Cleared Traditional

Trinity EVO Acetabular Shell

K242744 · Corin U.S.A. Limited · Orthopedic

Jun 2025

Decision

267d

Days

Class 2

Risk

About This 510(k) Submission

K242744 is an FDA 510(k) clearance for the Trinity EVO Acetabular Shell, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Corin U.S.A. Limited (Tampa, US). The FDA issued a Cleared decision on June 5, 2025, 267 days after receiving the submission on September 11, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K242744 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 11, 2024
Decision Date	June 05, 2025
Days to Decision	267 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LPH — Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3358