ACCIN UNIPOLAR HEAD SYSTEM

K080539 · Accelerated Innovation, LLC · JDI · Jun 2, 2008 · Orthopedic

Device Facts

• Record ID: K080539
• Device Name: ACCIN UNIPOLAR HEAD SYSTEM
• Applicant: Accelerated Innovation, LLC
• Product Code: JDI · Orthopedic
• Decision Date: Jun 2, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Accin™ Unipolar Head is intended to be implanted for use in the reconstruction of the femoral portion of severely disabled and / or very painful hip joints resulting from: Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis; Avascular Necrosis. The device is only for use where sufficient sound bone to seat the prosthesis is present and for use with the Accin Hip Stems.

Device Story

The Accin™ Unipolar Head is a modular cobalt chrome endo-prosthesis femoral head. It is designed for surgical implantation to reconstruct the femoral portion of the hip joint. The device is intended for use in patients suffering from severe hip joint disability or pain caused by osteoarthritis, rheumatoid arthritis, traumatic arthritis, or avascular necrosis. It must be used in conjunction with Accin Hip Stems and requires sufficient sound bone for proper seating. The device is implanted by an orthopedic surgeon in a clinical/hospital setting. It functions as a mechanical replacement component to restore joint function and alleviate pain.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Cobalt chrome. Form factor: Modular femoral head. Intended for use with Accin Hip Stems. Cemented prosthesis.

Indications for Use

Indicated for patients with severely disabled or painful hip joints due to osteoarthritis, rheumatoid arthritis, traumatic arthritis, or avascular necrosis. Contraindicated if insufficient sound bone is present to seat the prosthesis.

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Stelkast Endo Prosthesis Femoral Head (K952461)

Submission Summary (Full Text)

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Accin™ Unipolar Head Premarket Notification Submission - 510(k)

JUN - 2 2008

## Summary of Safety and Effectiveness

Michael Kvitnitsky Submitter: Accelerated Innovation, LLC 1033 US Highway 46, Suite A204 Clifton, NJ 07103

- Date Prepared: February 3, 2008
- Accin™ Unipolar Head Device:

87 JDI - Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented, 21 Classification: CFR 888.3350. Class II

Stelkast Endo Prosthesis Femoral Head - K952461 Predicate Device:

Device Description: The Accin™ Unipolar Head System consists of a cobalt chrome modular endo prosthesis femoral head.

- The Accin™ Unipolar Head is intended to be implanted for use in the Intended Use: reconstruction of the femoral portion of severely disabled and / or very painful hip joints resulting from:
- Osteoarthritis: .
- Rheumatoid Arthritis; .
- Traumatic Arthritis; �
- Avascular Necrosis ●

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

## Comparison to Predicates:

The Accin™ Unipolar Head consists of cobalt chrome femoral head. The device is equivalent to the Stelkast Unipolar Head System, which also has the same component manufactured from the same material.

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

JUN - 2 2008

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Accin Corporation % Mr. Michael Kvitnitsky Chief Operating Officer 1033 U.S. Highway 46 East Suite A204 Clifton, New Jersey 07013

JUN - 2 2008

Re: K080539

Trade/Device Name: Accin™ Unipolar Head System Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulation Class: Class II Product Code: JDI Dated: May 9, 2008 Received: May 12, 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

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Page 2 - Mr. Michael Kvitnitsky

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 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 (240)- 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240)- 276-3464. 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 Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millman

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

K080539 510(k) Number (if known):

Device Name: Accin™ Unipolar Head (Modular Endo Head)

Indications for Use:

The Accin™ Unipolar Head is intended to be implanted for use in the reconstruction of the femoral portion of severely disabled and / or very painful hip joints resulting from:

- Osteoarthritis; ◆
- Rheumatoid Arthritis; .
- Traumatic Arthritis; �
- Avascular Necrosis; .

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

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)

Neil R. P. Leslie, M.D.

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Division of General, Restorative. and Neurological Devices

**510(k) Number** K080539