EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS

K040601 · Exactech, Inc. · KWZ · Oct 4, 2004 · Orthopedic

Device Facts

• Record ID: K040601
• Device Name: EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS
• Applicant: Exactech, Inc.
• Product Code: KWZ · Orthopedic
• Decision Date: Oct 4, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Exactech AcuMatch A-Series® and MCS® Constrained Acetabular Liners are components of the Exactech AcuMatch A-Series® or MCS® non-cemented acetabular cup system. The device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. They are intended for press-fit fixation and compatible with Exactech press-fit or cemented femoral stem components.

Device Story

Constrained acetabular liner system designed for hip arthroplasty; components of Exactech AcuMatch A-Series or MCS non-cemented acetabular cup systems. Device mechanically constrains 28mm or 32mm femoral heads using a titanium alloy constraining ring assembled to an acetabular shell. Used by orthopedic surgeons in clinical settings for patients at high risk of hip dislocation. Provides mechanical stability to the hip joint; reduces risk of recurrent dislocation in complex revision or primary cases. Compatible with Exactech press-fit or cemented femoral stems.

Clinical Evidence

Bench testing only. Evaluation included risk analysis and comparison to consensus standards per FDA Class II Special Controls Guidance Document for Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.

Technological Characteristics

Liners: compression molded UHMWPE (ASTM F648). Constraining rings: titanium alloy (Ti-6Al-4V, ASTM F136). Mechanical constraint of 28mm/32mm femoral heads via ring assembly to acetabular shell. Press-fit fixation.

Indications for Use

Indicated for primary or revision hip arthroplasty patients at high risk of dislocation due to prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability, where other constrained options have been considered.

Regulatory Classification

Identification

A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”

Predicate Devices

• Exactech AcuMatch (K993082)
• MCS (K921114)
• Ringloc Constrained Liner (K021728)
• Epsilon Durasul Constrained Acetabular Liner (K030923)

Submission Summary (Full Text)

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OCT 4 - 2004

# 510(k) Summary Pursuant to 21 CFR 807.92

| 1. | Submitted By: | Exactech, Inc.<br>2320 N.W. 66th Court<br>Gainesville, FL 32653 |
|----|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Contact: | Dr. Gary Miller<br>Executive Vice President of Research and<br>Development<br>Exactech, Inc.<br>2320 N.W. 66th Court<br>Gainesville, FL 32653<br>Phone: [phone]<br>Fax: [phone] |
| 3. | Product: | Exactech AcuMatch A-Series® & MCS®<br>Constrained Acetabular Liners<br>21 CFR Section 888.3310<br>Hip joint metal/polymer constrained<br>cemented or uncemented prosthesis<br>Class II<br>Product Code 87 KW7 |

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### Description:

Exactech AcuMatch A-Series® & MCS® Constrained Acetabular Liners are designed for use with appropriately sized Exactech AcuMatch A-Series and MCS® acetabular shells. The Constrained Liners are designed to mechanically constrain 28mm and 32mm femoral heads by use of a constraining ring. The constraining ring is mechanically assembled to a secure Exactech® acetabular shell.

### Intended Use:

Exactech AcuMatch A-Series® and MCS® constrained liners are components of the Exactech AcuMatch A-Series® or MCS® noncemented acetabular cup system. The device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. They are intended for press-fit fixation and compatible with Exactech press-fit or cemented femoral stem components.

#### Technological Characteristics and Substantial Equivalence:

The liners are machined from compression molded ultra-highmolecular-weight polyethylene (UHMWPE). Polyethylene raw material must meet all aspects of ASTM F648.

All rings are machined from titanium alloy (Ti-6A1-4V) conforming to ASTM F136.

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The devices are identical to previously cleared Exactech AcuMatch® (K993082) and MCS® (K921114) Lincrs except for the femoral head constraining features. The devices are similar to the Ringloc Constrained Liner (K021728) from Biomet Orthopedics and the Epsilon Durasul Constrained Acetabular Liner (K030923) from Centerpulse Orthopedics.

#### Performance Testing:

The Exactech AcuMatch A-Series® Constrained Acetabular Liner & MCS® Constrained Acetabular Liner have been evaluated according to FDA guidance document entitled: Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis; Guidance for Industry and FDA

The evaluation included a Risk Analysis and Comparison to Standards. Testing was done according to Consensus Standards.

Conclusions:

バ

The Exactech AcuMatch A-Series® & MCS® constrained Acetabular Liners are substantially equivalent to similar devices existing in the market in materials of construction, dimensions, and performance characteristics. It has been determined to be an effective design and when used according to instructions for use, is a useful and valuable device.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular in shape and features the department's emblem in the center. The emblem is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

OCT 4 - 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K040601

Trade/Device Name: Exactech AcuMatch A-Series® and MCS® Constrained Acetabular Liners Regulation Number: 21 CFR 888.3310 Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis Regulatory Class: II Product Code: KWZ Dated: June 30, 2004 Received: July 6, 2004

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 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

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Page 2 -- Ms. Lisa Simpson

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,

Ronald A. Williams, Ph.D., M.D.

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 Statement

| 510(k) Number: | K040601 |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Exactech AcuMatch A-Series® & MCS®<br>Constrained Acetabular Liners |
| Intended Use: | Exactech AcuMatch A-Series® and MCS®<br>Constrained Acetabular Liners are components of the<br>Exactech AcuMatch A-Series® or MCS® non-cemented<br>acetabular cup system. The device is intended for use in<br>primary or revision patients at high risk of hip dislocation<br>due to a history of prior dislocation, bone loss, soft tissue<br>laxity, neuromuscular disease, or intra-operative instability<br>and for whom all other options to constrained acetabular<br>components have been considered. They are intended for<br>press-fit fixation and compatible with Exactech press-fit or<br>cemented femoral stem components. |

X Prescription Use (Per CFR 801.109)

Of

Over-the-counter Use _________________________________________________________________________________________________________________________________________________________

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milherson
Division Sign-Off

(Division Sign-Off) (Division Dig.)
Division of General, Restorative, and Neurological Devices

104060 1 Page 510(k) Number_