Cleared Special

Klassic HD® Hip System (K171962) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K171962 · Total Joint Othopedics, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2017
Decision
24d
Days
Class 2
Risk

K171962 is an FDA 510(k) clearance for the Klassic HD® Hip System. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Total Joint Othopedics, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on July 24, 2017 after a review of 24 days - a notably fast clearance 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Total Joint Othopedics, Inc. devices

Submission Details

510(k) Number K171962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2017
Decision Date July 24, 2017
Days to Decision 24 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 122d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 325
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K171962.
Birmingham Hip (BH) Dual Mobility Insert
K171934 · Smith & Nephew, Inc. · Nov 2017
Smith & Nephew, Inc. REDAPT Augments
K171073 · Smith & Nephew, Inc. · Nov 2017
Smith & Nephew, Inc. ANTHOLOGY™ AFIT Hip Stem
K172684 · Smith & Nephew, Inc. · Oct 2017
G7 Dual Mobility System, Active Articulation System
K161190 · Biomet, Inc. · May 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