(233 days)
No
The summary describes a mechanical knee replacement system and does not mention any AI or ML components.
Yes
The device is a total knee replacement system, which clearly falls under the definition of a therapeutic device designed to relieve pain and disability.
No
The device is a total knee replacement system, intended for surgical implantation to relieve pain and disability from arthritis, not for diagnosing conditions.
No
The device description clearly outlines physical components (femoral component, tibial tray, polyethylene bearing, patella) that are implanted in the body, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "total knee replacement" for the relief of pain and disability. This is a surgical implant, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility.
- Device Description: The description details the components of a knee implant (femoral component, tibial tray, polyethylene bearing, patella). This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information.
Therefore, this device falls under the category of a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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 cemented system with fixed tibial bearing is intended for cemented use only.
Product codes
JWH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K000232, K872379, K984158, K991581
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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 NOETOS
System | ROTAGLIDE +
Total Knee
System | BURSTEIN II
posterior-
stabilized | PFC Modular
Total Knee
System | NEX-GEN
Complete Knee
Solution LPS | SE? | |
|---------------------------------------|----------------------|-----------------------------------------|-----------------------------------------|-------------------------------------|------------------------------------------|----------------|-----|
| Materials | Femoral
part | CoCr | CoCr + plasma
spray | CoCr | CoCr | CoCr | YES |
| | Tibial
bearing | UHMWPE | UHMWPE | UHMWPE | UHMWPE | UHMWPE | YES |
| | Tibial
tray | CoCr | CoCr + plasma
spray | Titanium alloy | Titanium alloy | Titanium alloy | YES |
| | Patella | UHMWPE | UHMWPE | UHMWPE | UHMWPE | UHMWPE | YES |
| Posterior
stabilized | | yes | yes | yes | yes | yes | YES |
| Method of
Fixation | | Cemented | same | same | same | same | YES |
| Indications for
Use | | Total knee
replacement | same | same | same | same | YES |
| Standards
Specifications
CoCr | | ISO 5832-4
ISO 5832-7
ISO 5832-12 | same | ASTM F 75 | ASTM F 75 | ASTM F 75 | YES |
| Standards
Specifications
UHMWPE | | ISO5834-2 | same | same | same | same | YES |
| Sterilization
method | | 2.5 Mrad
Gamma radiation | same | same | Gamma vacuum
foil | 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):
HLS NOETOS System with fixed tibial bearing 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 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)