MOTIVATION KNEE SYSTEM

K100900 · Encore Medical L.P. · JWH · Jun 18, 2010 · Orthopedic

Device Facts

• Record ID: K100900
• Device Name: MOTIVATION KNEE SYSTEM
• Applicant: Encore Medical L.P.
• Product Code: JWH · Orthopedic
• Decision Date: Jun 18, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Movation Knee System is a tri-compartmental posterior stabilized knee prosthesis for cemented total knee arthroplasty or revision. Components include femur, tibial insert, tibial baseplate, and patella. Design features total condylar geometry with post-and-cam mechanism to induce femoral rollback, provide resistance to tibial subluxation, and substitute for absent PCL. Used by orthopedic surgeons in clinical settings. Device restores joint function, improves stability, and allows clearance for deep flexion in patients with arthritis, necrosis, or deformities. Clinical benefit derived from mechanical replacement of damaged joint surfaces.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical functional bench testing in compliance with FDA guidance for knee joint prostheses, including constraint and fatigue testing to verify performance under anticipated in vivo loading.

Technological Characteristics

Tri-compartmental posterior stabilized knee system. Materials: UHMWPE (insert, patella) and CoCrMo (baseplate, femur). Design: total condylar with post-and-cam mechanism. Baseplate options: finned or trapezoid keel. Sterilization: gamma radiation (min 25 kGy) for SAL 10^-6. Cemented application.

Indications for Use

Indicated for patients with disability due to degenerative, post-traumatic, or rheumatoid arthritis; avascular necrosis of femoral condyle; post-traumatic loss of joint configuration (patellofemoral erosion, dysfunction, or prior patellectomy); moderate valgus, varus, or flexion deformities; or unmanageable fractures. Also indicated for salvage of failed surgical attempts. For cemented use.

Regulatory Classification

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).

Predicate Devices

• FOUNDATION® Knee System (K905613, K923277, K932425, K933539)
• 3DKnee System (K020114)
• OPTETRAK® Total Knee System (K932690, K932776, K933494, K933610, K011976, K030686)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] Email: [e-mail]

| Product | Product<br>Code | Regulation and Classification Name |
|----------------------|-----------------|---------------------------------------------------------------------------------------------------------------------|
| Movation Knee System | JWH | Knee joint patellofemorotibial polymer/metal/polymer<br>semi-constrained cemented prosthesis per 21 CFR<br>888.3560 |

## 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.

#### 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® Knee<br>System | 3DKnee System | OPTETRAK® Total<br>Knee System |
|------------------|---------------------------------------|----------------|------------------------------------------------------------|
| Manufacturer | Encore Medical | Encore Medical | Exactech |
| 510(k) Reference | K905613, K923277,<br>K932425, K933539 | K020114 | K932690, K932776,<br>K933494, K933610,<br>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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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 [phone] or [phone] 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