(318 days)
Not Found
No
The description focuses on the materials and mechanical components of a knee prosthesis and does not mention any software, algorithms, or data processing capabilities indicative of AI/ML.
Yes.
The device is a prosthesis intended for the replacement of a joint, which falls under the definition of a therapeutic device designed to treat a medical condition.
No
The device is a prosthesis intended for surgical replacement of a knee joint compartment, not for diagnosing a medical condition.
No
The device description clearly outlines physical components made of metal and polyethylene intended for surgical implantation, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside of the body.
- Device Description: The provided text clearly describes a surgical implant intended to replace a part of the knee joint. This device is used inside the body during a surgical procedure.
The description focuses on the physical components, materials, and intended surgical use of the prosthesis, not on analyzing biological samples.
N/A
Intended Use / Indications for Use
The HLS Uni Evolution prosthesis is intended for the replacement of the medial or lateral compartment of the femoro-tibial knee joint, when only one side of the knee is affected. This device is indicated in case of primary or secondary femoro-tibial arthritis.
The HLS Uni Evolution prosthesis is intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
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 femoro-tibial knee joint. This system is an intermediate solution between osteotomy and total prosthesis.
The HLS Uni Evolution prosthesis of a metallic distal femoral resurfacing component and a tibial component. Two kinds of tibial component may be associated with the femoral component, one that is all polyethylene and one that is polyethylene metal-backed.
The femoral part is manufactured from cast 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 all polyethylene tibial component is manufactured from implant grade ultra-high molecular weight polyethylene (UHMWPE) according to ISO standard 5834-2. The metal backed tibial component is composed of a polyethylene part, made from implant grade ultra-high molecular weight polyethylene (UHMWPE) according to ISO standard 5834-2, inserted in a stainless steel metal back that conforms to ISO standard 5832-1.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoro-tibial 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Kozzll
page 143
Premarket Notification 510(1 HLS Uni Evolution prosthesis
Summary of Safety and Effectiveness information | HLS Uni Evolution prosthesis |
---|---|
Premarket Notification, Section 510(k) | Tornier S.A. |
Safe Medical Devices Act of 1990, 21 CRF 807.92 Regulatory authority:
MAY 22 2003
-
- Device name
Trade name: | HLS Uni Evolution prosthesis |
---|---|
Common name: | Unicompartmental Knee Prosthesis |
Classification name: | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, |
Metal/Polymer |
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 : mircille.lemery@tornier.fr
4) Classification
Sec. 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 minimally limits (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 components made of alloys, such as cobalt-chromium-molybdenum, and a tibial components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (Sec. 888.3027). (b) Classification. Class II.
Device class: | Class II |
---|---|
Classification panel: | Orthopedic |
Product code: | HSX |
ર) Equivalent / Predicate device
Miller / Gallante Precoat Unicompartmental, Zimmer, Inc; K010685 Advance Unicondylar Knee System, Wright Medical Technology, Inc; K014171 Link Endo-Model Sled Uni-Knee, Link America, Inc; K954186
1
HLS Uni Evolution prosthesis
6) 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 femoro-tibial knee joint. This system is an intermediate solution between osteotomy and total prosthesis.
The HLS Uni Evolution prosthesis of a metallic distal femoral resurfacing component and a tibial component. Two kinds of tibial component may be associated with the femoral component, one that is all polyethylene and one that is polyethylene metal-backed.
7)
The femoral part is manufactured from cast 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 all polyethylene tibial component is manufactured from implant grade ultra-high molecular weight polyethylene (UHMWPE) according to ISO standard 5834-2. The metal backed tibial component is composed of a polyethylene part, made from implant grade ultra-high molecular weight polyethylene (UHMWPE) according to ISO standard 5834-2, inserted in a stainless steel metal back that conforms to ISO standard 5832-1.
8) Indications
The HLS Uni Evolution prosthesis is intended for the replacement of the medial or lateral compartment of the femoro-tibial knee joint, when only one side of the knee is affected. This device is indicated in case of primary or secondary femoro-tibial arthritis. The HLS Uni Evolution prosthesis is intended for cemented use only.
2
9) Comparison table
| | | HLS Uni Evolution
prosthesis | Miller / Gallante
Precoat
Unicompartmental | Advance
Unicondylar Knee
System | Link Endo-Model
Sled Uni-Knee | SE? |
|-------------------------|---------------------------------------|-------------------------------------------------------------|---------------------------------------------------------------------|--------------------------------------------|--------------------------------------------|-----|
| Materials | Femoral
implant | Cobalt Chromium
alloy | Cobalt Chromium
alloy | Cobalt Chromium
alloy | Cobalt Chromium
alloy | YES |
| | All poly
Tibial
implant | UHMWPE | no | UHMWPE | UHMWPE | YES |
| | Metal
backed
component | UHMWPE +
Stainless steel | UHMWPE +
Titanium alloy | UHMWPE +
Titanium alloy | UHMWPE + Cobalt
Chromium alloy | NO |
| Sizes | Femoral
implant | 5 sizes in 2 thickness
(3 & 5 mm) | 7 sizes
right and left | 4 sizes | 4 sizes | YES |
| | All poly
Tibial
implant | 5 sizes in 3 thickness
(9, 11 & 13mm) | - | 4 sizes in 4 thickness
(7, 8, 9 & 10mm) | 3 sizes in 2 thickness
(11 & 13mm) | YES |
| | Metal
backed
component | 5 sizes in 3 thickness
(9, 11 & 13mm) | 5 sizes with 4
thickness
(8, 10, 12 & 14mm)
right and left | 4 sizes in 3 thickness
(10, 11 & 12mm) | 3 sizes in 4 thickness
(7, 9 11 & 13mm) | YES |
| | Method of
Fixation | cemented | cemented | cemented | cemented | YES |
| | Indications for
Use | Unicompartmental
(medial or lateral)
knee replacement | same | same | same | YES |
| | Standards
Specifications
CrCo | ISO 5832-4 | ASTM F 75 | ASTM F 75 | ISO 5832-4 | YES |
| | Standards
Specifications
UHMWPE | ISO 5834-2 | ASTM F 648 | ASTM F 648 | ISO 5834-2 | YES |
| Sterilization
method | | Gamma radiation | same | unknown | unknown | YES |
| Manufacturer | | Tornier | Zimmer, Inc | Wright Medical
Technology, Inc | Link America | - |
| K-number | | pending | K010685 | K014171 | K954186 | - |
3
Image /page/3/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three curved lines that resemble a bird in flight or a stylized representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 22 2003
Ms. Mireille Lemery Regulatory Affairs and Quality Engineer Tornier S.A. ZIRST - 161, rue Lavoisier 38330 Montbonnot France
Re: K022211 Trade/Device Name: HLS Uni Evolution Prosthesis Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: II Product Code: HSX Dated: February 20, 2003 Received: February 24, 2003
Dear Ms. Lemery:
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
4
Page 2 - Ms. Mireille Lemery
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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) 594-4639. 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 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 yours,
Sincerely yours,
Mark A Millken
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
of 1 1 Page
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
HLS Uni Evolution Device name:
Indication for use:
The HLS Uni Evolution prosthesis is intended for the replacement of the medial or lateral compartment of the femoro-tibial knee joint, when only one side of the knee is affected. This device is indicated in case of primary or secondary femoro-tibial arthritis.
The HLS Uni Evolution 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 | K022211 |
Prescription use | Yes |
OR Over-The-Counter Use | No |
(Per 21 CFR 801.109) (Optional format 1-2-96) |