ACCIN UNI-KNEE SYSTEM

K060670 · Accin Corporation · HSX · Jun 2, 2006 · Orthopedic

Device Facts

• Record ID: K060670
• Device Name: ACCIN UNI-KNEE SYSTEM
• Applicant: Accin Corporation
• Product Code: HSX · Orthopedic
• Decision Date: Jun 2, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3520
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ACCIN UNI-Knee System components are for use in Unicompartmental knee arthroplasty as a result of: Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis; Correction of functional deformities; Revision of previous unsuccessful unicompartmental knee replacement or other procedure; As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis. These components are single use only and are intended for implantation with bone cement.

Device Story

ACCIN UNI-Knee System is a cemented, non-constrained, metal/polymer unicompartmental knee prosthesis. Components include cobalt chrome femoral component and tibial tray, plus polyethylene tibial insert. Device implanted by orthopedic surgeons during unicompartmental knee arthroplasty to address joint disease, functional deformities, or revision needs. Provides mechanical replacement of knee joint surfaces to reduce pain and restore function. Single-use device.

Clinical Evidence

Bench testing only. No clinical data provided. Testing performed in accordance with FDA guidance document for Class II Special Controls for Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses.

Technological Characteristics

Materials: Cobalt chrome (femoral/tibial components), polyethylene (tibial insert). Design: Non-constrained, cemented, metal/polymer unicompartmental knee prosthesis. Regulatory Class II, Product Code HSX. Single-use.

Indications for Use

Indicated for patients requiring unicompartmental knee arthroplasty due to moderately disabling osteoarthritis or post-traumatic arthritis, functional deformities, or revision of prior unsuccessful unicompartmental procedures. Also indicated as an alternative to tibial osteotomy for unicompartmental osteoarthritis.

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

• EIUS Unicompartmental Knee System (K033769 and K992287)
• Stelkast Unicondylar Knee System (K0032824)
• Zimmer Unicompartmental Knee System (K033363)

Submission Summary (Full Text)

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### Summary of Safety and Effectiveness

| Submitter: | Michael Kvitnitsky<br>ACCIN Corporation<br>1033 US Highway 46, Suite A204<br>Clifton, NJ 07103 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | February 18, 2006 |
| Device: | ACCIN UNI-Knee System |
| Classification: | 87 HSX - Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal<br>Polymer, 21 CFR 888.3520, Class II |
| Predicate Device: | EIUS Unicompartmental Knee System - K033769 and K992287<br>Stelkast Unicondylar Knee System - K0032824<br>Zimmer Unicompartmental Knee System - K033363 |
| Device Description: | The ACCIN UNI-Knee System consists of Cobalt Chrome femoral component and<br>tibial tray and a polyethylene tibial insert. |
| Intended Use: | The ACCIN UNI-Knee System components are for use in Unicompartmental knee<br>arthroplasty as a result of:<br>Moderately disabling joint disease of the knee resulting from painful osteoarthritis<br>or post traumatic arthritis; Correction of functional deformities; Revision of previous unsuccessful unicompartmental knee replacement or other<br>procedure; As an alternative to tibial osteotomy in patients with unicompartmental<br>osteoarthritis. JUN - 2 2006 |

These components are single use only and are intended for implantation with bone cement.

### Comparison to Predicates:

The ACCIN UNI-Knee system consists of cobalt chrome femoral and tibial components and a polyethylene insert. The device is similar to the Stelkast Unicondylar Knee System, the EUIS Unicompartmental Kryle system and the Zimmer High Flex Unicompartmental Knee System. All three devices are for use in unicompartmental knee replacement. The Zimmer product and the proposed ACCIN device have a metal tibial tray and a UHMWPE tibial insert; whereas the EUIS system and the Stelkast system have an all-polyethylene tibia.

ACCIN Corporation has determined that the minor differences in the proposed device will not impact the safety or effectiveness of the unicompartmental knee system for its intended use. Testing has shown that the proposed device is equivalent to the predicate device.

## Synopsis of Test Methods and Results:

Tests were performed on the ACCIN UNI-Knee System as compared to the Stelkast Unicondylar Knee System. The tests performed can be found in the guidance document entitled "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial MetalPolymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA." The results provided in the testing section of this submission demonstrate that the proposed ACCIN UNI-Knee System is equivalent to the predicate device Stelkast Unicondylar Knee System.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three curved lines representing its wings. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 2 2006

ACCIN Corporation % Mr. Michael Kvitnitsky 1033 US Highway 46 East Suite A204 Clifton, New Jersey 07013

Re: K060670

Trade/Device Name: ACCIN UNI-Knee System 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: March 06, 2006 Received: March 14, 2006

Dear Mr. Kvitnitsky:

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.

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

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Page 2 – Mr. Michael Kvitnitsky

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 (240)-276-0120. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Hubert Lerner

for

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 5 -- Mr. Michael Kvitnitsky

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OC Numbers:

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| Division of Enforcement A | 240-276-0115 |
|-----------------------------------------------------------|--------------|
| Dental, ENT and Ophthalmic Devices Branch | 240-276-0115 |
| OB/GYN, Gastro. & Urology Devices Branch | 240-276-0115 |
| General Hospital Devices Branch | 240-276-0115 |
| General Surgery Devices Branch | 240-276-0115 |
| Division of Enforcement B | 240-276-0120 |
| Cardiovascular & Neurological Devices Branch | 240-276-0120 |
| Orthopedic, Physical Medicine & Anesthesiology Devices Br | 240-276-0120 |

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## Indications for Use Form

510(k) Number (if known):_

Device Name: ACCIN UNI-Knee System

Indications for Use:

Indications for Use:

The ACCIN UNI-Knee System components are for use in Unicompartmental knee arthroplasty as a result of:

- Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post . traumatic arthritis;
- Correction of functional deformities; .
- Revision of previous unsuccessful unicompartmental knee replacement or other . procedure:
- As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis. .

These components are single use only and are intended for implantation with bone cement.

Prescription Use _ × (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

2

Herbert Lerner

Division of General, Restorative, and Neurological Devices

**510(k) Number** k060670

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