Cleared Traditional

Trident? II Tritanium? Acetabular Shells and 6.5 mm Low Profile Hex Screws

K161569 · Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · Orthopedic

Oct 2016

Decision

129d

Days

Class 2

Risk

About This 510(k) Submission

K161569 is an FDA 510(k) clearance for the Trident? II Tritanium? Acetabular Shells and 6.5 mm Low Profile Hex Screws, 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 October 14, 2016, 129 days after receiving the submission on June 7, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K161569 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 07, 2016
Decision Date	October 14, 2016
Days to Decision	129 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