Cleared Special

Klassic Knee System Tibial Inserts, PS-Max (K202740) - FDA 510(k) Clearance

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

K202740 · Total Joint Orthopedics, Inc. · Orthopedic device
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Oct 2020
Decision
21d
Days
Class 2
Risk

K202740 is an FDA 510(k) clearance for the Klassic Knee System Tibial Inserts, PS-Max. 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 October 9, 2020 after a review of 21 days - a notably fast clearance cycle.

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

Submission Details

510(k) Number K202740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2020
Decision Date October 09, 2020
Days to Decision 21 days
Submission Type Special
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
101d faster than avg
Panel avg: 122d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 521
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K202740.
GMK Total Knee System - TiNbN Coating
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Mobio Total Knee System
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GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS (Vitamin E Highly Crosslinked UHMWPE)
K202022 · Medacta International S.A. · Sep 2020
EXULT Femoral component trial - Left, EXULT Femoral component trial - Right
K201851 · Corentec Co., Ltd. · Jul 2020
Triathlon Total KneeSystem
K201343 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Jul 2020