(180 days)
Not Found
No
The summary describes a mechanical knee prosthesis and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for the replacement of a joint to reduce pain and restore function in patients with osteoarthritis, which treats a medical condition.
No
The device is a knee prosthesis, indicated for the replacement of a knee joint compartment to reduce pain and restore function. It is a treatment device, not a diagnostic one.
No
The device description clearly states it consists of metallic components (femoral and tibial) and polyethylene, indicating it is a physical implant, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to replace a part of the knee joint to reduce pain and restore function. This is a surgical implant, not a test performed on samples taken from the body.
- Device Description: The device is described as a knee prosthesis consisting of metallic and polyethylene components. This is a physical implant.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly a medical device intended for surgical implantation to treat a physical condition (osteoarthritis).
N/A
Intended Use / Indications for Use
The HLS Uni Evolution and U-KneeTec unicompartmental knee prostheses are indicated for the replacement of the medial or lateral compartment of the femorotibial knee joint when only one compartment is affected, in order to reduce pain and restore knee function in comparison with preoperative status.
These devices are indicated in the treatment of primary or secondary femorotibial osteoarthritis. The HLS Uni Evolution and U-KneeTec knee prostheses are intended for cemented use only.
Product codes
HSX
Device Description
The usual goal of a unicompartmental knee prosthesis is to restore the knee joint to its best working condition and to reduce or eliminate pain when only one side of the joint is affected. The HLS Uni Evolution prosthesis is intended to replace the medial or lateral compartment of the femorotibial knee joint. This system is an intermediate solution between osteotomy and total prosthesis.
The HLS Uni Evolution prosthesis consists of a metallic distal femoral resurfacing component and a tibial component. Two kinds of tibial component may be associated to the femoral component: one all polyethylene tibial component and one polyethylene metal-backed tibial component.
The present device modification submission consists in the addition of a new femoral component, named U-KneeTec, to the current cleared range.
This new component is the distal resection version of the HLS Uni Evolution. The U-KneeTec has been designed to be used in association with the already cleared polyethylene tibial component of HLS Uni Evolution.
The U-KneeTec is intended for cemented use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femorotibial 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)
Non-clinical testing was not necessary to determine substantial equivalence between the U-KneeTec and the cited predicate devices.
It has been determined that the proposed new U-KneeTec described in this submission does not induce any new or higher risk compared to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
TORI Implants Chirurgicaux
JUL 2 5 2012
Summary of Safety and Effectiveness information Special 510(k) Premarket Notification - HLS Uni Evolution
Date prepared: July 24th, 2012
Regulatory authority: Safe Medical Devices Act of 1990, 21 CFR 807.92
- Device name
| Trade name: |
|---|
| Common name: |
| Classification name: |
HLS Uni Evolution & U-KneeTec Unicompartmental Knee Prosthesis §888.3520, Knee joint femorotibial metal/polymer non-constrained cemented prosthesis
2) Submitter
Tornier Rue Doyen Gosse 38330 Saint Ismier - France
3) Applicant
Tornier, Inc. 7701 France avenue South Edina MN 55345 - USA
4) Company contact
Tornier Mrs Stephanie Bernard Regulatory Affairs Specialist 161, rue Lavoisier - Montbonnot 38334 Saint Ismier Cedex - France Tel: + 33 (0)4 76 61 35 00 Fax: + 33 (0)4 76 61 35 59 e-mail: stephanie.bernard(@tornier.fr
5) Classification
| Device class: | Class II |
|---|---|
| Classification panel: | Orthopedic |
| Product code: | HSX |
Image /page/0/Picture/17 description: The image shows a logo with a stylized letter "T" inside a hexagon. The "T" is constructed from thick lines, giving it a bold and geometric appearance. The logo is black and white, with the "T" and the hexagon outline being black against a white background. The overall design is simple and modern.
TORNIER S.A.S. 161, rue Lavoisier - Montbonnot 38334 SAINT-ISMIER CEDEX FRANCE
Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33
SIEGE SOCIAI. : rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE
Section 5 - Page 1/ page 3
S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 13 R.C.S. : 070 501 275 CODE APE : 331 B
1
6) Equivalent / Predicate device
HLS Uni Evolution, Tornier, K022211
M/G Miller-Galante Unicompartmental Knee System, Zimmer, Inc., K880155 and K942263
4120262
7) Device description
The usual goal of a unicompartmental knee prosthesis is to restore the knee joint to its best working condition and to reduce or eliminate pain when only one side of the joint is affected. The HLS Uni Evolution prosthesis is intended to replace the medial or lateral compartment of the femorotibial knee joint. This system is an intermediate solution between osteotomy and total prosthesis.
The HLS Uni Evolution prosthesis consists of a metallic distal femoral resurfacing component and a tibial component. Two kinds of tibial component may be associated to the femoral component: one all polyethylene tibial component and one polyethylene metal-backed tibial component.
The present device modification submission consists in the addition of a new femoral component, named U-KneeTec, to the current cleared range.
This new component is the distal resection version of the HLS Uni Evolution. The U-KneeTec has been designed to be used in association with the already cleared polyethylene tibial component of HLS Uni Evolution.
The U-KneeTec is intended for cemented use only.
8) Materials
The U-KneeTec is manufactured from chromium cobalt alloy according to ISO 5832-4.
9) Indications for use
The HLS Uni Evolution and U-KneeTec unicompartmental knee prostheses are indicated for the replacement of the medial or lateral compartment of the femorotibial knee joint when only one compartment is affected, in order to reduce pain and restore knee function in comparison with preoperative status.
These devices are indicated in the treatment of primary or secondary femorotibial osteoarthritis. The HLS Uni Evolution and U-KneeTec knee prostheses are intended for cemented use only.
Image /page/1/Picture/14 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is formed by two curved lines at the top and a vertical line in the center, with a hexagonal shape in the middle. The logo is black and white and appears to be a simple, geometric design.
TORNIER S.A.S. 161, rue Lavoisier - Montbonnot 38334 SAINT-ISMIER CEDEX FRANCE
Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33
Section 5 - Page 2/ page 3
S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 13 R.C.S. : 070 501 275 CODE APE : 331 B
SIEGE SOCIAL : rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE
2
10) Summary of technological characteristics
| Main features or system
| characteristics | U-KneeTec | HLS Uni Evolution | M/G Miller Galante |
|---|---|---|---|
| Materials | CoCr | CoCr | Zimaloy® CoCrMo |
| Kind of prosthesis | Resecting | Resurfacing | Resecting |
| Method of fixation | cemented | cemented | cemented |
| Sizes | 5 sizes | 5 sizes | 7 sizes with, for each, 2 |
| implants: left medial/right | |||
| lateral or right medial/left | |||
| lateral | |||
| Anchorage | 1 peg & 1 fin | 1 peg & 1 fin | 2 pegs |
| Indications for use | Unicompartmental knee | ||
| replacement | Unicompartmental knee | ||
| replacement | Unicompartmental knee | ||
| replacement | |||
| Terminal sterilization | Gamma | Gamma | Gamma |
| Manufacturer | Tornier | Tornier | Zimmer |
| K-number | pending | K022211 | K880155 and K942263 |
The indications for use, the technical characteristics (manufacturing principle and method of fixation), the packaging and the sterilization process of the new U-KneeTec implant are similar or identical to the predicate devices.
11) Non-clinical testing
Non-clinical testing was not necessary to determine substantial equivalence between the U-KneeTec and the cited predicate devices.
It has been determined that the proposed new U-KneeTec described in this submission does not induce any new or higher risk compared to the predicate devices.
12) Substantial equivalence conclusion
The U-KneeTec has the same intended use and similar indications, technological characteristics (general features, material, means of fixation, dimensions) as its predicate devices. The new femoral component U-KneeTec is substantially equivalent to the predicate devices.
Image /page/2/Picture/10 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is designed with thick, bold lines and has a slightly geometric appearance. The hexagon provides a clear, defined border around the central letter, making the logo distinct and recognizable.
TORNIER S.A.S. 161, rue Lavoisier - Montbonnot 38334 SAINT-ISMIER CEDEX FRANCE
Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33
SIEGE SOCIAL : rue du Doyen Gosse - 38330 SAINT-JSMIER - FRANCE
Section 5 - Page 3/ page 3
S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 13 R.C.S. : 070 501 275 CODE APE : 331 B
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized symbol resembling a bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 25 2012
Tornier, Incorporated % Ms. Stéphanie Bernard Regulatory Affairs Specialist 161 rue Lavoisier, Montbonnot 38334 Saint-Ismier Cedex France
Re: K120262
Trade/Device Name: HLS Uni Evolution & U-KneeTec Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: HSX Dated: July 12, 2012 Received: July 13, 2012
Dear Ms. Bernard:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
4
Page 2 - Ms. Stéphanie Bernard
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Eunel Keith
fo Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Premarket Notification: Special 510(k) HLS Uni Evolution
Indications for Use
posell
KI20262 510(k) Number (if known):
Device Name: HLS Uni Evolution & U-KneeTec
Indications For Use:
The HLS Uni Evolution and U-KneeTec unicompartmental knee prostheses are indicated for the replacement of the medial or lateral compartment of the femorotibial knee joint when only one compartment is affected, in order to reduce pain and restore knee function in comparison with preoperative status.
These devices are indicated in the treatment of primary or secondary femorotibial osteoarthritis. The HLS Uni Evolution and U-KneeTec knee prostheses are intended for cemented use only.
Abr
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
KIZOZ62 510(k) Number
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)