(64 days)
Not Found
No
The summary describes a knee implant component made of specific materials and dimensions, with performance studies focused on mechanical and material properties. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for joint replacement due to various degenerative and post-traumatic conditions, and for the salvage of failed surgical attempts, which are all therapeutic interventions aimed at treating a medical condition or improving a patient's health.
No
Explanation: The provided text describes a joint replacement system (Movation Knee System) used for treating various degenerative conditions of the knee. Its intended use is for surgical intervention (joint replacement), not for diagnosing conditions. The device description and performance studies focus on the materials and mechanical properties of the implant.
No
The device description clearly states it is a physical implant (tibial insert) made of UHMWPE, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided information clearly describes a knee implant system used for joint replacement surgery. It is a physical device implanted into the body to replace damaged joint components.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze biological samples or provide diagnostic information. Its purpose is to restore joint function through surgical implantation.
The information provided describes a surgical implant, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Movation Knee System is Indicated For:
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, OIY
Device Description
The Movation Highly Cross Linked Vitamin E Tibial Inserts are manufactured from HXL VE (75KgY) ultra high molecular weight polyethylene (UHMWPE). The tibial inserts are available in 11 sizes (1,2,3,4,5,6,7,8,10,12, and 14) and 6 thicknesses (9mm -21mm) and are provided neutral in orientation. The tibial insert is identical in design to the compression molded UHMWPE Movation tibial insert cleared via K100900. The tibial insert is identical in materials to the Highly Cross-Linked Vitamin E UHMWPE Tibial Insert cleared via K091956.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee Joint
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)
Non-Clinical Testing: The following non-clinical laboratory testing was performed to determine substantial equivalence: mechanical material characterization (Tensile, Small Punch, Izod Impact, and crack propagation), physical and chemical characterization ( Oxidation Index, Compressive Modulus, Poisson's Ratio, Surface Roughness, Density, Onset Melting Temperature, Peak Melting Temperature, Delta H, Degree of Crystallinity, Crosslink Density, Swell Ratio, Molecular Weight, Polydispersity Index, Lamallae Thickness, Free Radical Concentration, Vitamin E Concentration, Vitamin E Consolidation, Vitamin E Elution/Extraction, Trans-vinylene Index), tibial insert peel-out strength, wear testing, and biocompatibility. All testing has demonstrated the device is substantially equivalent to the predicate devices.
Clinical Testing: None provided
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.
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
Summary of Safety and Effectiveness
K12172741
Date: August 13, 2012
Manufacturer: Encore Medical, L.P. Trade Name: DJO Surgical 9800 Metric Blvd Austin, TX 78758
AUG 1 5 2012 Contact Person: William Garzon Regulatory Affairs Specialist Phone: (512) 834-6391 Fax: (512) 834-6313 Email: william.garzon@djoglobal.con
| Product | Product Code | Regulation and Classfication Name |
|---|---|---|
| Movation Highly Cross Linked | ||
| Vitamin E Tibial Insert | JWH, | |
| OIY | Knee Joint patellofemorotibial polymer/metal/polymer semi- | |
| constrained cemented prosthesis per 21 CFR 888.3560 |
Legally Marketed Devices to which Substantial Equivalence is Claimed:
| and and the control of the country of the country of the first and of the first and of the first and of the first and of the first and of the first and of the first and of th
| Movation Knee | K100900 | DJO Surgical |
|---|---|---|
| HXL Vitamin E Tibial Insert K091956 | DJO Surgical |
Description: The Movation Highly Cross Linked Vitamin E Tibial Inserts are manufactured from HXL VE (75KgY) ultra high molecular weight polyethylene (UHMWPE). The tibial inserts are available in 11 sizes (1,2,3,4,5,6,7,8,10,12, and 14) and 6 thicknesses (9mm -21mm) and are provided neutral in orientation. The tibial insert is identical in design to the compression molded UHMWPE Movation tibial insert cleared via K100900. The tibial insert is identical in materials to the Highly Cross-Linked Vitamin E UHMWPE Tibial Insert cleared via K091956.
The Movation Knee System is Indicated for:
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.
Comparable features to Predicate Device: Features comparable to predicate devices include same design, intended use and sterilization method.
Summary of Technologies: The Movation HXL VE Tibial Inserts are infused with a vitamin E to stabilize free-radicals and prevent oxidative degredation and then highly cross-linked to improve wear resistance. The design feature Highly Cross-Linked Vitamin Polyethylene Material UHMWPe (α-tocopherol) is equivalent to the Highly Cross-Linked Vitamin E UHMWPE Tibial Insert . cleared via K091956. The Movation HXL VE Tibial Inserts are attached to the baseplate via a super locking snap feature, equivalent to the Movation Knee cleared via K100900.
Page 1 of 2
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1
Non-Clinical Testing: The following non-clinical laboratory testing was performed to determine substantial
equivalence: mechanical material characterization (Tensile, Small Punch, Izod Impact, and crack propagation), physical and chemical characterization ( Oxidation Index, Compressive Modulus, Poisson's Ratio, Surface Roughness, Density, Onset Melting Temperature, Peak Melting Temperature, Delta H, Degree of Crystallinity, Crosslink Density, Swell Ratio, Molecular Weight, Polydispersity Index, Lamallae Thickness, Free Radical Concentration, Vitamin E Concentration, Vitamin E Consolidation, Vitamin E Elution/Extraction, Trans-vinylene Index), tibial insert peel-out strength, wear testing, and biocompatibility. All testing has demonstrated the device is substantially equivalent to the predicate devices.
Clinical Testing: None provided
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the left side of the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 15 2012
Encore Medical, L.P. % Mr. William Garzon Regulatory Affairs Specialist 9800 Metric Boulevard Austin, Texas 78758
Re: K121727
Trade/Device Name: Movation Highly Crossed Linked Vitamin E Tibial Insert Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: OIY, JWH Dated: July 13, 2012 Received: July 16, 2012
Dear Mr. Garzon:
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
3
Page 2 - Mr. William Garzon
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 (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/ycm115809.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,
fir
Mark 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): K121727
Device Name: Movation Highly Cross Linked Vitamin E Tibial Insert
Indications for Use:
The Movation Knee System is Indicated For:
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.
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)
Ander
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121727