Cleared Traditional

K171768 - Trident® II Acetabular System

K171768 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 Traditional 510(k) pathway after a 110-day FDA review.

K171768 · Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · Orthopedic device
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Oct 2017
Decision
110d
Days
Class 2
Risk

K171768 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 2, 2017 after a review of 110 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 - K171768

510(k) Number K171768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2017
Decision Date October 02, 2017
Days to Decision 110 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
12d faster than avg
Panel avg: 122d · This submission: 110d
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 K171768.
UTS Stem
K172251 · United Orthopedic Corporation · Oct 2017
Bencox Mirabo Cup System
K172806 · Corentec Co., Ltd. · Oct 2017
Smith & Nephew, Inc. ANTHOLOGY™ AFIT Hip Stem
K172684 · Smith & Nephew, Inc. · Oct 2017
iNSitu Total Hip System
K172501 · Theken Companies, LLC · Sep 2017
Klassic HD® Hip System
K171962 · Total Joint Othopedics, Inc. · Jul 2017
U2 Femoral Head
K162957 · United Orthopedic Corporation · Jul 2017