Cleared Traditional

K153345 - Stryker Orthopaedics Hip Systems Labeli...

K153345 is the FDA 510(k) clearance for Stryker Orthopaedics Hip Systems Labeli... by Stryker Orthopaedics. It is a Class 2 Orthopedic device (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)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

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
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K153345.
UTF Stem, reduced, #0, #00
K163193 · United Orthopedic Corporation · Jun 2017
Bencox M Stem Lateralized & Bencox Mirabo Cup System
K162127 · Corentec Co., Ltd. · Dec 2016
G7 Dual Mobility System, Active Articulation System
K161190 · Biomet, Inc. · May 2016
Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug
K152084 · Corentec Co., Ltd. · Apr 2016
REDAPT Porous Acetabular Shell and Cemented Liner
K150790 · Smith & Nephew, Inc. · Nov 2015
Arcos One-piece Femoral Revision System
K151603 · Biomet, Inc. · Oct 2015