(87 days)
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 Revision prosthesis is intended for cemented use only.
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 implant and the therapeutic 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 specific tibial bearing area during flexion. The HLS NOETOS System - Revision prosthesis consists of the association of three components: a femoral component, a tibial tray associated with a polyethylene bearing and a patellar implant. The patella can be preserved if it is in good state or resurfaced by the patellar implant. Femoral and tibial augments as well as femoral and tibial extension stems can be added in order to compensate for bone loss.
This is a 510(k) premarket notification for a medical device (HLS NOETOS System - Revision prosthesis), not an AI/ML device. Therefore, the requested information regarding acceptance criteria and a study proving a device meets these criteria in the context of AI/ML performance (such as sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance) is not applicable or available in the provided document.
The document describes a traditional medical device (knee joint prosthesis) and its substantial equivalence to predicate devices, which is a regulatory pathway that does not involve the type of performance evaluation typically conducted for AI/ML software.
The provided text focuses on:
- Device Name: HLS NOETOS System - Revision prosthesis
- Submitter: Tornier S.A.
- Classification: Class II medical device (Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis)
- Predicate Devices: PFC Modular Total Knee System (DePuy), NEX-GEN Complete Knee Solution Legacy Constrained Condylar Knee L-CCK (Zimmer), HLS Noetos System (Tornier).
- Device Description: A total knee replacement system consisting of a femoral component, a tibial tray with a polyethylene bearing, and an optional patellar implant, designed to restore joint line, articular morphology, and preserve bone stock.
- Materials: Cobalt-Chromium alloy for femoral part, tibial tray, spacers, stem adaptors, and sleeve.
- Indications for Use: Total knee replacement for relief of pain and disability due to primary/secondary osteoarthritis and rheumatoid arthritis, and revision of knee prosthesis. Intended for cemented use only.
- FDA Decision: Substantial equivalence determination to legally marketed predicate devices, allowing the device to be marketed.
Therefore, I cannot provide the requested information in the format specified, as it pertains to AI/ML device evaluation, which is not relevant to this document.
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OCT = 2 2003
Image /page/0/Picture/1 description: The image shows the word "TORNIER" in large, bold, sans-serif font. Below it, in a smaller font, are the words "Implants Chirurgicaux". The text appears to be a logo or heading, possibly for a medical or surgical company specializing in implants.
510(k) Summary of Safety and Effectiveness information HLS NOETOS System - Revision prosthesis
Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92
1) Device name
| Trade name: | HLS NOETOS System |
|---|---|
| Common name: | Total anatomical knee prosthesis |
| Classification name: | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained |
2) Submitter
Tornier S.A. B.P. 11 - Rue Doyen Gosse 38330 Saint Ismier - France
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 33 e-mail : mireille lemery@tornier.fr
4) Classification
Device class: Class II Classification panel: Orthopedic 87JWH Product code: Sec. 888.3560 Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis
Image /page/0/Picture/12 description: The image shows a logo inside of a hexagon. The logo appears to be a stylized letter "T". The letter is black and the background is white.
TORNIER S.A 161, rue Lavoisier 38330 MONTBONNOT FRANCE
Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33
S.A. au capital de 1 800 000 F SIRET : 070 501 275 000 13 R.C.S. : B 070 501 275 CODE APE : 331 B
Page 1/ page 2
SIEGE SOCIAL : B.P. 11 - rue du Doyen Gosse - 38330 SAINT-ISMIFR - FRANCE
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632079
$\rho^2/2$
5) Equivalent / Predicate device
- PFC Modular Total Knee System, DePuy (K984158), -
- NEX-GEN Complete Knee Solution Legacy Constrained Condylar Knee L-CCK, Zimmer (K963148) -
- HLS Noetos System, Tornier (K013906). -
6) Device description
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 implant and the therapeutic 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. ﺖ
The design of the implant, particularly the tibial one, guarantees the antero-posterior stability, by a third femoral condyle that engages a specific tibial bearing area during flexion.
The HLS NOETOS System - Revision prosthesis consists of the association of three components: a femoral component, a tibial tray associated with a polyethylene bearing and a patellar implant. The patella can be preserved if it is in good state or resurfaced by the patellar implant. Femoral and tibial augments as well as femoral and tibial extension stems can be added in order to compensate for bone loss.
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 shotblasted. The tibial tray is also made from Cobalt-Chromium alloy according to ISO standard 5832-4. The finished aspect is fine shotblasted. The femoral and tibial spacers, the femoral stem adaptor and the sleeve for femoral stem adaptor are also made from Cobalt-Chromium alloy according to ISO standard 5832-7 or ISO standard 5832-12.
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 rheumatoid arthritis. This device is also indicated for the revision of knee prosthesis.
The HLS NOETOS Revision prosthesis is intended for cemented use only.
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Image /page/1/Picture/24 description: The image shows a logo with a stylized letter "T" inside of a hexagon. The "T" is bold and has a unique design, with the top part resembling a roof or a bridge. The hexagon provides a clear border around the central design, making it stand out.
TORNIER S.A 161, rue Lavoisier 38330 MONTBONNOT FRANCE
Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33
S.A. au capital de 1 800 000 F SIRET : 070 501 275 000 13 R.C.S. : B 070 501 275 CODE APE : 331 B
SIEGE SOCIAL : B.P. 11 - rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with three stripes extending from its back.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 2 2003
Mrs. Mireille Lémery Regulatory Affairs and Quality Engineer Tornier, S.A. ZIRST - 161, rue Lavoisier 38330 Montbonnot France
Re: K032079
Trade/Device Name: HLS NOETOS System - Revision prosthesis 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: June 19, 2003 Received: July 7, 2003
Dear Mrs. 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.
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Page 2 - Mrs. 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 device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 yours,
Sincerely yours,
Mark N Mulkerson
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
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510(k) Number (if known): K032079
HLS NOETOS System - Revision prosthesis Device name:
Indication for use:
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 Revision prosthesis 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 | K032079 |
|---|---|
| --------------- | --------- |
| Prescription use | OR | Over-The-Counter Use |
|---|---|---|
| er 21 CFR 801.109) | (Optional format 1-2-96) |
(Per 21
§ 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.