Spacer-K is indicated for temporary use (maximum of 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process.

Spacer-K is applied on the femoral condyles and on the tibial plate following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

Spacer-K is not intended for use for more than 180 days, at which time it must be explanted and permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). Because of the inherent mechanical limitations of the device material (gentamicin/polymethylmethacrylate), Spacer-K is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.

Spacer-G is indicated for temporary use (maximum of 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 implant 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 Description

Spacers are temporary joint prostheses. Spacer-G is a single piece device that mimics a hemi-hip prosthesis, and is available in six sizes. Spacer-K includes a femoral and tibial component, and is available in three sizes. Spacer-G and Spacer-K are made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin). Spacer-G contains an inner stainless steel (AISI 316L stainless steel) reinforcing structure. The mass used in the filling of the molds (the PMMA unformed resin) is prepared from a powder component and a liquid component. The liquid component consists of methylmethacrylate, N,N-dimethyl-p-toluidine, hydroquinone; the powder component consists of polymethymethacrylate, barium sulphate, benzovl peroxide, and gentamicin sulphate.

The Spacer devices provide patients, undergoing a two-stage revision procedure for an infected total joint, a temporary implant to 1) allow for partial weight bearing and 2) provide a natural range of motion. The devices also maintain a patient's soft tissue and joint space, preventing further complications such as muscular contraction. The gentamicin protects the device from bacterial colonization.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Tecres Spacer-G and Spacer-K, based on the provided documents:

Acceptance Criteria and Device Performance

The provided 510(k) summary (K101356) does not explicitly state specific quantitative acceptance criteria or detailed performance data in a table format. Instead, it relies on substantiating that the modified devices (Spacer-G and Spacer-K) are substantially equivalent to their previously cleared versions (K062274 for Spacer-K and K062273 for Spacer-G).

The core acceptance criterion implicitly stated is:

The modified Spacer devices must perform equivalently to their previously cleared versions, ensuring continued safety and effectiveness for their intended temporary use.

The reported device performance is described as:

"Performance testing was conducted to verify that implant performance continues to meet the production specifications and be adequate for in vivo applications under the temporary conditions of use."
"Mechanical properties, gentamicin release and stability data were evaluated and found to support the substantial equivalence of the devices."

Without quantitative metrics provided in these documents, a table cannot be fully populated. However, we can infer the categories of assessment:

Acceptance Criteria Category	Reported Device Performance (Qualitative)
Mechanical Properties	Evaluated and found to support substantial equivalence to previously cleared devices.
Gentamicin Release	Evaluated and found to support substantial equivalence to previously cleared devices (for antibacterial function).
Stability	Evaluated and found to support substantial equivalence to previously cleared devices.
Production Specifications	Implant performance continues to meet production specifications.
In Vivo Adequacy	Adequate for in vivo applications under temporary conditions of use.

Study Information

The 510(k) summary for K101356 describes an evaluation for "substantial equivalence" rather than a de novo clinical study with patients. The study primarily involves performance testing to compare a modified device (minor material change) to an established, previously cleared device.

Sample size used for the test set and the data provenance:
- The document does not specify the sample size for any test set in terms of clinical data or patient cohorts. The performance testing appears to be conducted on the devices themselves (e.g., in vitro mechanical testing, elution studies).
- Data provenance: Not explicitly stated as retrospective or prospective clinical data. Given the nature of a 510(k) for a minor material change to a previously cleared device, the testing would likely be bench testing and possibly some in vitro or ex vivo studies. No specific country of origin for clinical data is mentioned as such data doesn't appear to be the primary basis for this particular submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this 510(k) submission. The evaluation is based on engineering and material science performance testing, not on interpretation of patient data by medical experts. "Ground truth" here refers to established material properties and performance benchmarks.
Adjudication method for the test set:
- Not applicable as there is no mention of a human expert review or adjudication process for a test set of clinical cases. The evaluation is against engineering specifications and pre-established performance of the predicate device.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a temporary orthopedic implant, not an AI-powered diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical device.
The type of ground truth used:
- Engineering specifications and performance characteristics of the previously cleared predicate devices (K062274 and K062273). The "ground truth" for the modified device's performance is that it matches or exceeds the established performance of its predecessors, as demonstrated through mechanical, gentamicin release, and stability testing.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning study, so there is no concept of a "training set."
How the ground truth for the training set was established:
- Not applicable.

Summary

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February 28, 2023

TECRES S.p.A Christine Brauer Regulatory Affairs Consultant 7 Trail House Court Rockville, Maryland 20850

Re: K101356

Trade/Device Name: Spacer-G and Spacer-K 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, MBB, JWH

Dear Christine Brauer:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated September 20, 2011. Specifically, FDA is updating this SE Letter with regards to the trade name, and product codes as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Limin Sun, Ph.D., OHT6: Office of Orthopedic Devices at 301-796-7056 or Limin.Sun(@fda.hhs.gov.

Sincerely,

Limin Sun -S

Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

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

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

TECRES SPA % Christine Brauer, Ph.D. Brauer Device Consultants. LLC 7 Trailhouse Court Rockville, Maryland 20850

SEP 2 0 2011

Re: K101356 Trade/Device Name: Tecres Spacer-G Regulation Number: 21 CFR 888.3360 Regulation Name: Prosthesis, hip, hemi-, femoral, metal Regulatory Class: Class II Product Code: KWL, KWY, and MBB

Trade/Device Name: Tecres Spacer-K Regulation Number: 21 CFR 888.3560 Regulation Name: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer Regulatory Class: Class II Product Code: JWH and MBB

Dated: July 27, 2010 Received: July 28, 2010

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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Page 2 - Christine Brauer, Ph.D.

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.

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 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 clectronic 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.fda.gov/Aboutf-DA/CentersOffices/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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark A. Mulkerin

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

Enclosure

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ATTACHMENT 2

Indications for Use Form

510(k) Number (if known):

K101356

Device Name:

Spacer-K and Spacer-G

Indications for Use:

Spacer-K

Spacer-K is indicated for temporary use (maximum of 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process.

Interspace is applied on the femoral condyles and on the tibial plate 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).

Spacer-K is not intended for use 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.). Because of the inherent mechanical limitations of the device material (gentamicin/polymethylmethacrylate), Spacer K is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.

Spacer-G

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

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

ivision of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101356

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

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SEP 2 0 2011

୍ଦ

510(k) Summary
510(k) Summary:	K101356
Official correspondent:	CHRISTINE L. BRAUER, PH.D.US AGENT
Manufacturer/Submitter:	TECRES S.P.A.VIA A. DORIA 637066 SOMMACAMPAGNAVERONA - ITALYFDA OWNER/OPERATOR ID #: 9033624
Date:	SEPTEMBER 14, 2011
Trade/Proprietary model names:	SPACER-G AND SPACER-KTEMPORARY HIP AND KNEE PROSTHESIS
Common name:	TEMPORARY HIP AND KNEE SPACER WITH GENTAMICIN
Device classification name:	PROSTHESIS, HIP, HEMI-, FEMORAL, METALPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Regulation number:	888.3360 AND 888.3560
Device class:	II
Classification panel:	ORTHOPAEDIC
Classification Product Code:	KWL, KWY, AND JWH

510 (k) Summary

: : :

Tecres

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DEVICE DESCRIPTION:

INTENDED USE AND INDICATIONS FOR USE:

Spacer-G and Spacer-K are indicated for temporary use (maximum 180 days) as a total hip or knee replacement for patients undergoing a two-stage procedure due to a septic process. The indications for use are provided below.

Spacer-K

Spacer-K is indicated for temporary use (maximum of 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic Drocess.

Spacer-G

Spacer-G is indicated for temporary use (maximum of 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 implant and radical debridement. The device is intended for use in

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conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

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कर

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SUBSTANTIAL EQUIVALENCE:

The Spacer devices are substantially equivalent to themselves. Each Spacer device has previously been cleared: Spacer-K in K062274 and, Spacer-G in K062273. The intended use and conditions of use remain the same. This 510(k) application was submitted for a minor change in the materials in each Spacer device.

Performance testing was conducted to verify that implant performance continues to meet the production specifications and be adequate for in vivo applications under the temporary conditions of use. Mechanical properties, gentamicin release and stability data were evaluated and found to support the substantial equivalence of the devices.

Based on the same fundamental scientific technology and on the results of the verification activities, it is concluded that the modified Tecres Spacer devices are substantially equivalent to the legally marketed Tecres Spacer devices.

Regulation Number and Section

§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

(a)
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.(b)
Classification. Class II.