Cleared Special

K180750 - World Knee System

K180750 is the FDA 510(k) clearance for World Knee System by Signature Orthopaedics Pty, Ltd.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Special 510(k) pathway after a 29-day FDA review.

K180750 · Signature Orthopaedics Pty, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
29d
Days
Class 2
Risk

K180750 is an FDA 510(k) clearance for the World Knee System. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Signature Orthopaedics Pty, Ltd. (Lane Cove West, AU). The FDA issued a Cleared decision on April 20, 2018 after a review of 29 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 Signature Orthopaedics Pty, Ltd. devices

Submission Details

510(k) Number K180750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2018
Decision Date April 20, 2018
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
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 769
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K180750.
A3 Total Knee System
K180493 · Beijing AK Medical Co., Ltd. · Jun 2018
Balanced Knee Revision System - Offset Junction Box
K180743 · Ortho Development Corporation · Jun 2018
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System
K180906 · Conformis, Inc. · May 2018
Zimmer Knee Joint Replacement Prostheses MR Labeling
K173057 · Zimmer, Inc. · Mar 2018
Acculoc Total Knee System
K170753 · Rootloc Co., Ltd. · Mar 2018
Klassic® Knee System
K180159 · Total Joint Orthopedics, Inc. · Mar 2018