HLS UNI EVOLUTION PROSTHESIS

K022211 · Tornier · HSX · May 22, 2003 · Orthopedic

Device Facts

• Record ID: K022211
• Device Name: HLS UNI EVOLUTION PROSTHESIS
• Applicant: Tornier
• Product Code: HSX · Orthopedic
• Decision Date: May 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3520
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Unicompartmental knee prosthesis designed to restore knee joint function and reduce pain in patients with single-compartment femoro-tibial arthritis. System comprises a metallic distal femoral resurfacing component and a tibial component (all-polyethylene or metal-backed). Used as an intermediate solution between osteotomy and total knee arthroplasty. Implanted by orthopedic surgeons in a clinical/hospital setting. Device replaces damaged joint surfaces; femoral component articulates against tibial component to facilitate joint movement. Benefits include pain reduction and restoration of joint mechanics. Fixation is achieved via bone cement.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Femoral component: Cast Cobalt-Chromium alloy (ISO 5832-4). Tibial component: UHMWPE (ISO 5834-2) or UHMWPE with stainless steel metal back (ISO 5832-1). Fixation: Cemented. Sterilization: Gamma radiation.

Indications for Use

Indicated for patients requiring replacement of the medial or lateral compartment of the femoro-tibial knee joint due to primary or secondary femoro-tibial arthritis, when only one side of the knee is affected. Intended for cemented use only.

Regulatory Classification

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).

Predicate Devices

• Miller / Gallante Precoat Unicompartmental (K010685)
• Advance Unicondylar Knee System (K014171)
• Link Endo-Model Sled Uni-Knee (K954186)

Submission Summary (Full Text)

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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

- 1) Device name

| Trade name: | HLS Uni Evolution prosthesis |
|----------------------|-----------------------------------------------------------------------------|
| Common name: | Unicompartmental Knee Prosthesis |
| Classification name: | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented,<br>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: [phone] Fax: [phone] e-mail : [e-mail]

# 3) Company contact

Tornier S.A. Mrs Mireille Lémery Regulatory affairs & Quality Engineer ZIRST - 161, rue Lavoisier 38330 Montbonnot France Tel: [phone] Fax: [phone] e-mail : [e-mail]

# 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

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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.

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### 9) Comparison table

| | | HLS Uni Evolution<br>prosthesis | Miller / Gallante<br>Precoat<br>Unicompartmental | Advance<br>Unicondylar Knee<br>System | Link Endo-Model<br>Sled Uni-Knee | SE? |
|-------------------------|---------------------------------------|-------------------------------------------------------------|---------------------------------------------------------------------|--------------------------------------------|--------------------------------------------|-----|
| Materials | Femoral<br>implant | Cobalt Chromium<br>alloy | Cobalt Chromium<br>alloy | Cobalt Chromium<br>alloy | Cobalt Chromium<br>alloy | YES |
| | All poly<br>Tibial<br>implant | UHMWPE | no | UHMWPE | UHMWPE | YES |
| | Metal<br>backed<br>component | UHMWPE +<br>Stainless steel | UHMWPE +<br>Titanium alloy | UHMWPE +<br>Titanium alloy | UHMWPE + Cobalt<br>Chromium alloy | NO |
| Sizes | Femoral<br>implant | 5 sizes in 2 thickness<br>(3 & 5 mm) | 7 sizes<br>right and left | 4 sizes | 4 sizes | YES |
| | All poly<br>Tibial<br>implant | 5 sizes in 3 thickness<br>(9, 11 & 13mm) | - | 4 sizes in 4 thickness<br>(7, 8, 9 & 10mm) | 3 sizes in 2 thickness<br>(11 & 13mm) | YES |
| | Metal<br>backed<br>component | 5 sizes in 3 thickness<br>(9, 11 & 13mm) | 5 sizes with 4<br>thickness<br>(8, 10, 12 & 14mm)<br>right and left | 4 sizes in 3 thickness<br>(10, 11 & 12mm) | 3 sizes in 4 thickness<br>(7, 9 11 & 13mm) | YES |
| | Method of<br>Fixation | cemented | cemented | cemented | cemented | YES |
| | Indications for<br>Use | Unicompartmental<br>(medial or lateral)<br>knee replacement | same | same | same | YES |
| | Standards<br>Specifications<br>CrCo | ISO 5832-4 | ASTM F 75 | ASTM F 75 | ISO 5832-4 | YES |
| | Standards<br>Specifications<br>UHMWPE | ISO 5834-2 | ASTM F 648 | ASTM F 648 | ISO 5834-2 | YES |
| Sterilization<br>method | | Gamma radiation | same | unknown | unknown | YES |
| Manufacturer | | Tornier | Zimmer, Inc | Wright Medical<br>Technology, Inc | Link America | - |
| K-number | | pending | K010685 | K014171 | K954186 | - |

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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

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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 [phone]. 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 [phone] or [phone] 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

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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) | |