Cleared Special

DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System

K232556 · Depuy Ireland UC · Orthopedic

Sep 2023

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K232556 is an FDA 510(k) clearance for the DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Depuy Ireland UC (Cork, IE). The FDA issued a Cleared decision on September 20, 2023, 28 days after receiving the submission on August 23, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K232556 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 23, 2023
Decision Date	September 20, 2023
Days to Decision	28 days
Submission Type	Special
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