EXACTECH 12/14 ALUMINA FEMORAL HEADS 36 MM

K051682 · Exactech, Inc. · LZO · Jul 19, 2005 · Orthopedic

Device Facts

• Record ID: K051682
• Device Name: EXACTECH 12/14 ALUMINA FEMORAL HEADS 36 MM
• Applicant: Exactech, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Jul 19, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.

Device Story

Exactech 12/14 Alumina Femoral Heads are orthopedic prosthetic components used in hip replacement surgery. This modification introduces 36 mm diameter femoral heads in three neck lengths (-3.5, 0, +3.5 mm). The device is implanted by orthopedic surgeons in a clinical/hospital setting during primary or revision hip arthroplasty. The femoral head articulates with the acetabular component to restore hip joint function and mobility. Clinical benefit is derived from replacing damaged or diseased bone/joint surfaces, thereby reducing pain and improving patient mobility. The device is intended for use in skeletally mature patients.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified through engineering evaluations and empirical testing to ensure adequacy for in vivo use.

Technological Characteristics

Alumina ceramic femoral head components. 12/14 taper interface. 36 mm outside diameter. Available in three neck lengths (-3.5, 0, +3.5 mm). Semi-constrained prosthesis design. Class II device (21 CFR 888.3353).

Indications for Use

Indicated for skeletally mature individuals requiring primary hip replacement or revision due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degeneration, proximal femoral fractures, ankylosing spondylitis, congenital hip dysplasia, or fusion restoration. Contraindicated in patients with active infection, insufficient bone stock, neuromuscular disorders preventing joint control, or patients where weight, age, or activity level suggests early system failure.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

• Exactech 12/14 Alumina Femoral Heads (K032964)

Submission Summary (Full Text)

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

**Exactech**

JUL 1 9 2005

<051682
page 1 of
2324 NW 56TH COURT
GAINESVILLE, FL 32653
352-377-1140

350

Exactech® AcuMatch 12/14 Press-Fit Femoral Stems

510(k) Summary of Safety and Effectiveness Special 510(k)

Exactech® Inc. Sponsor: 2320 N.W. 66th Court Gainesville, Florida 32653

> (352) - 377 - 1140 Phone: (352) - 378 - 2617 Fax:

FDA Establishment Number 1038671

Bennie Gladdish Contact: Hip Systems Manager/Principal Engineer

June 20, 2005 Date:

Rev. 06/20/05

Section 4 Page 1 of 2

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page of
2526 NW 66TH COURT
GAINESVILLE, FL 3265

### Exactech® AcuMatch 12/14 Press-Fit Femoral Stems

### 510(k) Summary of Safety and Effectiveness Special 510(k)

#### Trade or proprietary or model name(s):

Exactech 12/14 Alumina Femoral Heads

### Information on devices to which substantial equivalence is claimed:

| 510(k)<br>Number | Trade or Proprietary or Model Name | Manufacturer |
|------------------|--------------------------------------|----------------|
| #K032964 | Exactech 12/14 Alumina Femoral Heads | Exactech, Inc. |

#### INDICATIONS

All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.

#### Special 510(k) Modifications

- Addition of 36 mm outside diameter size femoral head components in three different . head lengths (-3.5, 0 +3.5 mm)
#### Conclusion:

Testing and engineering evaluations were conducted to verify that the performance of the new Exactech AcuMatch 12/14 Press-Fit Femoral Stem components would be adequate for anticipated in vivo use. This includes empirical testing and engineering analyses. Based on successful results we conclude that the proposed devices are substantially equivalent to Exactech's predicate femoral stems.

Rev. 06/20/05

Section 4 Page 2 of 2

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing the body and wings.

Public Health Service

JUL 1 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Maritza Elias Regulatory Representative Exactech, Inc. 2320 N.W. 66th Court Gainesville, Florida 32653

+

Re: K051682

Trade/Device Name: Exactech 12/14 Alumina Femoral Heads 36 mm Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZ0 Dated: June 20, 2005 Received: June 23, 2005

Dear Ms. Elias:

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 - Ms. Maritza Elias

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. ・。 ﺘﺸﺘﺮ ﺗﺤ

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/dsma/dsmamain.html

Sincerely yours.

Signature

Miriam C. Provost, Ph.D Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Exactech®, Inc.

### Exactech 12/14 Alumina Femoral Heads 36 mm

## Indications for Use

1081682

510(k) Number:

#### INDICATIONS

All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.

#### CONTRAINDICATIONS

Exactech Hip Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, in neuromuscular disorders that do not allow control of the hip joint, and in patients whose weight, age, or activity level would cause the surgeon to expect early failure of the system.

Prescription Use

X =

or

Over the Counter Use \$\mu_2\$

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
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