Osteoarthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis .
Failed osteotomies
Avascular necrosis of femoral condyle .
Post traumatic loss of joint configuration
Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability
Primary implantation failure if there is sufficient bone .

The device is intended for cemented use only.

Device Description

The GKS Prime Flex CR Total Knee System is a tricompartmental fixed bearing total knee prosthesis comprised of femoral, patellar, and tibial components with ultra-high molecular weight polyethylene articular inserts. The femoral components are offered in left and right versions in eight sizes each. The tibial baseplate components are offered in seven sizes offered in two styles: Universal which will work with either left or right knees and Anatomic which provides components anatomically shaped for left and right knees. The keel has a cylindrical body with two stabilizing wings and allows for future use of extension stems. The tibial inserts fit into the tibial baseplates by a snap-in mechanism. The cruciate retaining tibial inserts are offered in seven sizes, each size in four thicknesses from 10 mm to 18 mm. These tibial inserts work with the universal design or either the left or right anatomic version. The patella is offered in four sizes from 32 to 38 mm. The devices are for cemented use only.

The bone opposing surfaces are not coated but have their surfaces roughened by sand blasting.

The tibial baseplates come with threaded plugs for bone screw holes as no bone screws are available with this system. A distal plug for a future extension stem is also provided.

The GKS Prime Flex CR Total Knee System femoral components are made of Cobalt Chromium Molybdenum (CoCrMo) according to ISO 5832-4. Tibial baseplate components, threaded plugs for screw holes, and distal plug are made of titanium alloy (Ti6-Al4-V) according to ISO 5832-3. Tibial inserts and patellar components are made of standard ultra-high molecular weight polyethylene (UHMWPE) according to ISO 5834-1/2.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria	Reported Device Performance
Material Testing	Materials must conform to relevant ISO standards: - Femoral components: Cobalt Chromium Molybdenum (CoCrMo) according to ISO 5832-4. - Tibial baseplate components, threaded plugs, distal plug: Titanium alloy (Ti6-Al4-V) according to ISO 5832-3. - Tibial inserts and patellar comp: UHMWPE according to ISO 5834-1/2.	The GKS Prime Flex CR Total Knee System components are made of the specified materials, conforming to the respective ISO standards.
Functional Testing (Nonclinical)	Acceptance criteria were pre-defined and based on applicable standards and FDA guidance documents (specifically: "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial Metal/Polymer Porous Coated Uncemented Prostheses: Guidance for Industry and FDA"). This included:	"The testing met all acceptance criteria and verifies that performance of the GKS Prime Flex CR Total Knee System is substantially equivalent to the predicate devices." (Detailed results for each test are not provided.)
- Fatigue testing of the tibial base plate	(Specific quantitative criteria not explicitly detailed in the summary, but implied by adherence to guidance and overall acceptance.)	Conducted; criteria met.
- Constraint and contact pressure of patella-femoral and femoro-tibial interfaces	(Specific quantitative criteria not explicitly detailed.)	Conducted; criteria met.
- Modular connections of tibial inserts to tibial baseplates	(Specific quantitative criteria not explicitly detailed.)	Conducted; criteria met.
Overall Performance (Substantial Equivalence)	The device must demonstrate substantial equivalence to predicate devices with respect to indications for use and technological characteristics.	"The data and information provided in this submission support the conclusion that the GKS Prime Flex CR Total Knee System is substantially equivalent to its predicate devices with respect to indications for use and technological characteristics."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document states that testing was conducted on "the worst case component size and option/design." No specific numerical sample size (e.g., number of units tested, number of cycles for fatigue) is provided.
Data Provenance: The testing was nonclinical (laboratory-based performance testing). The document does not specify a country of origin for the data beyond Permedica SpA being an Italian manufacturer, but indicates the testing was conducted in accordance with FDA guidance documents. It is retrospective in the sense that the testing was performed and then summarized for the submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable as the study described is a nonclinical, performance-based study on a medical device (knee replacement system), not a study involving human interpretation or diagnosis where "ground truth" would be established by experts.

4. Adjudication Method for the Test Set

This information is not applicable as the study is a nonclinical, performance-based study, not one requiring adjudication of human assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical data and conclusions are not needed for this device." The study was nonclinical performance testing.

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

This information is not applicable. The device is a physical medical implant (a total knee system), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm does not apply. The performance testing described is inherently "standalone" in the sense that it's the device itself being tested in a controlled, non-human environment.

7. The type of ground truth used

The "ground truth" for this nonclinical performance study was established by pre-defined acceptance criteria based on applicable standards and guidance documents (e.g., ISO standards, FDA guidance for knee prostheses). This includes expectations for material properties and specific functional performance metrics (fatigue, constraint, contact pressure, modular connection integrity).

8. The sample size for the training set

This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI models. The device's design is developed through engineering and manufacturing processes, not trained on data.

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

This information is not applicable for the same reason as point 8.

Summary

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510(k) Summary

DEC 2 0 2012

Manufacturer:

permedica SpA Via Como, 38 23807 Merate (Lc) - ITALY +39 039 9514811 . phone: fax: www.permedica.com info@permedica.com

Contact-Person:

Ms. Natalie J. Kennel Consultant NJK & Associates, Inc. 13721 Via Tres Vista San Diego, CA 92129 USA Phone: (858) 705-0350 Fax: (858) 764-9739 email: NKennel@njkconsulting.com

September 25, 2012 Date Prepared:

DEVICE INFORMATION

G.K.S. Prime Flex CR Total Knee System Trade/Proprietary Name: Total Knee Prosthesis Common Name: Knee joint, patellofemorotibial metal/polymer/metal Classification Name: Semi-constrained cemented prosthesis, 21 CFR 888.3560

Main Predicate: NexGen® Complete Knee Solution

K023211 NexGen® Complete Knee Solution Cruciate Retaining (CR) - Flex (Zimmer)

K072281 NexGen® Prolong™ All Poly Patella (Zimmer)

K933785 NexGen® Complete Knee Solution (Zimmer)

Other Predicates

K081023 Evolis Total Knee System (Medacta International)

K041825 Genesis II Deep Flexion Cruciate Retaining Articular Insert (Smith and Nephew)

K110950 Consensus Knee System, Consensus Orthopedics (based on K932837)

K971189 P.F.C Sigma Knee System (Johnson & Johnson Professional, Inc., now DePuy Orthopedics)

GKS Prime Flex CR 510(k)

Section 5 - Page 1 of 3

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Product Description:

The GKS Prime Flex CR Total Knee System is a tricompartmental fixed bearing total knee prosthesis comprised of femoral, patellar, and tibial components with ultra-high molecular weight polyethylene articular inserts. The femoral components are offered in left and right versions in eight sizes each. The tibial baseplate components are offered in seven sizes offered in two styles: Universal which will work with either left or right knees and Anatomic which provides components anatomically shaped for left and right knees. The keel has a cylindrical body with two stabilizing wings and allows for future use of extension stems.1 The tibial inserts fit into the tibial baseplates by a snap-in mechanism. The cruciate retaining tibial inserts are offered in seven sizes, each size in four thicknesses from 10 mm to 18 mm. These tibial inserts work with the universal design or either the left or right anatomic version. The patella is offered in four sizes from 32 to 38 mm. The devices are for cemented use only.

The bone opposing surfaces are not coated but have their surfaces roughened by sand blasting.

The tibial baseplates come with threaded plugs for bone screw holes as no bone screws are available with this system. A distal plug for a future extension stem is also provided.

Indications for Use:

G.K.S. PRIME FLEX CR is indicated for use in patients with severely painful and disabled joints due to:

Osteoarthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis .
. Failed osteotomies
Avascular necrosis of femoral condyle .
Post traumatic loss of joint configuration ●
Moderate varus, valgus or flexion deformity in which the ligamentous . structures can be returned to adequate function and stability
Primary implantation failure if there is sufficient bone .

The device is intended for cemented use only.

GKS Prime Flex CR 510(k)

Section 5 - Page 2 of 3

1 Extension stems are not part of this submission

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Comparison to Predicate Devices

The GKS Prime Flex CR Total Knee System has the same intended use as all of the predicate devices. It has very similar indications for use as its main predicate, the NexGen® Complete Knee Solution. The GKS Prime Flex CR Total Knee System components are made of the same materials for each component as one or more of the predicate devices. The GKS Prime Flex CR Total Knee System components' design and technological characteristics are similar to one or more of the predicate devices.

Performance Testing (Nonclinical and/or clinical)

No performance standards applicable to this device have been adopted under Section 514 of the Food, Drug and Cosmetic Act. Nonclinical performance testing of the GKS Prime Flex CR Total Knee System was conducted in accordance with the applicable standards and FDA guidance documents, specifically Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial Metal/Polymer Porous Coated Uncemented Prostheses: Guidance for Industry and FDA..

The GKS Prime Flex CR Total Knee System was tested as part of design verification to written protocols with pre-defined acceptance criteria. The protocols and pre-defined acceptance criteria were based on the applicable standards and guidance. The testing was conducted on the worst case component size and option/design. Functional testing, according to the above cited FDA guidance, included fatigue testing of the tibial base plate, constraint and contact pressure of the patella-femoral and femoro-tibial interfaces, and modular connections of tibial inserts to tibial baseplates. The results of the GKS Prime Flex CR testing were compared to published results of similar testing of predicate devices. The testing met all acceptance criteria and verifies that performance of the GKS Prime Flex CR Total Knee System is substantially equivalent to the predicate devices.

Clinical data and conclusions are not needed for this device.

Conclusion:

The data and information provided in this submission support the conclusion that the GKS Prime Flex CR Total Knee System is substantially equivalent to its predicate devices with respect to indications for use and technological characteristics.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

December 20, 2012

Permedica, S.p.A. % NJK & Associates Ms. Natalie J. Kennel RA Consultant 13721 Via Tres Vista San Diego, California 92129

Re: K122975

Trade/Device Name: GKS Prime Flex CR Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Codes: JWH Dated: September 25, 2012 Received: September 26, 2012

Dear Ms. Kennel:

We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are substantially equivalent (for the indications for use stated in the enclosures) 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 devices, 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.

If your devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices 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 devices comply with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 – Ms. Natalie J. Kennel

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.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm l 15809.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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Peter D. Rumm -S

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

Enclosure

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Indications for Use Statement

510(k) Number (if known): K122975

Device Name: GKS Prime Flex CR Total Knee System

Indications for Use:

G.K.S. PRIME FLEX CR is indicated for use in patients with severely painful and disabled joints due to:

Osteoarthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis .
Failed osteotomies �
Avascular necrosis of femoral condyle .
Post traumatic loss of joint configuration ●
Moderate varus, valgus or flexion deformity in which the ligamentous ● structures can be returned to adequate function and stability
Primary implantation failure if there is sufficient bone .

The device is intended for cemented use only.

Prescription Use × Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR (Part 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey Hanley

For Division of Orthopaedic Devices

Page 1 of 1

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.