ACUMATCH P-SERIES POROUS PRESS-FIT FEMORAL COMPONENT

K030236 · Exactech, Inc. · LPH · Feb 20, 2003 · Orthopedic

Device Facts

• Record ID: K030236
• Device Name: ACUMATCH P-SERIES POROUS PRESS-FIT FEMORAL COMPONENT
• Applicant: Exactech, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Feb 20, 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 Press-Fit components are intended for use in press-fit applications. Components without the optional hydroxyapatite (HA) coating may also be used with bone cement.

Device Story

AcuMatch P-Series Porous Press-Fit Femoral Component is a hip prosthesis for primary or revision hip replacement surgery. Device features trapezoidal cross-sectional geometry, distal taper, and calcar collar option; available in two offsets. Implanted by orthopedic surgeons in clinical settings to replace diseased or fractured femoral components. Titanium alloy stem with proximal porous titanium bead coating for biological fixation; optional hydroxyapatite (HA) coating available. Designed for press-fit application; non-HA coated versions compatible with bone cement. Provides structural support to restore hip joint function and mobility. Performance verified via fatigue testing to ensure durability under in vivo loading conditions.

Clinical Evidence

Bench testing only. Fatigue testing was performed to verify implant performance under anticipated in vivo loading conditions.

Technological Characteristics

Material: Titanium alloy (Ti-6Al-4V) per ASTM F1472-99. Porous coating: Titanium beads per ASTM F67-95, Grade 2. Optional hydroxyapatite (HA) coating. Design: Trapezoidal cross-section, distal taper, calcar collar option. Sterile, single-use, SAL 10^-6.

Indications for Use

Indicated for skeletally mature individuals undergoing primary hip replacement for osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative hip conditions, 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 preventing joint control, or patients whose weight, age, or activity level suggests 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

• AcuMatch P-Series Plasma Femoral Stem (K002141)
• MCS Porous Femoral Stem (K921113, K990197)
• AML Porous (K003800, K012364)
• Synergy Porous (K991485, K002996)

Submission Summary (Full Text)

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Exactech®

K030236

2320 NW 66TH COUF GAINESVILLE, FL 3265

352-377-1140 FAX [phone]

# Exactech® AcuMatch™ Integrated Hip System P-Series Porous Femoral Components

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

FEB 2 0 2003

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

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

FDA Establishment Number 1038671

Contact: Gary J. Miller, Ph.D. Exec. V.P. of Research and Development

Date: January 20, 2003

> Section 4 Page 1 of 3

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## Exactech® AcuMatch™ Integrated Hip System P-Series Porous Femoral Components

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

### Classifications / Proprietary Names:

| Classification Names: | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous, Uncemented (Femoral Component) |
|----------------------------------|------------------------------------------------------------------------------------------|
| Product Code: | LPH |
| Trade / Proprietary Model Names: | AcuMatch P-Series Porous Press-Fit Femoral Component |
| C.F.R. Section: | 888.3358 |
| Device Class: | II |
| Classification Panel: | Orthopedic |

### Legally Marketed Devices for Substantial Equivalence Comparison:

| Model | Manufacturer | 510(k) Number |
|------------------------------------------|----------------|--------------------|
| AcuMatch P-Series Plasma<br>Femoral Stem | Exactech | K002141 |
| MCS Porous<br>Femoral Stem | Exactech | K921113<br>K990197 |
| AML Porous | Depuy | K003800<br>K012364 |
| Synergy Porous | Smith & Nephew | K991485<br>K002996 |

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## Exactech® AcuMatch™ Integrated Hip System P-Series Porous Femoral Components

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

#### Device Description:

#### Indications for 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 Press-Fit components are intended for use in press-fit applications. Components without the optional hydroxyapatite (HA) coating may also be used with bone cement.

#### 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.

#### Design Features

AcuMatch P-Series Porous Femoral Stems are composed of titanium alloy (Ti-6A1-4V) conforming to ASTM F1472-99. The stems have a trapezoidal cross-sectional geometry, distal taper, and calcar collar option. There are two offset options available. The porous bead coating on the proximal portion of the stem is composed of titanium beads meeting the specifications of ASTM F67-95, Grade 2. An optional hydroxyapatite (HA) coating is also available. The products are provided as sterile, single use only with a sterility assurance level (SAL) of 10-0.

#### Substantial Equivalency

AcuMatch P-Series Porous stems are substantially equivalent to other femoral components, most notably the Exactech MCS and P-Series Plasma stems. The predicate and proposed devices share common design features and material properties. Fatigue testing was performed to verify that the implant performance would be adequate for anticipated in vivo loading.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 0 2003

Ms. Lisa Simpson Sr. Regulatory Representative Exactech 2320 NW 66" Court Gainesville, FL 32653

Re: K030236

Trade/Device Name: AcuMatch P-Series Porous Press-Fit Femoral Component Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: January 20, 2003

Received: January 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. Iisting 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 mav 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), 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 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,

Mark n Milleson

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® AcuMatch™ Integrated Hip System P-Series Porous Press-Fit Femoral Components

### Indications for Use

510(k) Number:

K030436

Device Name:

AcuMatch P-Series Porous Press-Fit Femoral Stem

#### Indications for 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 Press-Fit components are intended for use in press-fit applications. Components without the optional hydroxyapatite (HA) coating may also be used with bone cement.

#### 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

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