Balanced Knee System TriMax Porous Femoral Components2025-12-19
K242984 — BKS Revision System2024-10-25
K242833 — Legend® Acetabular Shell2024-10-11
K233758 — Trivicta Hip Stem2024-03-08
K142146 — IBIS PEDICLE SCREW SYSTEM2014-12-11

Adverse events under product code MEH

product code MEH

Injury: 2,021
Total: 2,021

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.