ACCIN UNI-KNEE SYSTEM

K063782 · Accin Corporation · HSX · Jan 19, 2007 · Orthopedic

Device Facts

• Record ID: K063782
• Device Name: ACCIN UNI-KNEE SYSTEM
• Applicant: Accin Corporation
• Product Code: HSX · Orthopedic
• Decision Date: Jan 19, 2007
• Decision: SESE
• Submission Type: Special
• 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 unicompartmental knee prosthesis; consists of cobalt chrome femoral component, tibial tray, and polyethylene tibial insert. Line extension adds 11mm, 13mm, and 14mm tibial bearing components to existing 8mm-10mm range; total thickness range 8mm-14mm. Intended for implantation with bone cement in unicompartmental knee arthroplasty. Used by orthopedic surgeons in clinical/surgical settings to replace damaged joint surfaces; restores joint function; reduces pain associated with osteoarthritis or post-traumatic arthritis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cobalt chrome femoral and tibial components; polyethylene tibial insert. Non-constrained, cemented prosthesis. Dimensions: tibial bearing thickness range 8mm to 14mm in 1mm increments. 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

• Accin UNI-Knee System (K060670)
• Zimmer Unicompartmental Knee System (K033363)

Submission Summary (Full Text)

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K06 3782 Page 1/2

JAN 1 9 2007

ACCIN UNI-Knee System Line Extension Premarket Notification Submission - Special 510(k)

### Summary of Safety and Effectiveness

| Submitter: | Michael Kvitnitsky<br>ACCIN Corporation<br>1033 US Highway 46, Suite A204<br>Clifton, NJ 07103 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | December 19, 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: | Accin UNI-Knee System - K060670<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; |

- l Correction of functional deformities:
- Revision of previous unsuccessful unicompartmental knee replacement or other l procedure;
- r 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.

#### Comparison to Predicates:

The ACCIN UNI-Knee system consists of cobalt chrome femoral and tibial components and a polyethylene insert. The Accin UNI-Knee additional tibia bearing components are equivalent to the currently marketed Accin UNI-Knee tibia bearing components with the exception of thickness. The Accin UNI-Knee additional tibia bearing components will make the bearing thickness range (8mm to 14mm) equivalent to that of the currently marketed Zimmer Unicompartmental Knee System.

## Description of Device Modification:

This submission is intended to address a line extension of the Accin UNI-Knee system. The line extension includes additional tibia bearing components 11mm, 13mm and 14mm, making the tibia bearing thickness range 8mm to 14mm, in 1mm increments. No other changes or additions are being made.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and tail. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 9 2007

Accin Corporation % Mr. Michael Kvitnitsky President 1033 US Highway 46 East Suite A204 Clifton, New Jersey 07103

Re: K063782

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: December 19, 2006 Received: December 26, 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.

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Page 2 - Mr. Michael Kvitnitsky

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 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 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,

Barbara Buell
TN

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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# 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 __ X (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)

Aarbaue Breur
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

**510(k) Number** K063782

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