SPACER-S TEMPORARY SHOULDER SPACER

K060535 · Tecres S.P.A. · HSD · May 24, 2006 · Orthopedic

Device Facts

• Record ID: K060535
• Device Name: SPACER-S TEMPORARY SHOULDER SPACER
• Applicant: Tecres S.P.A.
• Product Code: HSD · Orthopedic
• Decision Date: May 24, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Spacer-S is intended for use as a temporary (maximum 180 days) shoulder replacement in patients undergoing a two-stage procedure due to a septic process. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection) as defined by physician and/or surgeon.

Device Story

Spacer-S is a pre-formed, one-piece temporary shoulder prosthesis; composed of gentamicin-loaded polymethylmethacrylate (PMMA) bone cement. Designed for use in two-stage revision surgeries for septic shoulder conditions; provides structural support and local antibiotic delivery while systemic therapy is administered. Implanted by orthopedic surgeons in a clinical/hospital setting; intended for short-term use (maximum 180 days) before replacement with a permanent prosthesis. Device mimics hemi-shoulder anatomy; provides mechanical stability during the infection-clearing phase of treatment. Benefits include maintaining joint space and delivering localized antibiotics to the surgical site, potentially improving patient outcomes during complex revision procedures.

Clinical Evidence

Bench testing only. Evaluated fatigue strength, static strength, and antibiotic release kinetics to verify performance for temporary in vivo load applications. No clinical trial data presented.

Technological Characteristics

Material: Gentamicin-loaded polymethylmethacrylate (PMMA) bone cement. Form factor: One-piece pre-formed hemi-shoulder prosthesis. Energy source: None (passive implant). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for temporary use (max 180 days) as an adjunct to total or hemi-shoulder replacement in skeletally mature patients undergoing two-stage revision due to septic process.

Regulatory Classification

Identification

A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.

Predicate Devices

• Equinoxe Shoulder System (K042021)

Submission Summary (Full Text)

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K060535

MAY 2 4 2006

# Tecres Spacer-S

# Traditional 510(k)

# Summary of Safety and Effectiveness

May 24, 2006 Date:

Exactech® Inc. Applicant/Consultant: 2320 N.W. 66th Court Gainesville, Florida 32653 (352) - 377 - 1140 Phone: Fax: (352) - 378 - 2617 Contact: Gary J. Miller, PH.D. Exec. V.P. of R&D

Manufacturer: Tecres S.p.A FDA Owner/Operator ID# 9033624

#### Classifications / Proprietary Names:

| Trade / Proprietary Model Names: | Spacer-S<br>Temporary Shoulder Prosthesis |
|----------------------------------|---------------------------------------------------------------------------|
| Common name: | Shoulder spacer |
| Classification Name: | Prosthesis, Shoulder, Hemi-, Humeral,<br>Metallic, Cemented or Uncemented |
| Device Class: | II |
| Classification Panel: | Orthopedic |
| Product Code: | HSD |
| C.F.R. Section: | 888.3690 |

#### Device Description

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

#### Intended Use

Spacer-S is intended for use as a temporary (maximum 180 days) shoulder replacement in patients undergoing a two-stage procedure due to a septic process.

The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection) as defined by physician and/or surgeon.

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### Substantial Equivalence:

Based on a comparison of design features and the results of performance testing, it is concluded that the Spacer-S device is substantially equivalent functionally to the predicate Equinoxe Shoulder System device (#K042021). Whereas the Spacer-S device differs technologically from the predicate, the differences do not raise new questions of safety and effectiveness. In conclusion, the Spacer-S as a temporary shoulder prosthesis raises no new issues of safety and effectiveness considering the recommended duration of implantation for the Spacer-S.

### 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, and antibiotic release were evaluated and found to support the substantial equivalence of the device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a sans-serif font. The text is arranged around the top and left side of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 4 2006

Exactech, Inc. c/o Ms. Diana Taylor Manager, Regulatory Affairs 2320 NW 66th Court Gainesville, Florida 32653

Re: K060535

> Trade/Device Name: Tecres Spacer-S Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: Class II Product Code: HSD, KWS Dated: February 27, 2006 Received: February 28, 2006

Dear Ms. Taylor:

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

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## Page 2 - Ms. Diana Taylor

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 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/industry/support/index.html.

Sincerely vours.

Herbert Lemmons

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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Tecres-Spacer-S

# Traditional 510(k)

## Indications for Use

510(k) Number:

******************************************************************************************************************************************************************************

Device Name:

Tecres Spacer-S

## Indication for Use

Spacer-S is indicated for temporary use (maximum 180 days) as an adjunct to total shoulder replacement and hemi shoulder replacement procedures in skeletally mature patients undergoing a two-stage revision procedure due to a septic process. Spacer-S is only indicated for an implantation period of 180 days or less.

Please do not write below this line - use another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X |
|------------------|---|
|------------------|---|

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

| Over the Counter Use | No |
|----------------------|----|
|----------------------|----|

5100) Number K060535