Cleared Traditional

K180743 - Balanced Knee Revision System - Offset ...

K180743 is an FDA 510(k) clearance for Balanced Knee Revision System - Offset ..., manufactured by Ortho Development Corporation. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K180743 · Ortho Development Corporation · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2018
Decision
90d
Days
Class 2
Risk

K180743 is an FDA 510(k) clearance for the Balanced Knee Revision System - Offset Junction Box. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Ortho Development Corporation (Draper, US). The FDA issued a Cleared decision on June 20, 2018 after a review of 90 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 Ortho Development Corporation devices

FDA 510(k) Submission Details - K180743

510(k) Number K180743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2018
Decision Date June 20, 2018
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 K180743.
ASK System
K181146 · L and K Biomed Corporation Limited · Aug 2018
EMPOWR VVC TIBIAL INSERT
K180930 · Encore Medical, L.P. · Jul 2018
A3 Total Knee System
K180493 · Beijing AK Medical Co., Ltd. · Jun 2018
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System
K180906 · Conformis, Inc. · May 2018
World Knee System
K180750 · Signature Orthopaedics Pty, Ltd. · Apr 2018
Zimmer Knee Joint Replacement Prostheses MR Labeling
K173057 · Zimmer, Inc. · Mar 2018