SPACER-G TEMPORARY HIP PROSTHESIS

K062273 · Tecres S.P.A. · KWL · May 22, 2008 · Orthopedic

Device Facts

• Record ID: K062273
• Device Name: SPACER-G TEMPORARY HIP PROSTHESIS
• Applicant: Tecres S.P.A.
• Product Code: KWL · Orthopedic
• Decision Date: May 22, 2008
• 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 a total hip replacement (THR) in skeletally mature 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 radical 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 pre-formed, one-piece temporary hip prosthesis composed of gentamicin-loaded polymethylmethacrylate (PMMA) bone cement. It is designed for use in two-stage revision surgeries to treat hip joint infections. During the first stage, surgeons remove existing implants and perform radical debridement; the Spacer-G is then inserted into the femoral medullary canal and acetabular cavity to maintain joint space and provide local antibiotic delivery. The device is intended for temporary implantation (maximum 180 days) while the patient undergoes systemic antibiotic therapy. After the infection is cleared, the spacer is explanted and replaced with a permanent hip prosthesis. The device benefits patients by maintaining joint function and providing localized antimicrobial support during the interval between infection treatment and definitive reconstruction.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and performance characteristics.

Technological Characteristics

One-piece hemi-hip prosthesis composed of gentamicin-loaded polymethylmethacrylate (PMMA) bone cement. Designed for temporary insertion into the femoral medullary canal and acetabular cavity.

Indications for Use

Indicated for skeletally mature patients undergoing two-stage total hip replacement due to septic process. Temporary use only (max 180 days). Requires concurrent systemic antibiotic therapy.

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

• Spacer-G (K031841)
• Biomet Stage One Disposable Cement Spacer Mold for Temporary Hip Prosthesis with Reinforcement Stem (K052990)
• Biomet Cobalt G HV Bone Cement (K051532)

Submission Summary (Full Text)

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## Spacer-G Modification

## 510 (k) Summary

MAY 2 2 2008

510(k) Summary

Applicant/consultant:

Manufacturer/Submitter:

EXACTECH. INC. 2320 N.W. 66TH COURT GANESVILLE, FLORIDA 32653 PHONE: (352) - 377 - 1140 FAX: (352) - 378 - 2617 CONTACT: Mike Simpson

TECRES S.P.A. VIA ANDREA DORIA 37066 SOMMACAMPAGNA VERONA — ITALY

FDA OWNER/OPERATOR ID #: 9033624

Date:

May 21, 2008

Trade/Proprietary model names: SPACER-G TEMPORARY HIP PROSTHESIS

II

Common name:

TEMPORARY HEMI-HIP PROSTHESIS; TEMPORARY HIP SPACER WITH GENTAMICIN

PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Regulation number: 888.3360

Device class:

Device classification name:

Classification panel: ORTHOPAEDIC

Classification Product Code : KWL: KWY

DEVICE DESCRIPTION

Spacer-G is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) bone cement. The one piece design mimics a hemi-hip prosthesis.

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## Spacer-G Modification 510(k) Summary Continued

#### INDICATIONS FOR USE:

Spacer-G is indicated for temporary use (maximum 180 days) as a total hip replacement (THR) in skeletally mature 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 radical debridement. The device is intended for use in conjunction with systemic 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.).

### SUBSTANTIAL EQUIVALENCE:

The modified Spacer-G device has the same design, incorporates the same materials, has equivalent performance and mechanical characteristics, and has the same shelf and packaging as the predicate Spacer-G device (K031841). Additionally, the modified Spacer-G device has a similar gentamicin release profile as that of the predicate Biomet Stage One Disposable Cement Spacer Mold for Temporary Hip Prosthesis with Reinforcement Stem (K052990) when used with predicate Biomet Cobalt G HV Bone Cement (K051532).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure. The symbol is composed of several curved lines that create the shape of the bird's body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 2 2008

Exactech, Inc. % Mr. Xavier Sarabia Director, Regulatory Affairs 2320 N.W. 66th Court Gainesville, Florida 32653

Re: K062273

Trade/Device Name: Spacer-G Regulation Number: 21 CFR 888.3360 Regulation Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWL, KWY Dated: February 22, 2008 Received: February 25, 2008

Dear Mr. Sarabia:

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 conceming 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 - Mr. Xavier Sarabia

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.

IIf you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

---

Mark N. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Spacer-G Modification

# Indications for Use

510(k) Number (if known): _K062273

Device Name: Spacer-G

Indications for Use:

Spacer-G is indicated for temporary use (maximum 180 days) as a total hip replacement (THR) in skeletally mature 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 radical 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.).

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use No (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neilke Sle for BK
(Division Sign-Off)

Page _ of _/

Division of General, Restorative, and Neurological Devices

**510(k) Number** K062273

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