Cleared Traditional

K143085 - Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach

K143085 is an FDA 510(k) clearance for Stryker Orthopaedics Acetabular Shells, 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 105-day FDA review.

K143085 · Stryker Orthopaedics · Orthopedic device
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Feb 2015
Decision
105d
Days
Class 2
Risk

K143085 is an FDA 510(k) clearance for the Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instrumen.... 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 February 9, 2015 after a review of 105 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 Stryker Orthopaedics devices

FDA 510(k) Submission Details - K143085

510(k) Number K143085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2014
Decision Date February 09, 2015
Days to Decision 105 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
17d faster than avg
Panel avg: 122d · This submission: 105d
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 554
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K143085.
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OMNI Interface Acetabular System
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K142606 · Mako Surgical Corp. · Jan 2015
EXCERA FITRITE TOTAL HIP ARTHROPLASTY SYSTEM
K140547 · Excera Orthopedics, Inc. · Jan 2015