SPACER G TEMPORARY HIP PROSTHESIS

K031841 · Exactech, Inc. · KWL · Jan 22, 2004 · Orthopedic

Device Facts

• Record ID: K031841
• Device Name: SPACER G TEMPORARY HIP PROSTHESIS
• Applicant: Exactech, Inc.
• Product Code: KWL · Orthopedic
• Decision Date: Jan 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Spacer-G is indicated for temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) in patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). Spacer-G is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.).

Device Story

Spacer-G is a temporary hemi-hip prosthesis used as an adjunct to two-stage total hip replacement for septic processes. Device consists of AISI 316L stainless steel endoskeleton coated with gentamicin-loaded PMMA bone cement. Surgeon inserts device into femoral medullary canal and acetabular cavity after debridement and removal of infected implants. Device provides temporary structural support and local antibiotic delivery for up to 180 days; requires subsequent explantation and permanent replacement. Used in clinical/surgical settings by orthopedic surgeons. Benefits include maintaining joint space and managing infection via local antibiotic release during the interval between staged procedures.

Clinical Evidence

Bench testing only. Performance testing verified implant adequacy for in vivo load applications under temporary use conditions. Evaluated fatigue strength, static strength, wear characteristics, and antibiotic release rate.

Technological Characteristics

Hemi-hip prosthesis; AISI 316L stainless steel endoskeleton; gentamicin-loaded PMMA bone cement coating; one-piece design; sterile (SAL 10^-6).

Indications for Use

Indicated for patients undergoing two-stage total hip replacement (THR) due to septic process. Contraindicated in patients with: decreased immune response; inadequate bone structure; muscular/nervous/vascular deficiencies; osteoporosis; unconfirmed THR infection; non-removable infected implants; gentamicin-resistant pathogens; sensitivity to gentamicin, aminoglycosides, or PMMA; systemic/remote infection; non-THR related infection; insufficient bone stock; neuromuscular disorders; or weight/age/activity levels predicting early 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

• Osteo Austin Moore Endoprosthesis (K974807)

Submission Summary (Full Text)

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JAN 2 2, 2004

2320 NW 661H COU GAINESVILLE, FL 326

## Tecres Spacer-G

Traditional 510(k)

K031841/352-3//1140
FAX [phone]/
page 1 of 3

# Summary of Safety and Effectiveness

| Applicant/ Consultant: | Exactech® Inc.<br>2320 N.W. 66th Court<br>Gainesville, Florida 32653 | | |
|-------------------------|----------------------------------------------------------------------|--------------------------------------------|--|
| | Phone:<br>Fax: | (352) - 377 - 1140<br>(352) - 378 - 2617 | |
| | Contact: | Gary J. Miller, PH.D.<br>Exec. V.P. of R&D | |
| Manufacturer/Submitter: | Tecres S.p.A<br>FDA Owner/Operator ID# 9033624 | | |

Date:

October 24, 2003

rev. 10/24/03

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Ko3184/ page 245

## Tecres Spacer-G

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

#### Classifications / Proprietary Names:

| Classification Name: | Hip joint, femoral (hemi-hip), metallic,<br>cemented or uncemented |
|----------------------------------|--------------------------------------------------------------------|
| Product Code: | KWY |
| C.F.R. Section: | 888.3390 |
| Device Class: | II |
| Classification Panel: | Orthopedic |
| Trade / Proprietary Model Names: | Spacer-G<br>Temporary Hip Prosthesis |

## Legally Marketed Device for Substantial Equivalence Comparison:

The Spacer-G device is substantially cquivalent to the "Osteo Austin Moore Endoprosthesis" (Osteonics Corporation). The "Osteo" device was cleared for marketing through premarket submission #K974807.

| Model | Manufacturer | 510(k) Number |
|--------------------|--------------|---------------|
| Osteo Austin Moore | Osteonics | #K974807 |

#### Device Description:

The Spacer-G is a "hemi-hip" style device. The one-picce design incorporates a load bearing endoskeleton of AISI 316L stainless steel and an outer coating of fully formed gentamicin/polymethylmethacrylate (PMMA) bone cement. The implants are supplied stcrile to an assurance level (SAL) of 10-6.

Spacer-G is indicated for temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) in patients undergoing a two-stage procedure due to a septic process.

The device is inserted into the femoral medullary canal and acctabular cavity following removal of the existing femoral and acetabular implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

Spacer-G is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.).

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## Tecres Spacer-G

K05184/ page
273

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

#### CONTRAINDICATIONS

Use of Spacer-G is contraindicated in the following situations:

- The patient's condition is such that a two-stage arthroplasty procedure is contraindicated due to decreased immune response or other relevant systemic clinical conditions.
- Lack of adequate bone structure precludes adequate support of the prosthesis in the proximal femur or acetabular region.
- The procedure is unjustified due to deficiencies in the patient's muscular, nervous or vascular systems.
- Poor bone quality (as in osteoporosis) could cause the prosthesis to migrate or to fracture host bone.
- Infection of the THR cannot be confirmed. -
- The infected THR devices cannot be removed. -
- The infecting pathogens are resistant to gentamicin. -
- The patient is sensitive (allergic) to gentamicin, aminoglycosides or PMMA bone ・ cement.
- A systemic or sccondary remote infection is suspected or confirmed. -
- The patient does not have a THR and the infection is secondary to trauma, septic arthritis or other surgical procedures.
- The patient does not have sufficient bone stock to allow insertion and fixation of the prosthesis
- The patient has neuromuscular disorders that do not allow control of the hip joint. -
- The patient's weight, age or activity level would cause the surgeon to expect early failure of the system.

#### PERFORMANCE DATA

Performance testing was conducted to verify that the implant performance would be adequate for anticipated in vivo load applications under the temporary conditions of use. The fatigue strength, static strength, wear characteristics and antibiotic release rate were evaluated and found to support the safety and effectiveness of the device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 2 2004

Gary J. Miller, Ph.D. Executive Vice President Research and Development Exactech. Inc. 2320 NW 66" Court Gainesville, Florida 32653

Re: K031841 Trade/Device Name: Tecres Spacer-G Regulation Number: 21 CFR 888.3360, 21 CFR 888.3390 Regulation Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis, Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis Regulatory Class: II Product Code: KWL, KWY Dated: October 24, 2003 Received: October 27, 2003

Dear Dr. Miller:

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 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

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Page 2 - Gary J. Miller, Ph.D.

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.

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 11 Jou utball 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/cdrlv/dsma/dsmamain.html

Sincerely vours,

Mark N. Milliman

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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#### Tecres Spacer-G Indications for Use

**510(k) Number:**

K03184/

Tecres Spacer-G Device Name:

Spacer-G is indicated for temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) in patients undergoing a two-stage procedure due to a septic process.

The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The device is intended for use or the banking temore antimicrobial antibiotic therapy (standard treatment approach to an infection).

Spacer-G is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.).

#### CONTRAINDICATIONS

Use of Spacer-G is contraindicated in the following situations:

- The patient's condition is such that a two-stage arthroplasty procedure is contraindicated due to decreased immune response or other relevant systemic clinical conditions.
- Lack of adequate bone structure precludes adequate support of the prosthesis in the proximal femur or acetabular region.
- The procedure is unjustified due to deficiencies in the patient's muscular, nervous or vascular systems.
- Poor bone quality (as in osteoporosis) could cause the prosthesis to migrate or to fracture host bone.
- Infection of the THR cannot be confirmed. -
- The infected THR devices cannot be removed. -
- The infecting pathogens are resistant to gentamicin. -
- The patient is sensitive (allergic) to gentamicin, aminoglycosides or PMMA bone cement.
- A systemic or secondary remote infection is suspected or confirmed. -
- The patient docs not have a THR and the infection is secondary to trauma, septic arthritis or other surgical procedures.
- The patient does not have sufficient bone stock to allow insertion and fixation of the prosthesis
- The patient has neuromuscular disorders that do not allow control of the hip joint.
- The patient's 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)

Prescription Use

3 us

or

Over the Counter Use