ACCIN BIPOLAR HEAD SYSTEM

K080647 · Accelerated Innovation, LLC · KWY · Jul 8, 2008 · Orthopedic

Device Facts

• Record ID: K080647
• Device Name: ACCIN BIPOLAR HEAD SYSTEM
• Applicant: Accelerated Innovation, LLC
• Product Code: KWY · Orthopedic
• Decision Date: Jul 8, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Accin™ Bipolar Head components are intended to be implanted to replace a portion of the hip for: Fractures of the proximal femur; . Non-unions of proximal femoral neck fractures; . Aseptic necrosis of the femoral head; . Osteo-rheumatoid and post traumatic arthritis of the hip with minimal . distortion of the acetabulum; and . Salvage of failed total hip arthroplasty. . The device is only for use where sufficient sound bone to seat the prosthesis is present and for use with the Accin Hip System components.

Device Story

Accin™ Bipolar Head System is a hip hemiarthroplasty prosthesis. Device consists of cobalt chrome femoral head, preassembled polyethylene insert, and polyethylene snap ring. Designed for surgical implantation to replace femoral head portion of hip joint. Used by orthopedic surgeons in clinical settings. Device functions as mechanical replacement for damaged femoral head, articulating within acetabulum. Provides structural support for patients with fractures, necrosis, or arthritis. Intended for use with Accin Hip System components where sufficient bone stock is available for seating.

Clinical Evidence

Bench testing only.

Technological Characteristics

Cobalt chrome femoral head; polyethylene insert; polyethylene snap ring. Mechanical articulation. Class II device (21 CFR 888.3390).

Indications for Use

Indicated for patients requiring hip hemiarthroplasty due to proximal femur fractures, non-unions of femoral neck fractures, aseptic necrosis of the femoral head, or osteo-rheumatoid/post-traumatic arthritis with minimal acetabular distortion. Also indicated for salvage of failed total hip arthroplasty. Requires sufficient sound bone for seating. Contraindicated if insufficient bone stock exists.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.

Predicate Devices

• Stelkast Bipolar Head System (K981451)

Submission Summary (Full Text)

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## Summary of Safety and Effectiveness

| Submitter: | Michael Kvitnitsky<br>Accelerated Innovation, LLC<br>1033 US Highway 46, Suite A204<br>Clifton, NJ 07103 | JUL - 8 2008 |
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Date Prepared: February 28, 2008

Accin™ Bipolar Head Device:

87 KWY - Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented or Classification: Uncemented - 21 CFR 888.3390, Class II

Stelkast Bipolar Head System - K981451 Predicate Device:

Device Description: The Accin™ Bipolar Head System consists of a cobalt chrome femoral head with a preassembled polyethylene insert and a snap ring that locks the head into the insert.

- The Accin™ Bipolar Head components are intended to be implanted to Intended Use: replace a portion of the hip for:
- Fractures of the proximal femur; .
- Non-unions of proximal femoral neck fractures; .
- Aseptic necrosis of the femoral head; .
- Osteo-rheumatoid and post traumatic arthritis of the hip with minimal . distortion of the acetabulum; and
- Salvage of failed total hip arthroplasty. .

The device is only for use where sufficient sound bone to seat the prosthesis is present and for use with the Accin Hip System components.

## Comparison to Predicates:

The Accin™ Bipolar Head consists of cobalt chrome femoral head with a preassembled polyethylene insert and polyethylene snap ring. The device is equivalent to the Stelkast Bipolar Head System, which also has the same components manufactured from the same materials.

Accin™ has determined that any differences in the proposed device will not impact the safety or effectiveness of the bipolar system for its intended use. Testing has shown that the proposed device is equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 8 2008

Accelerated Innovation, LLC % Mr. Michael Kvitnitsky Chief Operating Officer 1033 US Highway 46 East, Suite A204 Clifton, NJ 07013

Re: K080647 Trade/Device Name: ACCINTM Bipolar Head System Regulation Number: 21 CFR 888.3390 Regulation Name: Hip joint femoral (hemi hip) metal/polymer cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWY Dated: June 6, 2008 Received: June 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.

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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 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 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 H. Wilkerson

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™ Bipolar Head

Indications for Use:

The Accin™ Bipolar Head components are intended to be implanted to replace a portion of the hip for:

- Fractures of the proximal femur; .
- . Non-unions of proximal femoral neck fractures;
- Aseptic necrosis of the femoral head; .
- Osteo-rheumatoid and post traumatic arthritis of the hip with minimal . distortion of the acetabulum; and
- . Salvage of failed total hip arthroplasty.

The device is only for use where sufficient sound bone to seat the prosthesis is present and for use with the Accin Hip System components.

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)

Charles MelinD for MYW
Division Sign Off

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and Neurological Devices

**510(k) Number** K080647