Cleared Traditional

Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System

K182468 · Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · Orthopedic

Mar 2019

Decision

190d

Days

Class 2

Risk

About This 510(k) Submission

K182468 is an FDA 510(k) clearance for the Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on March 19, 2019, 190 days after receiving the submission on September 10, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K182468 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 10, 2018
Decision Date	March 19, 2019
Days to Decision	190 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