EXACTECH 12/14 ALUMINA FEMORAL HEAD; EXACTECH ACUMATCH M-SERIES 12/14 NECK SEGMENTS

K032964 · Exactech, Inc. · LPH · Nov 13, 2003 · Orthopedic

Device Facts

• Record ID: K032964
• Device Name: EXACTECH 12/14 ALUMINA FEMORAL HEAD; EXACTECH ACUMATCH M-SERIES 12/14 NECK SEGMENTS
• Applicant: Exactech, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Nov 13, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• 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. AcuMatch M-Series 12/14 Neck Segments and Exactech 12/14 Alumina Femoral Heads are intended to be used in press-fit and cemented applications.

Device Story

Device consists of alumina ceramic femoral heads and metal neck segments for hip arthroplasty; used in press-fit or cemented applications. Alumina heads replace zirconia predecessors; neck segments feature modified femoral stem cone, neck geometry, and through-hole diameter. Components integrate into hip replacement systems to restore joint function. Operated by orthopedic surgeons in clinical settings. Output is a mechanical prosthetic interface; clinical decision-making relies on surgeon assessment of patient bone stock and pathology. Benefits include restoration of mobility and treatment of degenerative hip conditions.

Clinical Evidence

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

Technological Characteristics

Alumina femoral heads (CeramTec BIOLOX forte); metal neck segments. European 12/14 taper geometry. Press-fit or cemented application. No software or electronic components.

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 whose weight, age, or activity level risks early system failure.

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

• Exactech Zirconia Ceramic Femoral Head (K914574)
• Exactech Zirconia Ceramic Femoral Head (K931617)
• Exactech AcuMatch M-Series Femoral Stems (K993736)
• Exactech AcuMatch M-Series Femoral Stems (K010120)

Submission Summary (Full Text)

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# NOV 1 3 2003

2320 NW 661H COUF : GAINESVILLE, FL 32653

352-377-1140 FAX [phone]

K032964

## Exactech® Alumina Femoral Heads 12/14 M-Series Neck Segments

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

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

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

FDA Establishment Number 1038671

Gary J. Miller Contact: Exec. V.P. of Research & Development

October 22, 2003 Date:

rev. 10/22/03

EXACTECH exist to inque the quility of included by munitive ad integendere. Ne to this through inovative ideos, high-quothy moves education and comminsent to serve.

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## Exactech® Alumina Femoral Heads 12/14 M-Series Neck Segments

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

| Trade / Proprietary Name: | Exactech |
|---------------------------|----------------------------------------------------------------------------------------------------|
| Model Name: | 12/14 Alumina Femoral Head |
| Classification Name: | Prosthesis, Hip, Semi-Constrained,<br>Metal/Ceramic/Polymer, Cemented<br>or Non-Porous, Uncemented |
| Product Code: | LZO |
| C.F.R. Section: | not specified |
| Device Class: | II |
| Classification Panel: | Orthopedic |

| Trade / Proprietary Name: | Exactech AcuMatch |
|---------------------------|-------------------------------------------------------------------------|
| Model Name: | M-Series 12/14 Neck Segment |
| Name: | Prosthesis, Hip, Semi-Constrained, Metal/Polymer,<br>Porous, Uncemented |
| Product Code: | LPH |
| C.F.R. Section: | 888.3358 |

## Legally Marketed Devices for Substantial Equivalence Comparison:

| Exactech Zirconia Ceramic Femoral Head | #K914574 |
|------------------------------------------|----------|
| | #K931617 |
| Exactech AcuMatch M-Series Femoral Stems | |
| (Neck Segments) | #K010120 |

Section 4 Page 2 of 4

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## Exactech® Alumina Femoral Heads 12/14 M-Series Neck Segments

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

#### Device Description:

#### 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.

AcuMatch M-Series 12/14 Neck Segments and Exactech 12/14 Alumina Femoral Heads are intended to be used in press-fit and cemented applications.

#### 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. The L-Series unipolar and bipolar endoprostheses are also contraindicated for use in patients with evidence of degenerative changes in the acetabulum and/or pelvic fractures.

#### Exactech 12/14 Alumina Femoral Heads

This Special 510(k) application supports design changes to the proposed BIOLOX® forte 12/14 Ceramic Femoral Heads relative to Exactech's predicate Zirconia Ceramic Femoral Heads (#K914574, #K931617). The modifications include a change in the ceramic material composition from zirconia to alumina and a change in the taper geometry from a proprietary 11/13 design to a European 12/14 design.

The proposed Ceramic Femoral Heads are composed of CeramTec BIOLOX® forte alumina material and have a European 12/14 bore design. The material properties of BIOLOX® forte are described in FDA Master Files MAF-197, MAF-746, and MAF-747.

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## Exactech® Alumina Femoral Heads 12/14 M-Series Neck Segments

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

#### AcuMatch M-Series 12/14 Neck Segments

This Spccial 510(k) application supports modification of the AcuMatch M-Series neck segments (#K993736, #K010120). Modifications were made to the femoral stem cone design, neck geometry and through-hole diameter. The material composition, surface finish, neck angle, neck length and metaphyseal taper connection are unchanged.

#### Conclusion:

Testing and engineering evaluations were conducted to verify that the performance of the new 12/14 alumina heads and the 12/14 neck segments would be adequate for anticipated in vivo loading. Based on successful results we conclude that the proposed devices are substantially equivalent Exactech's predicate devices.

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circle 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.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 2003

Ms. Lisa Simpson Senior Regulatory Representative Exactech, Inc. 2320 NW 66th Court Gainesville, Florida 32653

Re: K032964 Trade/Device Name: Exactech 12/14 Alumina Femoral Head, Exactech AcuMatch M-Series 12/14 Neck Segment Regulation Number: 21 CFR 888.3358, 21 CFR 888.3353 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis, Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LPH, LZO Dated: October 22, 2003 Received: October 23, 2003

Dear Ms. Simpson:

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

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#### Page 2 - Ms. Lisa Simpson

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.

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 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,

for Mark A. Mellema

Celia Witten, Ph.D., M.D 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.

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# Exactech 12/14 Alumina Femoral Head Exactech AcuMatch M-Series 12/14 Neck Segment

## Indications for Use

510(k) Number:

K032964

### 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.

AcuMatch M-Series 12/14 Neck Segments and Exactech 12/14 Alumina Fcmoral Heads are intended to be used in press-fit and cemented applications.

#### CONTRAINDICATIONS

Exactech Hip Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion 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.

Please do not write below this line - use another page if needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Al or N Over the Counter Use
Division Sign Off

Estorative

spinal Neurological Devices

rev. 10/22/03

(k) Number

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