← Product Code [HSD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSD) · K112983

# SPACER-S (K112983)

_Tecres S.P.A. · HSD · Dec 12, 2011 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSD/K112983

## Device Facts

- **Applicant:** Tecres S.P.A.
- **Product Code:** [HSD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSD.md)
- **Decision Date:** Dec 12, 2011
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3690
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## Intended Use

Interspace Shoulder is indicated for temporary use (maximum of 180 days) as a shoulder replacement (SR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The head and stem are inserted into the glenoideal cavity and the humeral medullary canal, respectively, following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection). Interspace Shoulder 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

Temporary shoulder prosthesis; composed of PMMA bone cement impregnated with gentamicin; includes internal stainless steel metal core for reinforcement. Mimics hemi-shoulder prosthesis design. Used in two-stage revision procedures following removal of infected implant and radical debridement. Inserted into glenoideal cavity and humeral medullary canal by orthopedic surgeons. Provides structural support and local antibiotic delivery during infection treatment period. Must be explanted within 180 days and replaced with permanent implant or alternative treatment. Benefits include maintaining joint space and delivering local antibiotics while systemic therapy addresses infection.

## Clinical Evidence

Bench testing only. No clinical data presented. Performance testing verified mechanical properties, gentamicin release, and stability to support substantial equivalence.

## Technological Characteristics

PMMA bone cement with gentamicin; internal stainless steel metal core. Semi-constrained hemi-shoulder prosthesis design. Temporary implant. Sterilization method not specified.

## Regulatory 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

- Interspace Shoulder Spacer ([K060535](/device/K060535.md))

## Submission Summary (Full Text)

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510(k) Summary

Christine L. Brauer, Ph.D. Official correspondent: US AGENT Manufacturer/Submitter: Tecres S.p.A. Via A. Doria 6 37066 Sommacampagna Verona - Italy FDA Owner/Operator ID: 9033624 December 9, 2011 Date: 510(k) Number: K112983 Trade/Proprietary model names: Interspace Shoulder Temporary Shoulder Prosthesis with Gentamicin Common name: Semi-constrained Cemented Prosthesis Prosthesis, Shoulder, Device classification name: Hemi-, Humeral, Metallic, Cemented or Uncemented 21 CFR § 888.3690 Classification regulation Class II Regulatory class: Orthopedic Classification panel: HSD - Prosthesis, Shoulder, Hemi-, Humeral, Metallic Classification product code: Uncemented Semi-Constrained, Shoulder. Prosthesis, K WS — Metal/Polymer, Cemented The Interspace Shoulder devices is a temporary device Device description: composed of fully formed PMMA bone cement with gentamicin and an inner stainless steel metal core. The design mimics a hemi-shoulder prosthesis. Indication for Use and IntendedInterspace Shoulder is indicated for temporary use (maximum of 180 days) as a shoulder replacement (SR) in skeletally Use: mature patients undergoing a two-stage procedure due to a septic process. The head and stem are inserted into the glenoideal cavity and the humeral medullary canal, respectively, following removal of the existing implant and radical debridement. The device is

... ..........................................................................................................................................................................

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DEC 1 2 2011

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| Substantial Equivalence: | intended for use in conjunction with systemic antimicrobia<br>antibiotic therapy (standard treatment approach to an<br>infection).<br>Interspace Shoulder is not intended for use for more than 180<br>days, at which time it must be explanted and a permanent<br>device implanted or another appropriate treatment performed<br>(e.g. resection arthroplasty, fusion etc.). |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|                          | The Interspace Shoulder Spacer has the same intended use as<br>the predicate device, the Interspace Shoulder Spacer cleared<br>via K060535. Both devices are intended for use as a<br>temporary shoulder implant for patients undergoing a two-<br>stage revision procedure due to an infection.                                                                              |
|                          | The Tecres Interspace Shoulder Spacer device is substantially<br>equivalent to itself. The device has previously been cleared:<br>K060535. The intended use and conditions of use remain the<br>same. This 510(k) application was submitted for the<br>introduction of a metal reinforcing structure into the device<br>and to add a new material supplier.                   |
|                          | Performance testing was conducted to verify that implant<br>performance continues to meet the productions specifications<br>and be adequate for in vivo application under the temporary<br>conditions of use. Mechanical properties, gentamicin release<br>and stability data were evaluated and found to support the<br>substantially equivalence of the devices.            |
|                          | Based on the same fundamental scientific technology and on<br>the results of the verification activities, it is concluded that the<br>modified Tecres Interspace Shoulder Spacer device is<br>substantially equivalent to legally marketed Tecres spacer<br>device.                                                                                                           |

:

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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 features the department's emblem, which is a stylized caduceus-like symbol with three lines representing the human form. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged in a circular fashion around the emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DEC 1 2 2011

Tecres S.p.A. % Brauer Device Consultants, LLC Christine L. Brauer. Ph.D. Regulatory Affairs Consultant 7 Trailhouse Court Rockville, Maryland 20850

Re: K112983

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: November 18, 2011 Received: November 18, 2011

Dear Dr. Brauer:

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. Ilsting 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 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.

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Page 2 - Christine L. Brauer, Ph.D.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fdagov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melk Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K112983

Device Names: Interspace Shoulder

## INDICATIONS FOR USE STATEMENT

## Interspace Shoulder

Interspace Shoulder is indicated for temporary use (maximum of 180 days) as a shoulder replacement (SR) in skeletally mature patients undergoing a two-stage procedure due to a septic process.

The head and stem are inserted into the glenoideal cavity and the humeral medullary canal, respectively, following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection). Interspace Shoulder 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.).

Signature of

(Division Sign-Off) (Division Sign-On), Orthopedic, Divisionative Devices

510(k) Number *_*_

Please do not write below this line - use another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Part 21 CFR 801 Subpart D) and/or Over the Counter Use (21 CFR 801 Subpart C)

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSD/K112983](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSD/K112983)

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