Cleared Traditional

K183344 - The Progressive Orthopaedic Company Tot...

K183344 is the FDA 510(k) clearance for The Progressive Orthopaedic Company Tot... by The Progressive Orthopaedic Company, LLC. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K183344 · The Progressive Orthopaedic Company, LLC · Orthopedic device
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Mar 2019
Decision
105d
Days
Class 2
Risk

K183344 is an FDA 510(k) clearance for the The Progressive Orthopaedic Company Total Knee System II. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by The Progressive Orthopaedic Company, LLC (Palm Beach Gardens, US). The FDA issued a Cleared decision on March 18, 2019 after a review of 105 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 The Progressive Orthopaedic Company, LLC devices

Submission Details

510(k) Number K183344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2018
Decision Date March 18, 2019
Days to Decision 105 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
17d faster than avg
Panel avg: 122d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

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