Cleared Special

Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly (K190280) - FDA 510(k) Clearance

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

K190280 · Total Joint Orthopedics, Inc. · Orthopedic device
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Mar 2019
Decision
35d
Days
Class 2
Risk

K190280 is an FDA 510(k) clearance for the Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee Syste.... 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 15, 2019 after a review of 35 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 K190280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2019
Decision Date March 15, 2019
Days to Decision 35 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
87d faster than avg
Panel avg: 122d · This submission: 35d
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 K190280.
LINK GEMINI SL Total Knee System
K182872 · Waldemar Link GmbH & Co. KG · Apr 2019
Klassic Knee System - Klassic Knee PS-Post Femur
K183596 · Total Joint Orthopedics, Inc. · Mar 2019
The Progressive Orthopaedic Company Total Knee System II
K183344 · The Progressive Orthopaedic Company, LLC · Mar 2019
Stabil Orthopaedic Solutions Total Knee System
K183225 · Stabil Orthopaedic Solutions, LLC · Feb 2019
MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component
K183025 · B-One Ortho, Corp. · Jan 2019
Freedom Ultra-Congruent CR Tibial Liner
K182574 · Maxx Orthopedics, Inc. · Jan 2019