Cleared Traditional

K161569 - Trident II Tritanium Acetabular Shells ...

K161569 is the FDA 510(k) clearance for Trident II Tritanium Acetabular Shells ... by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. It is a Class 2 Orthopedic device (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
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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

Submission Details

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
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.

Device Classification

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 442
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