Cleared Traditional

K183596 - Klassic Knee System - Klassic Knee PS-P...

Also marketed or referenced as:
Klassic Knee Tibial Insert, PS-Post, Std Poly Klassic Knee Tibial Insert, PS-Post, E-Link Poly

K183596 is an FDA 510(k) clearance for Klassic Knee System - Klassic Knee PS-P..., manufactured by Total Joint Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K183596 · Total Joint Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2019
Decision
98d
Days
Class 2
Risk

K183596 is an FDA 510(k) clearance for the Klassic Knee System - Klassic Knee PS-Post Femur. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Total Joint Orthopedics, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on March 29, 2019 after a review of 98 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.

View all Total Joint Orthopedics, Inc. devices

FDA 510(k) Submission Details - K183596

510(k) Number K183596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2018
Decision Date March 29, 2019
Days to Decision 98 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
24d faster than avg
Panel avg: 122d · This submission: 98d
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 Peers - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 800
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K183596.
Vanguard Complete Knee System
K183583 · Zimmer, Inc. · May 2019
InterSpace Knee Extra-Large Size, InterSpace Knee ATS
K181732 · Tecres S.P.A. · Apr 2019
LINK GEMINI SL Total Knee System
K182872 · Waldemar Link GmbH & Co. KG · Apr 2019
The Progressive Orthopaedic Company Total Knee System II
K183344 · The Progressive Orthopaedic Company, LLC · Mar 2019
Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly
K190280 · Total Joint Orthopedics, Inc. · Mar 2019
Stabil Orthopaedic Solutions Total Knee System
K183225 · Stabil Orthopaedic Solutions, LLC · Feb 2019