Cleared Traditional

K150496 - Total Knee Arthroplasty System

K150496 is an FDA 510(k) clearance for Total Knee Arthroplasty System, manufactured by Responsive Orthopedics, LLC. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K150496 · Responsive Orthopedics, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
107d
Days
Class 2
Risk

K150496 is an FDA 510(k) clearance for the Total Knee Arthroplasty System. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Responsive Orthopedics, LLC (Wayzata, US). The FDA issued a Cleared decision on June 12, 2015 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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.

FDA 510(k) Submission Details - K150496

510(k) Number K150496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2015
Decision Date June 12, 2015
Days to Decision 107 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
15d faster than avg
Panel avg: 122d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWH Device Classification - Class 2, Special Controls

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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 Consultant

Cor Medical Ventures, LLC
Jude Paganelli

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 913
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K150496.
Exactech Optetrak Logic Enhanced Assembly
K152170 · Exactech, Inc. · Sep 2015
Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides
K150928 · Materialise NV · Aug 2015
Progressive Orthopaedic Total Knee System
K150783 · The Progressive Orthopaedic Company, LLC · Jun 2015
Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System
K150544 · Aesculap Implant Systems, LLC · May 2015
Exactech Optetrak Logic CC
K150890 · Exactech, Inc. · May 2015
Rebel 3DKNEE System
K143242 · Encore Medical, L.P. · May 2015