MODIFICATION TO EXACTECH ACUMATCH INTEGRATED HIP SYSTEM, M-SERIES HIGH OFF-SET NECK SEGMENT, M-SERIES LOW OFF-SET NECK S

K010120 · Exactech, Inc. · LPH · Feb 9, 2001 · Orthopedic

Device Facts

• Record ID: K010120
• Device Name: MODIFICATION TO EXACTECH ACUMATCH INTEGRATED HIP SYSTEM, M-SERIES HIGH OFF-SET NECK SEGMENT, M-SERIES LOW OFF-SET NECK S
• Applicant: Exactech, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Feb 9, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

AcuMatch M-Series 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 M-Series are also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is present and to restore mobility resulting from previous fusion. The AcuMatch M-Series components are indicated for press-fit and cemented applications.

Device Story

AcuMatch M-Series is a modular femoral stem system for total hip arthroplasty; comprises proximal neck, metaphyseal, and diaphyseal segments secured with a locking screw. Components are titanium alloy. High and low off-set neck segments provide anatomical sizing options. Used in OR by orthopedic surgeons for press-fit or cemented fixation. Device restores hip joint function and mobility in patients with degenerative disease or fractures. Surgeon selects appropriate neck offset based on patient anatomy; modularity allows intraoperative customization. Benefits include improved fit and stability compared to standard components.

Clinical Evidence

Bench testing only. Finite Element Analysis was performed to compare the performance of the proposed high and low off-set neck segments against the predicate M-Series neck design under anticipated in-vivo loading conditions. Results confirmed that the proposed devices exhibit adequate performance characteristics comparable to the predicate.

Technological Characteristics

Modular femoral stem system; titanium alloy construction. Components include proximal neck, metaphyseal, and diaphyseal segments with locking screw. Design features high and low off-set neck variants. Intended for press-fit or cemented application. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients undergoing primary total hip replacement for osteoarthritis, osteonecrosis, congenital hip dysplasia, rheumatoid arthritis, ankylosing spondylitis, post-traumatic degenerative hip problems, or proximal femoral fractures. Also indicated for revision of failed previous reconstructions with sufficient bone stock. Contraindicated in patients with active infection, insufficient bone stock for fixation, neuromuscular disorders preventing hip 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

• M-Series (K993736)
• S-Rom (Joint Medical Products)
• Impact (Biomet)
• Mallory Head (Biomet)
• Link (Link America)

Submission Summary (Full Text)

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lo120

2320 NW 66TH COUR1 GAINESVILLE, FL 3265.

352-377-1140 FAX [phone]

# FEB - 9 2001

Exactech® AcuMatch™ Integrated Hip System M-Series Femoral Stem Component High & Low Off-Set Neck Segments

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

Sponsor:

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

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

FDA Establishment Number 1038671

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

Date:

January 10, 2001

Section 4 Page 1 of 4

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# Exactech® AcuMatch™ Integrated Hip System M-Series Femoral Stem Component High & Low Off-Set Neck Segments

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

| Trade Name: | Exactech® AcuMatch M-Series<br>High Off-Set Neck<br>Low Off-Set Neck |
|-----------------------|--------------------------------------------------------------------------------------------|
| Common Name: | Total Hip Prosthesis Femoral Component |
| Classification Name: | Prothesis, Hip, Semi-Constrained, Metal/Polymer,<br>Porous, Uncemented (Femoral Component) |
| Product Code: | LPH |
| Device Class: | II |
| Classification Panel: | Orthopedic |

#### Legally Marketed Devices for Substantial Equivalence Comparison:

| Model | Manufacturer | 510(k) |
|--------------|---------------------------|----------|
| M-Series | Exactech Inc. | #K993736 |
| S-Rom | Joint Medical<br>Products | |
| Impact | Biomet | |
| Mallory Head | Biomet | |
| Link | Link America | |

The AcuMatch M-Series high and low off-set neck segments are made of similar materials and are of a similar design to other legally marketed modular femoral components. Most notably, the proposed neck segments are equivalent in materials and design to the Exactech's predicate M-Series neck segments. M-Series components are also similar to the "S-ROM" by Joint Medical Products Corporation, the Biomet "Impact", and "Mallory-Head" and the "Link MP" by Link America.

### Section 4 Page 2 of 4

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# Exactech® AcuMatch™ Integrated Hip System M-Series Femoral Stem Component High & Low Off-Set Neck Segments

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

#### Description:

The Exactech Modular Stem is a four-piece system consisting of a proximal neck segment, metaphyseal segment, diaphyseal segment and a locking screw. All of the components are interchangeable, therefore allowing for many sizing combinations to meet varying anatomical situations. The components are composed of titanium alloy. Design changes were made to the original neck segments cleared through premarket notification #K993736:

- A. High Offset Neck Segments
- Material was added to the lateral radius of all neck segments. 1.
- 2. A new "-5 Neck Segment" model was added.

#### B. Low Offset Neck Segments

A new "Low Offset" Neck version of neck is proposed. These models represent a reduction in horizontal offset of 5mm as compared to the predicate design (#K993736):

- Low Offset -- 5 Neck Segment 1.
- Low Offset Standard (+0) Neck Segment 2.
- 3. Low Offset +10 Neck Segment

#### Intended Use:

AcuMatch M-Series 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 M-Series are also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is present and to restore mobility resulting from previous fusion.

The AcuMatch M-Series components are indicated for press-fit and cemented applications.

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# Exactech® AcuMatch™ Integrated Hip System M-Series Femoral Stem Component High & Low Off-Set Neck Segments

# 510(k) Summary of Safety and Effectiveness

### Contraindications:

AcuMatch M-Series components are contraindicated in patients with active infection, Aculviation M-36Ttes components are to allow appropriate insertion and fixation of the patients without surficient bolle stock of the mot allow control of the hip joint, and in prosulchis, in nedromascural enetivity level would cause the surgeon to expect early failure of the system.

### Performance Data Summary:

Finite Element Analysis was conducted to verify that the performance of the proposed I high and low off-set neck segments would be adequate for anticipated in-vivo loading. The results showed that the proposed devices have performance characteristics I he results blowed than Exactech's predicate M-Series neck design.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, bold line drawing.

FEB = 9 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K010120

Trade Name: Exactech® Integrated Hip System

AcuMatch™ M-series Femoral Stem Component High and Low Offset Neck Segments Regulatory Class: II Product Code: LPH Dated: January 10, 2001

Received: January 16, 2001

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 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 (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 additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mark N Mulkerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Exactech® AcuMatch™ Integrated Hip System M-Series Femoral Stem Component

#### Indications for Use

510(k) Number:

K0/0/20

Device Name:

Exactech Integrated Hip System AcuMatch M-Series Femoral Stem Component High Off-Set Neck Segment Low Off-Set Neck Segment

#### Indications for use:

AcuMatch M-Series Femoral Components are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, osteonecrosis, congenital hip dysplasia, rheumatoid arthritis, ankylosing spondylitis, and/or post-traumatic degenerative problems. M-Series components are also potentially indicated for revision of failed previous reconstructions where sufficient bone stock is present.

AcuMatch M-Series components are intended to be used in press-fit and cemented applications.

#### Contraindications:

AcuMatch M-Series 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.

Mark N Melkerson

Division Sign-Off) Division of General, R rative and Neurological Devi

< 010120

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510(k) Number

time - use another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

12

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Over the Counter Use

Counter Use No

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