(85 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a bone cement spacer, with no mention of AI or ML technologies.
Yes.
The device is intended for use as a temporary shoulder replacement in patients undergoing a two-stage procedure due to a septic process, and it is composed of gentamicin/polymethylmethacrylate (PMMA) bone cement, which helps with the septic process by releasing antibiotics. Therefore, it has a therapeutic effect.
No
The device is a temporary shoulder replacement intended to treat a septic process, not to diagnose it.
No
The device description explicitly states it is composed of "fully formed gentamicin/polymethylmethacrylate (PMMA) bone cement," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Spacer-S is a temporary shoulder replacement for use in a surgical procedure (two-stage revision due to a septic process). This is a therapeutic device implanted directly into the body.
- Device Description: The description details the composition and form of an implantable prosthesis (gentamicin/PMMA bone cement mimicking a hemi-shoulder prosthesis).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. Spacer-S is an in vivo (inside the body) device used for surgical intervention and temporary support.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
HSD, KWS
Device Description
Spacer-S is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) bone cement. The one piece design mimics a hemi-shoulder prosthesis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
physician and/or surgeon
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Equinoxe Shoulder System device (#K042021)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
(a)
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.(b)
Classification. Class II.
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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
Temporary Shoulder Prosthesis |
|----------------------------------|---------------------------------------------------------------------------|
| Common name: | Shoulder spacer |
| Classification Name: | Prosthesis, Shoulder, Hemi-, Humeral,
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.
1
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
3
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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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 |
|---|---|
| ---------------------- | ---- |
- Number K060535