(79 days)
Not Found
No
The summary describes a mechanical knee implant system and its components. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on mechanical testing.
Yes.
The device is a knee replacement system intended to treat conditions like arthritis and fractures, directly addressing and improving a patient's health condition.
No
Explanation: The device is a knee replacement system, which is a prosthetic device used for treatment (surgical implantation), not for diagnosing medical conditions.
No
The device description clearly states it is comprised of physical components (Femur, Tibial Insert, Tibial Baseplate, and Patella) and describes their mechanical function, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant for replacing a joint in patients suffering from various conditions affecting the knee. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is described as a "tri-compartmental posterior stabilized knee for cemented applications," comprised of physical components like a Femur, Tibial Insert, Tibial Baseplate, and Patella. These are all physical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, or urine) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly an in vivo surgical implant.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
JWH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K905613, K923277, K932425, K933539, K020114, K932690, K932776, K933494, K933610, K011976, K030686
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 | Product
Code | Regulation and Classification Name |
|----------------------|-----------------|---------------------------------------------------------------------------------------------------------------------|
| Movation Knee System | JWH | Knee joint patellofemorotibial polymer/metal/polymer
semi-constrained cemented prosthesis per 21 CFR
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
System | 3DKnee System | OPTETRAK® Total
Knee System |
|------------------|---------------------------------------|----------------|------------------------------------------------------------|
| Manufacturer | Encore Medical | Encore Medical | Exactech |
| 510(k) Reference | K905613, K923277,
K932425, K933539 | K020114 | K932690, K932776,
K933494, K933610,
K011976, K030686 |
1
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.
2
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
3
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
4
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