Hip Modular Spacer: The Hip Modular Spacer, which consists of a modular head and stem, is indicated for temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organisms. The head and stem components are inserted into the acetabular cavity and femoral medullary canal, respectively, following removal of the existing acetabular and femoral components and radical debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection). The Hip Modular Spacer 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.).

Knee Modular Spacer: The Knee Modular Spacer, which consists of a modular femoral, tibial insert component, is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in patients undergoing a two-stage procedure due to a septic process and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organism(s). The device is applied on the femoral condyles (femoral component) and on the tibial plate (tibial component) following removal of the existing implant and radical debridement. The use of the tibial insert component is optional, when a large tibial defect is present. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The Knee Modular Spacer 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.). Because of the inherent mechanical limitations of the device materials (gentamicin/polymethylmethacrylate), the device is only indicated for patients who will consistently use traditional mobility assist devices (e.g., crutches, walkers, canes) throughout the implantation period.

Device Description

The Modular Spacers are sterile, single-use devices intended for temporary use (maximum 180 days) as joint replacements. The Hip Modular Spacer is composed of two components (a head and a stem) that are intended to be used together to form a temporary hip spacer; the components are available in a range of sizes. The Knee Modular Spacer is composed of three independent components (a femoral component, a tibial component and a tibial insert component) that are intended to be used together to form a temporary knee spacer; the components are available in a range of sizes. The devices are made of fully formed polymethylmethacrylate (PMMA), which is radioopaque, and contains gentamicin and color additives to give a green color. The Modular Spacers provide a functional-mechanical mode of action; they provide patients a temporary implant allowing for a natural range of motion and partial weight-bearing during treatment. They are designed to preserve soft tissue to prevent further complications, such as muscular contraction, and to facilitate the subsequent joint replacement procedure.

AI/ML Overview

The provided text describes a medical device, the Garventis Modular Spacer (Hip and Knee), and its premarket notification (510(k)) to the FDA. The submission focuses on demonstrating substantial equivalence to predicate devices through various tests rather than a clinical study evaluating diagnostic performance. Therefore, many of the requested categories related to clinical study design, human readers, and expert ground truth are not applicable.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines several types of tests performed to demonstrate the device's safety and effectiveness compared to predicate devices. The acceptance criteria are generally implied to be meeting the standards of the referenced ISO and ASTM guidelines.

Acceptance Criteria Category	Reported Device Performance
Material Properties:
Biocompatibility	Met acceptance criteria per ISO 10993, demonstrating materials are safe, suitable, and appropriate for intended use.
Mechanical Performance:
Static testing (resin)	Met acceptance criteria (ISO 5833).
Fatigue testing (resin)	Met acceptance criteria (ASTM F2118).
Fatigue testing (device spacer)	Met acceptance criteria (ISO 7206-4, ISO 7206-6, ASTM F1800, ISO 14243-1).
Surface roughness testing (spacer device)	Met acceptance criteria (ISO 4287-97).
Head size comparison (femoral head)	Met acceptance criteria (ISO 7206-9).
Disassembly test (femoral head)	Met acceptance criteria (ISO 7206-9).
Pharmacological Performance:
Antibiotic elution testing	Data presented to demonstrate performance. Specific quantitative acceptance criteria or results are not detailed in this summary.
Bacterial anti-adhesivity testing	Data presented to demonstrate performance. Specific quantitative acceptance criteria or results are not detailed in this summary.
Sterility & Shelf Life:
Sterility	Data presented to show sterility.
Packaging integrity	Data presented to show suitability and integrity of packaging.
Shelf life	Data presented to support proposed shelf life.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not applicable. The studies conducted are primarily non-clinical performance tests on the device itself (materials, mechanical properties, drug elution) rather than clinical studies on patient data.
Data Provenance: Not applicable for device performance testing. These are laboratory-based tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth for these types of engineering and materials tests is established by adhering to recognized international standards (ISO, ASTM) and measuring physical, chemical, and mechanical properties.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is not a diagnostic device requiring expert adjudication of results.

5. 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 is not an AI/imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical performance tests, the "ground truth" is based on established engineering and material science standards (e.g., ISO 10993 for biocompatibility, ISO 5833 for static testing, ASTM F2118 for fatigue testing). The device performance is compared against the requirements and specifications defined by these standards.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

GENERAL INFORMATION 1

1.1 Submitter and Owner of the 510(k)

Garventis LLC

Ronald Reagan and International Trade Center 1300 Pennsylvania Ave., NW - Suite 700 Washington, D.C. 20004

Official Correspondent 1.2

Diane Mandell Horwitz, Ph.D., RAC Regulatory Affairs Consultant Mandell Horwitz Consultants, LLC 2995 Steven Martin Drive Fairfax. Virginia 20031

Telephone: (703) 307-2921 Fax: (703) 242-1117 E-mail: dmh(@mandellhorwitzconsulting.com

Date of Preparation 1.3

March 29, 2012

NAME OF THE DEVICE 2

Trade/Proprietary Name 2.1

Hip Modular Spacer Knee Modular Spacer

Common/Usual Name 2.2

Modular temporary hip prosthesis with gentamicin Modular temporary knee prosthesis with gentamicin Bone cement, antibiotic

2.3 Classification Information

Classification Name:

Hip Joint Femoral (hemi-hip) Metallic Cemented or Uncemented Knee Joint Patellofemorotibial Polymer/Metal/Polymer Polymethylmethacrylate (PMMA) bone cement

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Classification Regulation:21 CFR & 888.3360 21 CFR & 888,3560 21 CFR & 888.3027

Regulatory Class: Class II

Product Code:

KWL, KWY JWH MBB

Panel:

Orthopedic

3 PREDICATE DEVICES

The predicate devices are the Tecres Interspace Hip and Knee devices cleared in 510(k) submissions K101356. The predicate devices are temporary spacers that have been classified under 21 CFR § 888.3360 and 888.3560, and are Class II medical devices.

4 DESCRIPTION OF THE DEVICE

The Modular Spacers are sterile, single-use devices intended for temporary use (maximum 180 days) as ioint replacements. The Hip Modular Spacer is composed of two components (a head and a stem) that are intended to be used together to form a temporary hip spacer; the components are available in a range of sizes. The Knee Modular Spacer is composed of three independent components (a femoral component, a tibial component and a tibial insert component) that are intended to be used together to form a temporary knee spacer; the components are available in a range of sizes.

The devices are made of fully formed polymethylmethacrylate (PMMA), which is radioopaque, and contains gentamicin and color additives to give a green color.

The Modular Spacers provide a functional-mechanical mode of action; they provide patients a temporary implant allowing for a natural range of motion and partial weight-bearing during treatment. They are designed to preserve soft tissue to prevent further complications, such as muscular contraction, and to facilitate the subsequent joint replacement procedure.

INDICATIONS FOR USE AND INTENDED USE ട്

The Modular Spacers have the following indications for use statements.

Hip Modular Spacer

The Hip Modular Spacer, which consists of a modular head and stem, is indicated for temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin is the most uppropriate antibiotic based on the susceptibility pattern of the infecting micro-organisms.

The head and stem components are inserted into the acetubular cavity and femoral medullary canal, respectively, following removal of the existing acetabular and femoral components and radical debridement.

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The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection).

The Hip Modular Spacer is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implunted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.).

Knee Modular Spacer

The Knee Modular Spacer, which consists of a modular femoral, tibial insert component, is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in patients undergoing a two-stage procedure due to a septic process and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organism(s).

The device is applied on the femoral component) and on the tibial plate (tibial component) following removal of the existing implant and radical debridement. The use of the tibial insert component is optional. when a large tibial defect is present. The device is intended for use in conjunction with systemic antimicrobial untibiotic therapy (standard treatment approach 10 an infection).

The Knee Modular Spacer 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.). Because, of the inherent mechanical limitations of the device materials (gentamicin(polymethylmethacrylate), the device is only indicated for patients who will consistently use traditional mobility assist devices (e.g., crutches, walkers, canes) throughout the implantation period.

This is the same intended use as the predicate devices. The Garventis Modular Spacers and the Tecres Interspace Hip and Knee devices are intended to be used in the same surgical procedure (two-stage revision procedure) in the same target patient population, and provide the same primary function of providing patients a temporary implant to allow for a natural range of motion and partial weight bearing.

TECHNOLOGICAL CHARACTERISTICS AND PERFORMANCE DATA 6

The Garventis Modular Spacer devices share many similar technological characteristics compared to the predicate Tecres Interspace Hip and Knee devices. The Garventis Modular Spacers and the predicate Tecres Interspace Hip and Knee share a similar size, shape and geometry, and are made from the same materials (PMMA). Each hip device also contains an inner stainless steel core for support. The Garventis Modular Spacers and the predicate Tecres Interspace Hip and Knee both incorporate gentamicin. Both devices share the same tissue contact and duration of contact. Both are provided preformed to the user, sterile, for single-use.

The design of the Hip Modular Spacer differs from the predicate device by its modular nature; it is provided as separate head and stem components, which have to be combined to achieve the final configuration of the implant. The design of the Knee Modular Spacer differs from the predicate device by its modular nature; it is provided as separate femoral and tibial components that must be coupled to achieve the final configuration of the implant. A tibial Insert is also available to be combined optionally with the Tibial component for increasing the final thickness.

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The performance data presented in this 510(k) application demonstrate the substantial equivalence of the Garventis Modular Spacers to the predicate devices, and to establish that the devices are as safe and effective as the predicates.

Biocompatibility studies were conducted according to ISO 10993 to demonstrate that the device materials are safe, suitable and appropriate for their intended use.

Physical, mechanical and pharmacological testing met the acceptance criteria to demonstrate the safety and effectiveness of the Garventis Modular Spacers. Static testing (ISO 5833) and fatigue testing (ASTM F2118) were conducted of the resin; fatigue testing (ISO 7206-4, ISO 7206-6, ASTM F1800, ISO 14243-1); surface roughness testing (1SO 4287-97) of the spacer device; head size comparison and disassembly test (ISO 7206-9) of the femoral head; antibiotic elution testing and bacterial anti-adhesivity testing.

Data were presented to show the sterility of the device, the suitability and integrity of the packaging, and to support the proposed shelf life.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird.

Public Health Service

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

APR - 5 2012

Garventis, LLC. % Mandell Horwitz Consultants, LLC Diane M. Horwitz, Ph.D., RAC 2995 Steven Martin Drive Fairfax, Virginia 22031

Re: K112470

Trade/Device Name: 2GC Hip Modular Spacer 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, and MBB

Trade/Device Name: 2GC Knee Modular Spacer Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II

Product Code: JWH and MBB

Dated: March 15, 2012 Received: March 16, 2012

Dear Dr. Horwitz:

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 - Diane M. Horwitz, Ph.D., RAC

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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.fda.gov/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/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,
E. Keith

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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1-02. Indications for Use Statement

510(k) Number:

K12470

Device Names:

Hip Modular Spacer .

INDICATIONS FOR USE STATEMENTS

The Hip Modular Spacer, which consists of a modular head and stem, is indicated for temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organisms.

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

The Hip Modular Spacer 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.).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

and/or

Prescription Use X (Part 21 CFR 801 Subpart D) Over the Counter Use (21 CFR 801 Subpart C)

Signature

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112470

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1-02. Indications for Use Statement

510(k) Number:

K112470

Device Names:

Knee Modular Spacer

INDICATIONS FOR USE STATEMENT

The Knee Modular Spacer, which consists of a modular femoral, tibial insert component, is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in patients undergoing a for telliporary ase (maxmuli 100 ae)s and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organism(s).

The device is applied on the femoral condyles (femoral component) and on the tibial plate (tibial component) following removal of the existing implant and radical debridement. The use of the tibial insert component is optional, when a large tibial defect is present. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

The Knee Modular Spacer is not intended for use for more than 180 days, at which time it must be explanted THE Knev Modular Dpacer is not mension of en appropriate treatment performed (e.g. resection arthroplasty, mechanical limitations of the device materials Because of the inherent fusion etc.). (gentamicin/polymethylmethacrylate), the device is only indicated for patients who will consistently use (Echiamontopor)invalyment (e.g., crutches, walkers, canes) throughout the implantation period.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

and/or

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

Klaus D. Bohn

(Division Sign-Off) (Division Sign-Sign-Sical, Orthopedic, Division of Restorative Devices

510(k) Number K112470

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.