The NovoKnee Total Knee System is Indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities.

The NovoKnee Total Knee System may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. The NovoKnee Total Knee System is designed for cemented use only.

Device Description

The present 510k submission is for a cruciate retaining (CR) version of the NovoKnee Total Knee System. The main predicate device (K123339) is a posterior stabilized (PS) version of the NovoKnee Total Knee System. All implant components are the same between the two versions, except for the tibial inserts and the femoral components. The posterior stabilized version has tibial inserts with posts and femoral components with cams that interact with the posts to help stabilize the knee after the posterior cruciate ligament is removed. The cruciate retaining version of the NovoKnee Total Knee System has tibial inserts and femoral components without posts or cams, allowing the posterior cruciate ligament to be "retained" and provide stability to the knee joint.

The NovoKnee Total Knee System is a Patellofemorotibia, polymer, semi-constrained, cemented knee prosthesis, that consists of a femoral component, tibial tray and patellar component. The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into the tibial baseplate component. Each femoral component has the same intercondylar distance and radius of curvature. Each tibial insert component is complimentarily shaped to conform to the femoral components. This allows any size fernoral component to be matched with any size tibial component. The dome shape of each UHMWPE patellar component provides excellent contact with the femoral component and evenly distributes stresses. The dome and sombrero shape of each UHMWPE patellar component provides contact with the femoral component.

AI/ML Overview

This document describes the validation of the NovoKnee Total Knee System, specifically the cruciate-retaining (CR) version, against its predicate device, a posterior-stabilized (PS) version of the same system. The study aims to demonstrate substantial equivalence, not to establish performance against specific acceptance criteria for effectiveness outcomes, but rather to show that new CR components perform comparably to previously cleared components in terms of mechanical integrity and design principles.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in a typical "threshold" format for clinical performance (e.g., sensitivity, specificity, accuracy). Instead, the acceptance criterion for the performance testing is demonstrating substantial equivalence to the predicate device in specific mechanical tests. The reported device performance is that this substantial equivalence was achieved.

Test Performed	Acceptance Criteria	Reported Device Performance
1. Femoral/Tibial Insert Contact Area Test	Substantial equivalence to predicate CR version	Test results indicate substantial equivalence to predicate. These components are the same as used in the predicate.
2. Anterior Shear Test of Insert/Tray Interlocking Mechanism	Substantial equivalence to predicate CR version	Test results indicate substantial equivalence to predicate.
3. Posterior Shear Test of Insert/Tray Interlocking Mechanism	Substantial equivalence to predicate CR version	Test results indicate substantial equivalence to predicate.
4. Medial/Lateral Shear Test of Insert/Tray Interlocking Mechanism	Substantial equivalence to predicate CR version	Test results indicate substantial equivalence to predicate.

Note: The text explicitly states, "All implant components are the same between the two versions, except for the tibial inserts and the femoral components." Furthermore, for the Femoral/Tibial Insert Contact Area Test, while not explicitly stated, contact area is a fundamental characteristic for knee implants, and the goal for the CR version is to demonstrate comparable contact mechanics to existing designs. The mention that "Each femoral component has the same intercondylar distance and radius of curvature. Each tibial insert component is complimentarily shaped to conform to the femoral components" implies a design intent to maintain similar contact characteristics. The overarching goal is substantial equivalence, which implies comparable performance in these tests to the predicate device.

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

The document does not specify a "test set" in the context of patient data. The performance testing described is mechanical (bench) testing of the device components. The sample size for these mechanical tests (e.g., number of implants or constructs tested) is not provided.

The data provenance is not applicable as this is a device modification submission based on mechanical testing and design comparison, not clinical trial data involving patients.

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

Not applicable. Ground truth for mechanical testing is established by engineering specifications and objective measurements, not expert consensus.

4. Adjudication Method for the Test Set

Not applicable, as this is mechanical testing, not a clinical study involving human assessment that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a 510(k) submission for a medical device modification (cruciate-retaining version of a total knee system), not an AI/software as a medical device (SaMD) or diagnostic imaging product that would typically involve an MRMC study comparing human readers with and without AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

No, this is not applicable. The device is a physical knee implant, not an algorithm.

7. Type of Ground Truth Used

For the mechanical performance tests, the "ground truth" implicitly used is the performance characteristics of the legally marketed predicate device (K123339, NovoKnee Total Knee System - PS version). The goal is to demonstrate that the novel CR version performs equivalently in these mechanical tests.

8. Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an algorithm or machine learning for this physical device.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for NovoSource. The logo is in black and white and features the word "NovoSource" in a bold, sans-serif font. To the right of the word "NovoSource" is a circle containing the letters "Ns". Below the word "NovoSource" is the text "K131398 (1/2)".

510(k) Summary

Applicant/Sponsor:

NovoSource, Inc. 714 East Monument Ave. Suite 220 Dayton, OH, 45402 937-531-6591

Contact Person:

David Letteri Vice President of Quality and Regulatory NovoSource, Inc. 714 East Monument Ave. Suite 220 Dayton, OH, 45402 937-531-6591

SEP 16 2013

DEVICE INFORMATION

Proposed Trade Name:	NovoKnee Total Knee System
Common Name:	Semi-constrained total knee prosthesis
Classification Name:	Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis per 21CFR 888.3560. This falls underthe Orthopedics panel/87 as a Class II device.
Device Product Code:	JWH
Predicate Device:	NovoKnee Total Knee System (K123339)United Orthopedic U2 Total Knee (K051640)

Device Description:

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tibial insert component is flat and "snaps" into the tibial baseplate component. Each femoral component has the same intercondylar distance and radius of curvature. Each tibial insert component is complimentarily shaped to conform to the femoral components. This allows any size fernoral component to be matched with any size tibial component. The dome shape of each UHMWPE patellar component provides excellent contact with the femoral component and evenly distributes stresses. The dome and sombrero shape of each UHMWPE patellar component provides contact with the femoral component.

Intended Use:

Total knee arthroplasty

Indications for Use:

The NovoKnee Total Knee System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. The NovoKnee Total Knee System may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. The NovoKnee Total Knee System is designed for cemented use only.

Summary of Technological Characteristics

The CR version of the NovoKnee Total Knee System has the same intended use and indications as the PS version of the NovoKnee Total Knee System. The CR version is manufactured from the same materials as the PS version. The range of sizes available for the CR version is the range of sizes of the PS version. The CR version design is substantially similar to the PS version system design. Based on these similarities, NovoSource believes that the CR version of the NovoKnee Total Knee System is substantially equivalent to the PS version of the NovoKnee Total Knee System.

Performance Testing

The following tests were performed in this submission:

1. Femoral/Tibial Insert Contact Area Test;
1. Anterior Shear Test of Insert/Tray Interlocking Mechanism;
1. Posterior Shear Test of Insert/Tray Interlocking Mechanism; and
1. Medial/Lateral Shear Test of Insert/Tray Interlocking Mechanism.

Test results indicate that the CR version of the NovoKnee Total Knee System is substantially equivalent to the PS version of the NovoKnee Total Knee System.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

September 16, 2013

NovoSource, Incorporated % Mr. James Pinkston IMDS Corporation 560 West Golf Course Road Providence, Utah 84332

Re: K131398

Trade/Device Name: NovoKnee Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knec joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: August 1, 2013 Received: August 2, 2013

Dear Mr. Pinkston:

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, labcling, 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 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 complics 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

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Page 2 - Mr. James Pinkston

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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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.

Sincercly yours.

Elizabeth L. Frank -S

for

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

K131398 510(k) Number (if known):

Device Name: NovoKnee Total Knee System

Indications for Use:

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of _1

Casey L. Hanley, Ph.D.

Division of Orthopedic Devices

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.