Cleared Traditional

K013906 - HLS NOETOS SYSTEM

K013906 is an FDA 510(k) clearance for HLS NOETOS SYSTEM, manufactured by Tornier. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K013906 · Tornier · Orthopedic device
Download Printable Device Report (PDF)
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Jul 2002
Decision
233d
Days
Class 2
Risk

K013906 is an FDA 510(k) clearance for the HLS NOETOS SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Tornier (Montbonnot, FR). The FDA issued a Cleared decision on July 17, 2002 after a review of 233 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 Tornier devices

FDA 510(k) Submission Details - K013906

510(k) Number K013906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2001
Decision Date July 17, 2002
Days to Decision 233 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
111d slower than avg
Panel avg: 122d · This submission: 233d
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 884
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K013906.
UKNEE TOTAL KNEE SYSTEM
K021657 · United Orthopedic Corp. · Aug 2002
NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE
K021578 · Sulzer Orthopedics, Inc. · Aug 2002
SEARCH EVOLUTION TOTAL KNEE SYSTEM
K021313 · Aesculap, Inc. · Jul 2002
3D KNEE
K020114 · Encore Orthopedics, Inc. · Jul 2002
PROVEN MODULAR POSTERIOR STABILIZED FEMORAL
K021908 · Stelkast Company · Jul 2002
SCORPIO INSET PATELLAR COMPONENT
K020830 · Howmedica Osteonics Corp. · Jun 2002