CORIN UNIPOLAR MODULAR HEAD

K063791 · Corin USA · KWL · Apr 3, 2007 · Orthopedic

Device Facts

• Record ID: K063791
• Device Name: CORIN UNIPOLAR MODULAR HEAD
• Applicant: Corin USA
• Product Code: KWL · Orthopedic
• Decision Date: Apr 3, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Corin Unipolar Modular Head is indicated for hemi-arthroplasty in cemented and uncemented primary or revision femoral stem applications whose indications include procedures for patients suffering pain and disability due to osteoarthritis, rheumatoid arthritis, avascular necrosis of the femoral head, femoral neck fracture and abnormalities where the major pathology affects the femoral head, the acetabular cavity is normal and acetabular replacement is either undesirable or not required.

Device Story

Polished, truncated sphere modular head; Cobalt-Chrome alloy (ASTM F75); 40-56mm diameters; various offsets. Designed for use with compatible male-taper femoral hip stems in hemi-arthroplasty. Used by orthopedic surgeons in clinical settings for primary or revision hip procedures. Provides femoral head replacement; restores joint function; alleviates pain/disability in patients with femoral head pathology and healthy acetabulum.

Clinical Evidence

No clinical data. Substantial equivalence determined via bench testing only, including Finite Element Analysis, mechanical fatigue testing, mechanical axial pull-off, and dimensional comparison.

Technological Characteristics

Material: Cobalt-Chrome alloy (ASTM F75). Design: Polished, truncated sphere with internal female taper. Dimensions: 40-56mm diameter range. Connectivity: None (mechanical implant). Sterilization: Not specified.

Indications for Use

Indicated for patients requiring hemi-arthroplasty for pain and disability due to osteoarthritis, rheumatoid arthritis, avascular necrosis of the femoral head, femoral neck fracture, or femoral head abnormalities, provided the acetabulum is normal and acetabular replacement is not required.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.

Predicate Devices

• Johnson & Johnson ULTIMA Unipolar Modular Heads (K940190)
• Howmedica Unitrax Unipolar System (K902365)
• Howmedica Osteonics Unitrax C-Taper Neck Adjustment Sleeve (K992570)
• Osteonics Ion Implanted Femoral Bearings (K910988)

Submission Summary (Full Text)

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# APR - 3 2007

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#### 510(K) SUMMARY 3.

| 1. Applicant/Sponsor: | Corin USA<br>10500 University Center Drive<br>Suite 190<br>Tampa, Florida 33612<br>Establishment Registration No.: 1056629 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------|
| 2. Contact Person: | Kathy K. Trier, Ph.D.<br>Director Clinical and Regulatory Affairs<br>Corin USA<br>813-977-4469<br>[e-mail] |
| 3. Proprietary Name: | Corin Unipolar Modular Head |
| 4. Common Name: | Unipolar Modular Head |

5. Classification Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis (21CFR 888.3360)

6. Legally Marketed Devices to which Substantial Equivalence is claimed:

- a. Johnson & Johnson ULTIMA Unipolar Modular Heads (K940190)
- b. Howmedica Unitrax Unipolar System (K902365)
- c. Howmedica Osteonics Unitrax C-Taper Neck Adjustment Sleeve (K992570)
- d. Osteonics Ion Implanted Femoral Bearings (K910988)

### 7. Device Description:

The Corin Unipolar Modular Head is a polished, truncated sphere with a high tolerance internal female taper. It is designed to be used with a number of femoral hip stem designs which incorporate a compatible male taper. The Corin Unipolar Modular Head is manufactured from Cobalt-Chrome alloy conforming to ASTM F75 and is available in diameters ranging from 40-56mm and a variety of offsets.

- . 8. Intended Use / Indications:
The Corin Unipolat Modular Head is indicated for hemi-arthroplasty in cemented and uncemented primary or revision femoral stem applications whose indications include procedures for patients suffering pain and disability due to osteoarthritis, rheumatoid arthritis, avascular necrosis of the femoral head, femoral neck fracture and

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abnormalities where the major pathology affects the femoral head, the acetabular cavity is normal and acetabular replacement is either undesirable or not required.

- 9. Summary of Technologies/Substantial Equivalence:
The Corin Unipolar Modular Heads have the same intended use and indications and are manufactured from the same materials as the predicate Johnson & Johnson ULTIMA Unipolar Heads and Howmedica Unitrax Unipolar System. The range of diameters available falls within the range cleared for the ULTIMA and Unitrax devices. The range of offsets available falls within the range cleared for the Unitrax devices. The Corin Unipolar Modular Heads have an internal taper that is substantially equivalent to the internal taper of the Howmedica Osteonics (110w Strykcr Orthopaedics) Unitrax C-Taper Neck Adjustment Sleeves and the Osteonics (now Stryker Orthopaedics) Ion Implanted Femoral Bearings. Based on these similarities, Corin believes that the Unipolar Heads are substantially equivalent to these predicate devices.

- 10. Non-Clinical Testing:
Non-clinical testing and analysis included Finite Element Analysis, mechanical fatigue testing, mechanical axial pull-off and dimensional comparison. The results of this testing and analysis show that the Corin Unipolar Modular Head is expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate devices.

### 11. Clinical Testing:

Clinical testing was not necessary to determine substantial equivalence between the Corin Unipolar Modular Head and the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR - 3 2007

Corin USA c/o Kathy K. Trier, Ph.D. Director, Clinical and Regulatory Affairs 10500 University Center Drive Suite 190 Tampa, Florida 33612

Re: K063791

Trade/Device Name: Corin Unipolar Modular Head Regulation Number: 21 CFR 888.3360 Regulation Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWL Dated: March 13, 2007 Received; March 15, 2007

Dear Dr. Trier:

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 ericlosure) 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

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Page 2 - Kathy K. Trier, Ph.D.

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. ection provisions (000000 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 vours,

Sincerely yours,

Karlao Buehup
to

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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#### 2. INDICATIONS FOR USE

510(k) Number (if known): _ K063791

Device Name: Corin Unipolar Modular Head

Indications for Use:

The Corin Unipolar Modular Head is indicated for hemi-arthroplasty in cemented and uncemented primary or tevision femoral stern applications whose indications include procedures for patients suffering pain and disability due to osteoarthritis, theumatoid arthritis, avascular necrosis of the femoral head, femoral neck fracture and abnormalities where the major pathology affects the femoral head, the acetabular cavity is normal and acetabular replacement is either undesirable or not required.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbare Buchurs
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
K063791

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