MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS

K013211 · Exactech, Inc. · KWY · Dec 5, 2001 · Orthopedic

Device Facts

• Record ID: K013211
• Device Name: MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS
• Applicant: Exactech, Inc.
• Product Code: KWY · Orthopedic
• Decision Date: Dec 5, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3390
• 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

Modular two-piece bipolar endoprosthesis; consists of spherical cobalt chrome shell and interchangeable polyethylene liner inserts. Used in orthopedic surgery for hip replacement. Surgeon selects appropriate size from 24 shell options (38-61mm) and 4 liner options (22, 26, 28, 32mm ID). Device restores hip joint function and mobility in patients with degenerative conditions or fractures. Performance verified via bench testing including cam-out, assembly, and range of motion evaluations.

Clinical Evidence

Bench testing only. Functional testing and engineering analysis conducted to verify implant performance, including cam-out testing, assembly testing, and range of motion evaluation.

Technological Characteristics

Modular bipolar hip prosthesis. Materials: Cobalt chrome shell (ASTM F1537 or ASTM F75), polyethylene liner (ASTM F638). Sizes: 24 shell options (38-61mm), 4 liner options (22-32mm ID). Sterile (SAL 10^-6).

Indications for Use

Indicated for skeletally mature patients requiring primary hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degeneration, or proximal femoral fractures. Also indicated for ankylosing spondylitis, congenital hip dysplasia, and revision of failed reconstructions with sufficient bone stock. Contraindicated in patients with active infection, insufficient bone stock, neuromuscular disorders affecting hip control, or high risk of early failure due to weight, age, or activity level. L-Series specifically contraindicated for patients with acetabular degenerative changes or pelvic fractures.

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

• Exactech Bipolar (K905370)
• Giliberty (Zimmer)
• Bi-articular (Zimmer)
• Centrax (Howmedica)
• Conversion (Richards)
• Self-Centering (Depuy)

Submission Summary (Full Text)

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# Exactech® AcuMatch™ Integrated Hip System L-Series Bipolar Endoprosthesis

# DEC 0 5 2001

# 2 Series Biros Bigotal Enaoprossioness K Ol 32-1 (
510(k) Summary of Safety and Effectiveness K Ol 32-1 (
Special 510(k)

## Classifications / Proprietary Names:

| Classification Name: | Prosthesis, Hip, Hemi-, Femoral,<br>Metal/Polymer, Cemented or Uncemented |
|----------------------------------|---------------------------------------------------------------------------|
| Product Code: | KWY |
| C.F.R. Section: | 888.3390 |
| Device Class: | II |
| Classification Panel: | Orthopedic |
| Trade / Proprietary Model Names: | AcuMatch L-Series Bipolar Endoprosthesis |

# Legally Marketed Devices for Substantial Equivalence Comparison:

| Model | Manufacturer | 510(k) Number |
|------------------|----------------|---------------|
| Exactech Bipolar | Exactech, Inc. | #K905370 |
| Giliberty | Zimmer | |
| Bi-articular | Zimmer | |
| Centrax | Howmedica | |
| Conversion | Richards | |
| Self-Centering | Depuy | |

#### 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.

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# Exactech® AcuMatch™ Integrated Hip System L-Series Bipolar Endoprosthesis

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

# 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.

#### DESIGN

The AcuMatch L-Series Bipolar is a modular two piece device consisting of a spherical cobalt chrome shell (ASTM 1537 or ASTM F75) and interchangeable polyethylene liner inserts (ASTM F638). The metal head components come in 24 sizes (38mm through 61mm). The liner options include 22, 26, 28 and 32 mm inside diameter (1.D.) offerings. The implants are supplied sterile to an assurance level (SAL) of 10°.

## PERFORMANCE DATA

Functional testing and engineering analysis were conducted to verify that the implant performance would be adequate for anticipated in vivo load applications. This performance data includes cam-out testing, assembly testing, and a range of motion evaluation.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 5 2001

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

Re: K013211

Trade Name: AcuMatch L-Series Bipolar Endoprosthesis 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: October 26, 2001 Received: November 6, 2001

Dear Ms. Simpson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 - Ms. Lisa Simpson

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

to Mark A. Mullane

Celia M. 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.

# Indications for Use

KO13211_______________________________________________________________________________________________________________________________________________________________________ 510(k) Number:

Device Name:

AcuMatch L-Series Bipolar Endoprosthesis

## INDICATIONS

INDICATIONS
All Exactech Hip Systems are indicated for use in skeletally mature individuals r in Exaction inpost 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 the bargeon addicated 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 witters 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use **X** Over the Counter Use **__**

*Mark N Millkum*
(Division Sign-Off)
Div. General, Restorative
and Neurological Devices

K013211

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