Cleared Traditional

Trivicta? Hip Stem

K233758 · Ortho Development Corp. · Orthopedic

Mar 2024

Decision

105d

Days

Class 2

Risk

About This 510(k) Submission

K233758 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 March 8, 2024, 105 days after receiving the submission on November 24, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K233758 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 24, 2023
Decision Date	March 08, 2024
Days to Decision	105 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