Cleared Traditional

K161569 - Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws

K161569 is an FDA 510(k) clearance for Trident II Tritanium Acetabular Shells ..., manufactured by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K161569 · Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2016
Decision
129d
Days
Class 2
Risk

K161569 is an FDA 510(k) clearance for the Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics (Mahwah, US). The FDA issued a Cleared decision on October 14, 2016 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics devices

FDA 510(k) Submission Details - K161569

510(k) Number K161569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 122d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPH Device Classification - Class 2, Special Controls

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 537
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K161569.
Bencox M Stem Lateralized & Bencox Mirabo Cup System
K162127 · Corentec Co., Ltd. · Dec 2016
Klassic HD Hip System
K161073 · Total Joint Othopedics, Inc. · Oct 2016
iNSitu Total Hip System
K161184 · Theken Companies, LLC · Oct 2016
The Progressive Orthopaedic Total Hip System
K151424 · The Progressive Orthopaedic Company, LLC · Jul 2016
G7 Dual Mobility System, Active Articulation System
K161190 · Biomet, Inc. · May 2016
Stryker Orthopaedics Hip Systems Labeling Update
K153345 · Stryker Orthopaedics · May 2016