Cleared Traditional

Trivicta? Hip Stem

K251052 · Ortho Development Corp. · Orthopedic

May 2025

Decision

49d

Days

Class 2

Risk

About This 510(k) Submission

K251052 is an FDA 510(k) clearance for the Trivicta? Hip Stem, a Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (Class II — Special Controls, product code MEH), submitted by Ortho Development Corp. (Draper, US). The FDA issued a Cleared decision on May 22, 2025, 49 days after receiving the submission on April 3, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K251052 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 03, 2025
Decision Date	May 22, 2025
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MEH — Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353