degenerative, post-traumatic or rheumatoid arthritis; .
avascular necrosis of the femoral condyle; .
post-traumatic loss of joint configuration, particularly when there is patellofemoral . erosion, dysfunction or prior patellectomy;
moderate valgus, varus or flexion deformities; .
treatment of fractures that are unmanageable using other techniques. .

This device may also be indicated in the salvage of previously failed surgical attempts. This system is intended to be used for cemented applications.

Device Description

The Movation Knee System is a tri-compartmental posterior stabilized knee for cemented applications. The system is comprised of four primary components: Femur, Tibial Insert, Tibial Baseplate, and Patella. The system is intended to treat patients who are candidates for primary total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. The design of the knee system is a total condylar design, increasing sagittal conformity and stability. The post and cam of the posterior stabilized design are crucial to inducing femoral rollback and providing resistance to tibial subluxation, substituting the function of the absent PCL. The tibial post in combination with the femoral cam is designed to encourage femoral roll-back on the tibia and allow clearance for deep flexion.

AI/ML Overview

The Movation Knee System is a medical device and therefore the acceptance criteria are not based on performance metrics like accuracy, sensitivity, or specificity, but rather on regulatory compliance and substantial equivalence to predicate devices. The study proving the device meets acceptance criteria is a non-clinical study involving functional testing, rather than a clinical study with human subjects.

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

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Implicit)	Reported Device Performance
Functional Equivalence: Implant performance for anticipated in vivo loading via various constraint and fatigue tests.	Functional testing was conducted in compliance with FDA guidance ("Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses: Guidance for Industry and FDA") to verify that the implant performance would be substantially equivalent to predicate devices. (Specific performance metrics are not provided, only the statement that equivalence was verified).
Design/Material Equivalence: Components (Femur, Tibial Baseplate, Tibial Insert, Patella) are comparable in design and materials to predicate devices.	Femur: Asymmetric anterior flange (similar to Optetrak), total condylar design with post and cam articulating geometry (similar to Optetrak), anatomic component (similar to Foundation PS Knee). Baseplate: Asymmetric perimeter, finned or trapezoid keel (similar to Foundation and Optetrak, respectively). Posterior Stabilized Insert: Symmetric component (similar to Foundation PS and Optetrak PS Systems). Patella: Domed geometry with three pegs (similar to Optetrak), same diameters as Optetrak and Foundation (MTS). Materials: UHMWPE for Insert and Patella; CoCrMo for Baseplate and Femur (all similar to predicate devices).
Packaging and Sterilization Equivalence: Method of packaging and sterilization is comparable to predicate devices.	Packaged and sterilized using the same method as the 3DKnee System. Sterilization by gamma radiation (minimum 25 kGy) to achieve a Sterility Assurance Level (SAL) of 10^-6.
Regulatory Compliance & Substantial Equivalence: Adherence to FDA regulations and demonstration of substantial equivalence to legally marketed predicate devices.	The FDA reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. (This is the ultimate acceptance criteria for a 510(k) submission).

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

Test Set Sample Size: Not applicable in the context of this 510(k) submission. The "test set" here refers to the physical device components undergoing non-clinical bench testing. The document doesn't specify the number of individual implants or components subjected to each functional test.
Data Provenance: The data provenance is from non-clinical functional testing conducted by the manufacturer, Encore Medical, L.P. The location of the testing is not specified, but it's internal company testing for regulatory submission. It is not retrospective or prospective clinical data.

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

Not applicable. For a medical device 510(k) submission, the "ground truth" for non-clinical testing is typically defined by industry standards, engineering specifications, and FDA guidance documents. There is no mention of external human experts establishing ground truth for the functional tests themselves. The FDA reviewers (Division of Surgical, Orthopedic, and Restorative Devices) are the experts who evaluate the submission against regulatory requirements.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image review by multiple human readers. For non-clinical bench testing, the results are objectively measured against pre-defined engineering criteria, and therefore, an adjudication method for disagreements among human reviewers is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical Testing: None provided."

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

Not applicable. The Movation Knee System is a physical medical device (an orthopedic implant), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" was established by:

FDA Guidance: "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses: Guidance for Industry and FDA."
Industry Standards: Implicitly, as functional testing is conducted to verify performance against "anticipated in vivo loading." While not explicitly named, these would refer to relevant ISO or ASTM standards for implant testing.
Predicate Device Performance: Performance that demonstrates "substantial equivalence" to the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable, as there is no training set for this device.

Summary

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JUN 1 8 2010

Summary of Safety and Effectiveness

Date:

June 17, 2010

Manufacturer: Encore Medical, L.P. (d.b.a. DJO Surgical) 9800 Metric Blvd Austin, TX 78758

Contact Person: Elizabeth Onderlinde Regulatory Affairs Specialist Phone: (512) 834-6302 Fax: (512) 834-6313 Email: beth.onderlinde@djosurgical.com

Product	ProductCode	Regulation and Classification Name
Movation Knee System	JWH	Knee joint patellofemorotibial polymer/metal/polymersemi-constrained cemented prosthesis per 21 CFR888.3560

Description:

Indications for Use:

Joint replacement is indicated for patients suffering from disability due to:

degenerative, post-traumatic or rheumatoid arthritis; .
avascular necrosis of the femoral condyle: .
post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, . dysfunction or prior patellectomy:
moderate valgus, varus or flexion deformities; .
treatment of fractures that are unmanageable using other techniques. .

This device may also be indicated in the salvage of previously failed surgical attempts. This system is to be used for cemented applications

Predicate Devices:

Device Name	FOUNDATION® KneeSystem	3DKnee System	OPTETRAK® TotalKnee System
Manufacturer	Encore Medical	Encore Medical	Exactech
510(k) Reference	K905613, K923277,K932425, K933539	K020114	K932690, K932776,K933494, K933610,K011976, K030686

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Comparable Features to Predicate Device:

The Movation and Optetrak femurs exhibit an asymmetric anterior flange. The Movation knee is characterized as a total condylar knee, with kinematics guided by post and cam articulating geometry, also similar to the Optetrak Knee. The Movation femur is an anatomic component similar to the Foundation PS Knee.

The Baseplate exhibits an asymmetric perimeter, similar to the Foundation Knee, with options for a finned keel or trapezoid keel. The shape of the finned keel is similar to the Foundation knee, while the shape of the trapezoid keel is similar to the Optetrak knee.

The Posterior Stabilized Insert is a symmetric component and is similar to the Foundation PS and Optetrak PS Systems.

The Patella features a domed geometry with three pegs similar to the Optetrak Patella. The diameters are the same as Optetrak and Foundation (MTS).

The Insert and Patella are manufactured from UHMWPE, while the Baseplate and Femur are manufactured from CoCrMo. All of these materials are similar to those materials used for the Foundation, 3DKnee and Optetrak systems.

The Movation Knee System is packaged and sterilized using the same method as the 3DKnee System. Sterilization of implants is by gamma radiation at the minimum dose of 25 kGy to achieve a Sterility Assurance Level (SAL) of 10-6.

Non-Clinical Testing:

Functional testing was conducted in compliance with FDA guidance, Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses: Guidance for Industry and FDA. to verify that the implant performance would be substantially equivalent to predicate devices for anticipated in vivo loading via various constraint and fatigue tests.

Clinical Testing:

None provided.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

JUN 1 8 2010

Encore Medical, L.P. % Ms. Elizabeth Onderlinde Regulatory Affairs Specialist 9800 Metric Boulevard Austin, Texas 78758

Re: K100900

Trade/Device Name: Movation Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prothesis Regulatory Class: II Product Code: JWH Dated: March 26, 2010 Received: March 31, 2010

Dear Ms. Onderlinde:

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.

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

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Page 2 - Ms. Elizabeth Onderlinde

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.

Barbara Bueno

ark 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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510(k) Number (if known):

Device Name: Movation Knee System

Indications for Use:

Joint replacement is indicated for patients suffering from disability due to:

degenerative, post-traumatic or rheumatoid arthritis; .
avascular necrosis of the femoral condyle; .
post-traumatic loss of joint configuration, particularly when there is patellofemoral . erosion, dysfunction or prior patellectomy;
moderate valgus, varus or flexion deformities; .
treatment of fractures that are unmanageable using other techniques. .

This device may also be indicated in the salvage of previously failed surgical attempts. This system is intended to be used for cemented applications.

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)

Sonetta for myn
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100900

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.