Cleared Traditional

K151440 - Klassic HD Hip System

K151440 is an FDA 510(k) clearance for Klassic HD Hip System, manufactured by Total Joint Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K151440 · Total Joint Orthopedics, Inc. · Orthopedic device
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Sep 2015
Decision
97d
Days
Class 2
Risk

K151440 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 Orthopedics, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on September 3, 2015 after a review of 97 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 Total Joint Orthopedics, Inc. devices

FDA 510(k) Submission Details - K151440

510(k) Number K151440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2015
Decision Date September 03, 2015
Days to Decision 97 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
25d faster than avg
Panel avg: 122d · This submission: 97d
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 454
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K151440.
REDAPT Porous Acetabular Shell and Cemented Liner
K150790 · Smith & Nephew, Inc. · Nov 2015
Arcos One-piece Femoral Revision System
K151603 · Biomet, Inc. · Oct 2015
Exactech® Novation® Crown Cup®
K141960 · Exactech, Inc. · Sep 2015
U2 Hip Stem, Ti Porous Coated, Matrix
K151316 · United Orthopedic Corporation · Aug 2015
Continuum and Trilogy Integrated Taper (IT) Acetabular Systems
K151448 · Zimmer, Inc. · Aug 2015
Restoration Anatomic Shell
K151264 · Stryker Orthopaedics · Aug 2015