This device is indicated for use as a total knee replacement for the relief of pain and significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis. This device is also indicated for the revision of knee prosthesis. The HLS NOETOS cemented system with fixed tibial bearing is intended for cemented use only.

Device Description

The HLS NOETOS System is intended for use as a total knee replacement system sacrificing the cruciate ligaments. The HLS NOETOS System provides the flexibility needed to adapt the therapentic solution to the patients need. All the type of implants have been designed with the same objectives: to restore the joint line both in flexion and in extension without altering the patellar height. to restore the articular morphology and to preserve bone stock. The design of the implant, particularly the tibial one, guarantees the antero-posterior stability, by a third femoral condyle that engages a tibial cam during flexion. The HLS NOETOS System consists of the association of three components: a femoral component, a tibial tray associated with a polyethylene bearing and a polyethylene patella can be preserved if it is in good state or resurfaced by the patellar implant.

AI/ML Overview

The provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria.

This document is a 510(k) premarket notification for a medical device (HLS NOETOS System). The primary purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its clinical effectiveness through detailed performance studies with acceptance criteria in the way you've outlined.

The key aspects of this document are:

Device Description: What the HLS NOETOS System is, its components, and materials.
Intended Use/Indications: The conditions for which the device is designed (e.g., total knee replacement for osteoarthritis).
Comparison to Predicate Devices: This is the core of the 510(k). The document lists several predicate devices (ROTAGLIDE+, INSALL/BURSTEIN II, PFC Modular Total Knee System, NEX-GEN Complete Knee Solution LPS) and performs a side-by-side comparison of features like materials, fixation methods, indications for use, and compliance with standards. The "SE?" column likely stands for "Substantially Equivalent?".
FDA Clearance: The letter from the FDA confirms that based on the submitted information, the HLS NOETOS System is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

While the document mentions compliance with ISO standards for materials (e.g., ISO 5832-4 for CoCr, ISO 5834-2 for UHMWPE), these are material specifications, not acceptance criteria for overall device performance in a clinical study.

Therefore, I cannot fill out your table or answer your specific questions about acceptance criteria, study details, sample sizes, expert ground truth, adjudication, or MRMC studies because this information is not present in the provided text. A 510(k) submission typically relies on a comparison to predicate devices, and often the clinical performance data (if any is required beyond equivalence) would be summarized in a much higher-level fashion or referenced rather than detailed in this specific type of public summary.

Summary

{0}------------------------------------------------

Summary of Safety and Effectiveness information	HLS NOETOS System
Premarket Notification, Section 510(k)	Tornier S.A.

Safe Medical Devices Act of 1990, 21 CRF 807.92 Regulatory authority:

Device name

HLS NOETOS System Trade name: Total anatomical knee prosthesis Common name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained Classification name:

2) Submitter

Tornier S.A. Mrs Anne Le Rouzo Regulatory affairs and Quality Manager B.P. 11 - Rue Doyen Gosse 38330 Saint Ismier France Tel: 00 33 4 76 61 35 19 Fax: 00 33 4 76 61 35 44 e-mail : anne.le.rouzo@tornier.fr

3) Company contact

Tornier S.A. Mrs Mireille Lémery Regulatory affairs & Quality Engineer ZIRST - 161, rue Lavoisier 38330 Montbonnot France Tel: 00 33 4 76 61 38 98 Fax: 00 33 4 76 61 35 44 e-mail : mireille.lemery@tornier.fr

4) Classification

Sec. 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. (a) Identification. A knee joint patellofemorotibial polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geomery of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (Sec. 888.3027). (b) Classification. Class II.

Device class:	Class II
Classification panel:	Orthopedic
Product code:	87JWH

5) Equivalent / Predicate device

ROTAGLIDE + Total Knee System, Corin Medical (K000232), INSALL/BURSTEIN II, Zimmer (K872379), PFC Modular Total Knee System, DePuy (K984158), NEX-GEN Complete Knee Solution Legacy Posterior Stabilized, Zimmer (K991581).

{1}------------------------------------------------

6) Device description

K013906
page 2 of 3

The usual goal of total knee replacement is to restore the knee joint to its best working condition and to reduce or eliminate pain. The HLS NOETOS System is intended to accomplish these goals. The HLS NOETOS System is intended for use as a total knee replacement system sacrificing the cruciate ligaments. The HLS NOETOS System provides the flexibility needed to adapt the therapentic solution to the patients need. All the type of implants have been designed with the same objectives:

to restore the joint line both in flexion and in extension without altering the patellar height. -
। to restore the articular morphology and to preserve bone stock.

The design of the implant, particularly the tibial one, guarantees the antero-posterior stability, by a third femoral condyle that engages a tibial cam during flexion.

The HLS NOETOS System consists of the association of three components: a femoral component, a tibial tray associated with a polyethylene bearing and a polyethylene patella can be preserved if it is in good state or resurfaced by the patellar implant.

7) Materials

The femoral part is manufactured from Cobalt-Chromium alloy according to ISO standard 5832-4. The articulating surface, in contact with the bearing component, is mirror polished and the finished aspect of the part in contact with the bone is fine shot-blasted. The tibial tray is also made from Cobalt-Chromium allov according to ISO standard 5832-4. The finished aspect is fine shot-blasted. The extension tibial stem and the tibial plug are also made from Cobalt-Chromium alloy according to ISO Standard 5832-7 or ISO Standard 5832-12. The fixed bearing component and the patella are manufactured from implant grade ultra-high molecular weight polyethylene (UHMWPE) according to ISO standard 5834-2.

8) Indications

This device is indicated for use as a total knee replacement for the relief of pain and significant disability following the effects of primary or secondary osteoarthritis and theumatoid arthritis. This device is also indicated for the revision of knee prosthesis.

The HLS NOETOS cemented system with fixed tibial bearing is intended for cemented use only.

{2}------------------------------------------------

9) Comparison table

Comparison table

	HLS NOETOS System	ROTAGLIDE + Total Knee System	INSALL/ BURSTEIN II posterior- stabilized	PFC Modular Total Knee System	NEX-GEN Complete Knee Solution LPS	SE?
Femoral		CoCr + plasma

	HLS NOETOSSystem	ROTAGLIDE +Total KneeSystem	BURSTEIN IIposterior-stabilized	PFC ModularTotal KneeSystem	NEX-GENComplete KneeSolution LPS	SE?
Materials	Femoralpart	CoCr	CoCr + plasmaspray	CoCr	CoCr	CoCr	YES
	Tibialbearing	UHMWPE	UHMWPE	UHMWPE	UHMWPE	UHMWPE	YES
	Tibialtray	CoCr	CoCr + plasmaspray	Titanium alloy	Titanium alloy	Titanium alloy	YES
	Patella	UHMWPE	UHMWPE	UHMWPE	UHMWPE	UHMWPE	YES
Posteriorstabilized		yes	yes	yes	yes	yes	YES
Method ofFixation		Cemented	same	same	same	same	YES
Indications forUse		Total kneereplacement	same	same	same	same	YES
StandardsSpecificationsCoCr		ISO 5832-4ISO 5832-7ISO 5832-12	same	ASTM F 75	ASTM F 75	ASTM F 75	YES
StandardsSpecificationsUHMWPE		ISO5834-2	same	same	same	same	YES
Sterilizationmethod		2.5 MradGamma radiation	same	same	Gamma vacuumfoil	same	YES
	Manufacturer	TORNIER. SA	Corin Medical	Zimmer	DePuy	Zimmer	-
K-number		K013906	K000232	K872379	K984158	K991581	-

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked one above the other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 7 2002

Ms. Mireille Lémery Regulatory Affairs & Ouality Engineer Tornier S.A. ZIRST -- 161, rue Lavoisier 38330 Montbonnot France

Re: K013906

Trade/Device Name: HLS NOETOS System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: April 16, 2002 Received: April 18, 2002

Dear Ms. Lémery:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{4}------------------------------------------------

Page 2 - Ms. Mireille Lémery

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your deyice to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Mark McMillan

Celia M. Witten. Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Page 1 of

510(k) Number (if known):

K013906

HLS NOETOS System with fixed tibial bearing Device name:

Indication for use:

The HLS NOETOS cemented system with fixed tibial bearing is intended for cemented use only.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative and Neurological Devices

510(k) Number	K013906
Prescription use	X	OR	Over-The-Counter Use

(Per 21 CFR 801.109) (Optional format 1-2-96)

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.