ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FIT

K002141 · Exactech, Inc. · LWJ · Aug 16, 2000 · Orthopedic

Device Facts

• Record ID: K002141
• Device Name: ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FIT
• Applicant: Exactech, Inc.
• Product Code: LWJ · Orthopedic
• Decision Date: Aug 16, 2000
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

AcuMatch Press-Fit Femoral Components are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, congenital hip dysplasia, 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 the AcuMatch Integrated Hip System are also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is present and to restore mobility resulting from previous fusion. AcuMatch Press-Fit Femoral Components are intended to be used in press fit applications. Components without the optional hydroxyapatite (HA) coating may also be used in cemented applications.

Device Story

AcuMatch Press-Fit Femoral Components are orthopedic implants used in total hip arthroplasty. The system consists of titanium alloy (Ti-6Al-4V) femoral stems with trapezoidal cross-sectional geometry, secondary distal tapers, and optional calcar collars. Components are available with or without hydroxyapatite (HA) or plasma coatings. The device is implanted by an orthopedic surgeon in a clinical/OR setting. The surgeon performs a press-fit insertion into the femoral canal; non-HA coated versions may also be used with bone cement. The implant replaces the femoral head and neck to restore joint function and mobility. Clinical benefit includes pain relief and improved hip function for patients with degenerative joint disease or fractures. The device is provided sterile via gamma radiation.

Clinical Evidence

Bench testing only. Performance verified via fatigue testing of production-quality parts and rotating beam fatigue tests of wrought and forged materials. Results compared against predicate MCS design, demonstrating superior fatigue performance. No clinical trial data presented.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V). Design: Trapezoidal cross-sectional geometry, secondary distal tapers, optional calcar collars. Coatings: Optional hydroxyapatite (HA) or plasma. Sterilization: Gamma radiation (Cobalt 60), 25-37 kGy, SAL 10^-6. Packaging: PETG trays, Tyvek lids, LD45 foam inserts.

Indications for Use

Indicated for skeletally mature patients undergoing primary total hip replacement for osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, congenital hip dysplasia, post-traumatic degenerative hip conditions, or proximal femoral fractures. Also indicated for revision of failed reconstructions with sufficient bone stock and to restore mobility after previous fusion. Contraindicated in patients with active infection, insufficient bone stock, neuromuscular disorders preventing hip joint control, or patients where weight, age, or activity level suggests early system failure.

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

• Exactech MCS femoral components (K921113)
• Exactech MCS/HA femoral components (K990197)

Reference Devices

• Perfecta (Wright Medical Technology)
• Synergy HA (Smith & Nephew)
• Synergy Press-Fit (Smith & Nephew)
• Secur-Fit HA (Osteonics)
• APR Fully Textured (Sulzer)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the word "Exactech" in white letters on a black background. The word is in a bold, sans-serif font. To the left of the word is a white circle with a gap in the upper right quadrant. The image is simple and clean, with a focus on the company name.

Koo214/

2320 NW 66TH COURT GAINESVILLE, FL 32653

#### 352-377-1140 FAX [phone]

## AUG 1 6 2000

# Exactech® AcuMatch™ Integrated Hip System Press-Fit Femoral Components

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

Sponsor:

Exactech® Inc. 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. V.P. of Research and Development

Date:

July 14, 2000

Section 4 Page 1 of 5

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

LWJ

II

not specified

#### Classifications / Proprietary Names:

Classification Name:

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented (Femoral Component)

Trade / Proprietary Model Names:

AcuMatch P-Series Press-Fit Plasma AcuMatch P-Series Press-Fit AcuMatch L-Series Press-Fit

Product Code:

C.F.R. Section:

Device Class:

Classification Panel: Orthopedic

Classification Name:

Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calcium-Phosphate (Femoral Component)

Trade / Proprietary Model Names:

AcuMatch P-Series Press-Fit Plasma / HA AcuMatch P-Series Press-Fit / HA AcuMatch L-Series Press-Fit / HA

Product Code:

not specified

Device Class:

C.F.R. Section:

II

MEH

Classification Panel: Orthopedic

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

### Legally Marketed Devices for Substantial Equivalence Comparison:

The Exactech AcuMatch Press-Fit Stems are made of similar materials and are of a similar design to other legally marketed femoral components, most notably the Exactech MCS femoral components:

| Model | Manufacturer | 510(k) Number | Product Code |
|-----------------------|------------------------------|---------------|--------------|
| MCS | Exactech | 921113 | LPH |
| MCS/HA | Exactech | 990197 | MEH |
| | | | |
| Perfecta | Wright Medical<br>Technology | ---------- | ---------- |
| Synergy HA | Smith & Nephew | ---------- | ---------- |
| Synergy Press-Fit | Smith & Nephew | ---------- | ---------- |
| Secur-Fit HA | Osteonics | ---------- | ---------- |
| APR Fully<br>Textured | Sulzer | ---------- | ---------- |

#### Device Description

### Indications for Use:

AcuMatch Press-Fit Stems are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, dhenmatoid arthritis, osteonecrosis, ankylosing spondylitis, congenital hip dysplasia, post-taunatio degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred tratment. Components of AcuMatch Integrated Hip Systems are also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is prased ond to restore mobility resulting from previous fusion.

{3}------------------------------------------------

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

AcuMatch Press-Fit Femoral Components are intended to be used in press-fit applications. Components without the hydroxyapatite (HA) coating may also be used with bone cement.

#### Contraindications:

AcuMatch Press-Fit Femoral Components 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 indications/contraindications for use for the proposed AcuMatch Press-Fit Femoral Components are identical to those of our predicate Exactech MCS and MCS/HA Femoral Components (#K921113,#K990197).

| Material | Composition |
|---------------------|-----------------------------------|
| Inner / Outer Trays | PETG - 0.040" thickness |
| Tray Lids | Spun-Bonded Olefin - Tyvek® |
| Inserts | Medium grade LD45 Foam |
| Box | Heavy weight cardboard |
| Outer Shrink-Wrap | Clear, Light-Weight Plastic |
| Shipping Cartons | Heavy-weight Corrugated Cardboard |

Packaging Materials:

Utilization and implantation instructions are included in the package insert provided with each product. The name, size, dimension, material, lot, serial number and sterility status are indicated on the labeling.

Sterilization Specifications:

Method: Gamma radiation (Cobalt 60 source) Dose: 25 - 37 kGy Sterility Assurance Level (SAL): 100

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

#### Substantial Equivalency Comparison:

Like the Exactech MCS models (ref. #K921113 and #K990197), the proposed AcuMatch models are composed of titanium alloy (Ti-6Al-4V), have a trapezoidal crosssectional geometry, secondary distal tapers, optional calcar collars and optional hydroxyapatite (HA) coatings. The HA coating available on the AcuMatch models is identical to the one used for the predicate MCS component.

The differences in design features between the proposed AcuMatch and predicate MCS models include changes in the manufacturing technique, dimensional modifications to the neck region, a new sizing differential and changes to the surface presentations.

These design changes for the proposed AcuMatch models do not affect the intended use of the device and do not alter the fundamental scientific technology of the device.

In addition, the AcuMatch Press-Fit Stems have basic design features in common with femoral components designed by other orthopedic companies. These include but are not limited to Wright Medical's "Perfecta", Osteonic's "Secur-Fit HA", Sulzer's "APR Fully Textured" and Smith & Nephew's "Synergy" press-fit designs.

#### Performance Information:

Functional tests were conducted to verify that the performance of the AcuMatch Press-Fit stems would be adequate for anticipated in vivo loading. This performance data included fatigue testing of production quality parts, rotating beam fatigue tests of the wrought and forged materials, and vendor material certifications. The AcuMatch results exceeded those of the predicate MCS design which has a clinical history in excess of 7 years with no reported stem failures.

Based on the fatigue performance data, material specifications and design considerations, it is felt that the Exactech AcuMatch Press-Fit femoral components are substantially equivalent to the Exactech MCS femoral components (#K921113, #K990197).

> Section 4 Page 5 of 5

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Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and below the eagle are three wavy lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

# AUG 1 6 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K002141

Trade Name: AcuMatch P-Series Press-Fit, Plasma and HA Coated Femoral Components AcuMatch L-Series Press-Fit and HA Coated Femoral Components Regulatory Class: II Product Code: LWJ and MEH Dated: July 14, 2000 Received: July 17,2000

Dear Ms. Simpson:

We have reviewed your Section 510(k) 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2 - Ms. Lisa Simpson

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and IT you desire specific active for your actic devices), please contact the Office of Compliance at additionally 607.10 for in Thio diagnostions on the promotion and advertising of your device, [phone]. Additionally, for quest 21 (1) 594-4639. Also, please note the regulation prease connect the Office or Compilance en premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small miorination on Jour responsibility the number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

e R. lochner

M 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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### Indications for Use

510(k) Number:

1002141

Device Name:

AcuMatch P-Series Press-Fit Plasma AcuMatch P-Series Press-Fit AcuMatch L-Series Press-Fit

AcuMatch P-Series Press-Fit Plasma/HA AcuMatch P-Series Press-Fit/HA AcuMatch L-Series Press-Fit/HA

#### Intended Use / Indications:

AcuMatch Press-Fit Femoral Components are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, congenital hip dysplasia, 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 the AcuMatch Integrated Hip System.are.also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is present and to restore mobility resulting from previous fusion.

AcuMatch Press-Fitt Femoral Components are intended to be used in press fit applications. Components without the optional hydroxyapatite (HA) coating may also be used in cemented applications.

#### Contraindications:

AcuMatch Press-Fit Femoral Stem Components 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.

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

| | | | Concurrence of CDRH, Office of Device Evaluation (ODE) Vochines. |
|------------------|-----|----|------------------------------------------------------------------|
| | | | (Division Sign-Off) |
| | | | Division of General Restorative Devices |
| | | | 510(k) Number K002141 |
| Prescription Use | yes | or | Over the Counter Use No |

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