Cleared Traditional

K160159 - Active-X Total Knee System

K160159 is the FDA 510(k) clearance for Active-X 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 223-day FDA review.

K160159 · Signature Orthopaedics Pty, Ltd. · Orthopedic device
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Sep 2016
Decision
223d
Days
Class 2
Risk

K160159 is an FDA 510(k) clearance for the Active-X 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 September 6, 2016 after a review of 223 days - an extended review cycle.

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 K160159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2016
Decision Date September 06, 2016
Days to Decision 223 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
101d slower than avg
Panel avg: 122d · This submission: 223d
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 K160159.
LOSPA Modular Knee System
K160157 · Corentec Co., Ltd. · Dec 2016
Materialise TKA Guide System
K162273 · Materialise NV · Nov 2016
EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)
K161945 · Encore Medical, L.P. · Sep 2016
ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)
K161668 · Conformis, Inc. · Jul 2016
ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)
K161366 · Conformis, Inc. · Jun 2016
EMPOWR PS Knee System
K160342 · Encore Medical, L.P. · May 2016