Cleared Special

K191358 - Trident II Acetabular System

K191358 is an FDA 510(k) clearance for Trident II Acetabular System, 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 Special 510(k) pathway after a 156-day FDA review.

K191358 · Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2019
Decision
156d
Days
Class 2
Risk

K191358 is an FDA 510(k) clearance for the Trident II Acetabular System. 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 24, 2019 after a review of 156 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K191358

510(k) Number K191358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2019
Decision Date October 24, 2019
Days to Decision 156 days
Submission Type Special
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
34d slower than avg
Panel avg: 122d · This submission: 156d
Pathway characteristics
Modification to existing cleared device.

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 564
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K191358.
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K191358 · Trident II Acetabular System
Download PDF FDA Summary Howmedica Osteonics C…