ACCIN TOTAL KNEE SYSTEM

K081127 · Accelerated Innovation, LLC · JWH · Oct 17, 2008 · Orthopedic

Device Facts

• Record ID: K081127
• Device Name: ACCIN TOTAL KNEE SYSTEM
• Applicant: Accelerated Innovation, LLC
• Product Code: JWH · Orthopedic
• Decision Date: Oct 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ACCIN Total Knee System components are for use in total knee arthroplasty as a result of: • Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis; • Post-traumatic loss of knee joint configuration and function • Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability; • Revisions of previous unsuccessful knee replacement or other procedure. Additional indications for posteriorly stabilized components: • Ligamentous instability requiring implant bearing surfaces with increased constraint; • Absent or non-functioning posterior cruciate ligament. These devices are single use only and are intended for implantation with bone cement.

Device Story

Accin™ total knee system is a semi-constrained, cemented knee prosthesis; consists of cobalt chrome femoral components, cobalt chrome tibial tray components, and UHMWPE modular tibial bearing components. Used in total knee arthroplasty to replace diseased or damaged knee joints; restores joint function and stability. Implanted by orthopedic surgeons in a clinical/hospital setting. System includes posteriorly stabilized options for patients with ligamentous instability or absent posterior cruciate ligament. Patellar component articulates with femoral component. Single-use device; requires bone cement for fixation.

Clinical Evidence

Bench testing only. Testing performed in accordance with FDA guidance documents for total knee arthroplasty and ASTM standards F1800, F2083, and F1223. No clinical data provided.

Technological Characteristics

Materials: Cobalt chrome (femoral/tibial components), UHMWPE (modular tibial bearing). Design: Semi-constrained, cemented, polymer/metal/polymer. Standards: ASTM F1800, F2083, F1223. Sterilization: Not specified. Connectivity: N/A. Software: None.

Indications for Use

Indicated for patients requiring total knee arthroplasty due to degenerative, rheumatoid, or post-traumatic arthritis; post-traumatic joint loss; or moderate varus, valgus, or flexion deformity with stable ligamentous structures. Posteriorly stabilized components indicated for ligamentous instability or absent/non-functioning posterior cruciate ligament. For use with bone cement.

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Osteonics® Scorpio Posteriorly Stabilized Total Knee System (K962152)
• Osteonics® Scorpio Posterior Cruciate Retaining Total Knee System (K974556)
• Zimmer NexGen® Complete Knee Solution Legacy® Posterior Stabilized (LPS); LPS-Flex Fixed Bearing Femoral and Articular Surface Components (K991581)

Reference Devices

• Accin™ patellar component (K073120)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows handwritten text that appears to be a combination of alphanumeric characters and symbols. The text includes 'K081127' followed by a number sign '#' and then '1/2'. The handwriting is somewhat cursive and the characters are clearly distinguishable.

OCT 1 7 2008

## Summary of Safety and Effectiveness

| Submitter: | Michael Kvitnitsky<br>Accelerated Innovation, LLC<br>1033 US Highway 46, Suite A204<br>Clifton, NJ 07103 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | April 18, 2008 |
| Device: | Accin™ total knee system |
| Classification: | 87 JWH - Prosthesis, Knee, Patellofemoraltibial, Semi-Constrained, Cemented,<br>Polymer/Metal/Polymer - Class II (21 CFR 888.3560) |
| Predicate Device: | • Osteonics® Scorpio Posteriorly Stabilized Total Knee System (K962152)<br>• Osteonics® Scorpio Posterior Cruciate Retaining Total Knee System (K974556)<br>• Zimmer NexGen® Complete Knee Solution Legacy® Posterior Stabilized (LPS);<br>LPS-Flex Fixed Bearing Femoral and Articular Surface Components (K991581) |
| Device Description: | The Accin™ total knee system consists of a series of cobalt chrome femoral<br>components, a series of cobalt chrome tibial tray components and a series of<br>UHMWPE modular tibial bearing components. |
| Intended Use: | The ACCIN Total Knee System components are for use in total knee arthroplasty<br>as a result of:<br>• Painful, disabling joint disease of the knee resulting from degenerative<br>arthritis, rheumatoid arthritis or post-traumatic arthritis;<br>• Post-traumatic loss of knee joint configuration and function<br>• Moderate varus, valgus, or flexion deformity in which the ligamentous<br>structures can be returned to adequate function and stability;<br>• Revisions of previous unsuccessful knee replacement or other procedure.<br>Additional indications for posteriorly stabilized components:<br>• Ligamentous instability requiring implant bearing surfaces with increased<br>constraint;<br>• Absent or non-functioning posterior cruciate ligament.<br>These devices are single use only and are intended for implantation with bone |

## Comparison to Predicates:

The Accin™ total knee system consists of a series of cobalt chrome femoral components, a series of cobalt chrome tibial tray components and a series of UHMWPE modular tibial bearing components. The system is similar to the Osteonics Scorpio® Posteriorly Stabilized Total Knee System, the Osteonics Scorpio® Posterior Cruciate Retaining Total Knee System and the Zimmer LPS-Flex Fixed Bearing Femoral and Articular Surface Components. The trochlear region of the femoral component is designed to articulate with the Accin™ patellar component, previously approved under K073120. The predicate systems and the proposed system are both for use in total knee replacement surgery. Both the predicate systems and the proposed system have femoral components made from cobalt chrome and modular tibial bearing components made from UHMWPE. Both the predicate Scorpio Total Knee System and the proposed system have cobalt chrome tibial tray components.

. ...

{1}------------------------------------------------

K081122 #2/2

Accelerated Innovation, LLC has determined that the minor differences in the proposed device will not impact the safety or effectiveness of the total knee system for its intended use. Analysis has shown that the proposed device is equivalent to the predicate devices.

## Synopsis of Test Methods and Results:

Numerous tests were performed on the Accin™ total knee system. The tests performed can be found in the FDA guidance documents on total knee arthroplasty devices and ASTM Standards F1800, F2083 and F1223. Testing has shown that the Accin™ total knee system meets the requirements of the current FDA Guidance documents on total knee arthroplasty product.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

OCT 1 7 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K081127 Trade/Device Name: ACCIN Total Knce System Regulation Number: 21 CFR 888.3560 Regulation Name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Regulatory Class: Class II Product Code: JWH Dated: October 09, 2008 Received: October 10, 2008

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.

{3}------------------------------------------------

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N Wilkinson

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

Enclosure

{4}------------------------------------------------

| | Indications for Use Form |
|--|--------------------------|
| | |

| 510(k) Number (if known): | K081127 |
|---------------------------|---------|
|---------------------------|---------|

Device Name: __Accin™ total knee system

Indications for Use:

The ACCIN Total Knee System components are for use in total knee arthroplasty as a result of:

- Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid . arthritis or post-traumatic arthritis;
- Post-traumatic loss of knee joint configuration and function .
- Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be . returned to adequate function and stability;
- . Revisions of previous unsuccessful knee replacement or other procedure.

Additional indications for posteriorly stabilized components:

- Ligamentous instability requiring implant bearing surfaces with increased constraint; .
- Absent or non-functioning posterior cruciate ligament. .

These devices 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)

Restorative. and Neurologica

Page 1 of 1

Number K681127