Cleared Traditional

K170613 - Genius Total Knee System

K170613 is the FDA 510(k) clearance for Genius Total Knee System by Signature Orthopaedics Pty, Ltd.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K170613 · Signature Orthopaedics Pty, Ltd. · Orthopedic device
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Jul 2017
Decision
138d
Days
Class 2
Risk

K170613 is an FDA 510(k) clearance for the Genius Total 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 July 17, 2017 after a review of 138 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 Signature Orthopaedics Pty, Ltd. devices

Submission Details

510(k) Number K170613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2017
Decision Date July 17, 2017
Days to Decision 138 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
16d slower than avg
Panel avg: 122d · This submission: 138d
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

All 769
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K170613.
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K171389 · Microport Orthopedics, Inc. · Aug 2017
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Empowr CR Knee Tibial Insert
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K170282 · Smith & Nephew, Inc. · May 2017
ANTHEM CR Total Knee System
K170648 · Smith & Nephew, Inc. · May 2017