Cleared Traditional

K153345 - Stryker Orthopaedics Hip Systems Labeling Update

K153345 is an FDA 510(k) clearance for Stryker Orthopaedics Hip Systems Labeli..., manufactured by Stryker Orthopaedics. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K153345 · Stryker Orthopaedics · Orthopedic device
Download Printable Device Report (PDF)
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May 2016
Decision
188d
Days
Class 2
Risk

K153345 is an FDA 510(k) clearance for the Stryker Orthopaedics Hip Systems Labeling Update. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Stryker Orthopaedics (Mahwah, US). The FDA issued a Cleared decision on May 25, 2016 after a review of 188 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. 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 Stryker Orthopaedics devices

FDA 510(k) Submission Details - K153345

510(k) Number K153345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2015
Decision Date May 25, 2016
Days to Decision 188 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
66d slower than avg
Panel avg: 122d · This submission: 188d
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 K153345.
Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws
K161569 · Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 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
Escalade Legend Acetabular Shell
K161080 · Ortho Development Corporation · May 2016
Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug
K152084 · Corentec Co., Ltd. · Apr 2016
ICONACY(TM) I-Hip(TM)
K160266 · Iconacy Orthopedic Implants, LLC · Apr 2016