(27 days)
The Arthrex iBalance TKA System is indicated for use in individuals undergoing surgery for:
• Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis;
• Post-traumatic loss of knee joint configuration and function;
• Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability;
• Revisions of previous unsuccessful knee replacement or other procedure.
Additional indications for posteriorly stabilized components:
• Ligamentous instability requiring implant bearing surfaces with increased constraint;
• Absent or non-functioning posterior cruciate ligament.
These devices are single use only and are intended for implantation with bone cement.
The Arthrex iBalance Total Knee System consists of femoral devices, tibial trays, tibial bearing and patellar devices. All devices are available in a range of sizes to fit varying anatomical requirements. Femoral devices and tibial bearing devices are available in both posteriorly stabilized (PS) and cruciate retaining (CR) configurations. Femoral devices are available in left and right versions and are designed to work with the Arthrex dome patella devices. Femoral and tibial tray devices are manufactured from Cobalt Chromium Alloy conforming to ASTM F75. Tibial bearing and patellar devices are manufactured from UHMWPE conforming to ASTM F648.
The Arthrex iBalance Patella Implant, Dome subject of this application is comparable to the system's current dome patella devices with the exception that the proposed device will be offered in a larger size to further compliment the Arthrex iBalance Total Knee System product offering.
The provided document is an FDA 510(k) premarket notification for the Arthrex iBalance Patella Implant, Dome. It states that the device is substantially equivalent to a predicate device and provides information on its intended use, design, and materials.
However, this document does NOT contain information about acceptance criteria, device performance metrics (such as accuracy, sensitivity, specificity for a diagnostic device), sample sizes for test sets or training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types, which are typically associated with AI/ML-driven medical device submissions.
The document is for a traditional medical device (a knee implant), not an AI/ML device. Therefore, the requested information (related to AI/ML evaluation) cannot be extracted from this document.
To fulfill the request, a document describing the evaluation of an AI/ML-driven medical device would be needed.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized image of three faces in profile, stacked on top of each other. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 19, 2014
ARTHREX, Incorporated Ms. Laura Medlin Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K143047
Trade/Device Name: Arthrex iBalance Patella Implant, Dome Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: October 20, 2014 Received: October 23, 2014
Dear Ms. Medlin:
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
{1}------------------------------------------------
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K143047
Device Name
Arthrex iBalance Patella Implant, Dome
Indications for Use (Describe)
The Arthrex iBalance TKA System is indicated for use in individuals undergoing surgery for:
-
Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis:
-
Post-traumatic loss of knee joint configuration and function;
-
Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability;
-
Revisions of previous unsuccessful knee replacement or other procedure.
Additional indications for posteriorily stabilized components:
- Ligamentous instability requiring implant bearing surfaces with increased constraint;
- Absent or non-functioning posterior cruciate ligament.
These devices are single use only and are intended for implantation with bone cement.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the Arthrex logo with the text "SPECIAL 510(K): ARTHREX IBALANCE® PATELLA DOME IMPLANT" next to it. The Arthrex logo is a stylized depiction of a pair of scissors. The text indicates that the product is a patella dome implant.
2.6 510K SUMMARY OF SAFETY AND EFFECTIVENESS
| Date Summary Prepared | October 20, 2014 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA |
| 510(k) Contact | Laura MedlinRegulatory Affairs AssociateArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext.72005Fax: 239/598.5508Email: Laura.Medlin@Arthrex.com |
| Trade Name | Arthrex iBalance Patella Implant, Dome |
| Common Name | Knee Prosthesis |
| Product Code,Classification Name, CFR | JWH21 CFR 888.3560: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. |
| Predicate Device | K133854: Arthrex iBalance TKA System, Patella Implant, DomeK081127: Accin Total Knee System |
| Purpose of Submission | This special 510(k) premarket notification is submitted to obtain clearance for aline extension to the current patella dome devices of the Arthrex iBalance TotalKnee System. |
| Device Description | The Arthrex iBalance Total Knee System consists of femoral devices, tibial trays,tibial bearing and patellar devices. All devices are available in a range of sizes tofit varying anatomical requirements. Femoral devices and tibial bearing devicesare available in both posteriorly stabilized (PS) and cruciate retaining (CR)configurations. Femoral devices are available in left and right versions and aredesigned to work with the Arthrex dome patella devices. Femoral and tibial traydevices are manufactured from Cobalt Chromium Alloy conforming to ASTM F75.Tibial bearing and patellar devices are manufactured from UHMWPE conformingto ASTM F648.The Arthrex iBalance Patella Implant, Dome subject of this application iscomparable to the system's current dome patella devices with the exception thatthe proposed device will be offered in a larger size to further compliment theArthrex iBalance Total Knee System product offering. |
| Intended Use | The Arthrex iBalance TKA System is indicated for use in individuals undergoingsurgery for:• Painful, disabling joint disease of the knee resulting from degenerativearthritis, rheumatoid arthritis or post-traumatic arthritis;• Post-traumatic loss of knee joint configuration and function;• Moderate varus, valgus, or flexion deformity in which the ligamentousstructures can be returned to adequate function and stability;• Revisions of previous unsuccessful knee replacement or otherprocedure.Additional indications for posteriorly stabilized components:• Ligamentous instability requiring implant bearing surfaces withincreased constraint;• Absent or non-functioning posterior cruciate ligament.These devices are single use only and are intended for implantation with bonecement. |
| SubstantialEquivalence Summary | The Arthrex iBalance Patella Implant, Dome is substantially equivalent to thepredicate devices in which the basic design features and intended uses are thesame. Any differences between the Arthrex iBalance Patella Implant, Dome andthe predicates are considered minor and do not raise questions concerning safety |
| and effectiveness. | |
| The predicate Arthrex iBalance TKA System is a total knee arthroplasty systemconsisting of femoral devices, tibial trays, tibial bearing and patellar devices. Thisapplication serves to introduce one (1) new size of the patella dome device. Noadditional changes have been made to the previously cleared devices of theArthrex iBalance TKA System as a result of this application. | |
| The subject Arthrex iBalance Patella Implant, Dome is equivalent to the currentlyavailable predicate Patella Implant, Domes (K133854) in which the basic featuresand intended uses are the same. Any differences between the Arthrex iBalancePatella Implant, Dome and the predicates are considered minor and do not raisequestions concerning safety and effectiveness. | |
| The proposed patella dome device is substantially equivalent to the predicatedevices in regards to its intended use, design, size range, and material. Anevaluation of the geometries and design features of the predicate and subjectdevices demonstrated that the proposed device provides adequate stability tosupport the use of the Arthrex iBalance Patella Implant, Dome for the referencedindications. | |
| Based on the indication for use, technological characteristics, and the comparisonto the predicate device, Arthrex, Inc. has determined that the Arthrex iBalancePatella Implant, Dome is substantially equivalent to currently marketed predicatedevices. |
{4}------------------------------------------------
Arthrex. 6 SPECIAL 510(K): ARTHREX IBALANCE® PATELLA DOME IMPLANT
§ 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.