(80 days)
Not Found
No
The summary describes a total knee arthroplasty system with various components and sizes. There is no mention of AI, ML, image processing, or any data-driven algorithms for diagnosis, treatment planning, or device function. The performance studies focus on mechanical testing (fatigue, wear, interlock).
Yes
The device is a knee replacement system intended for individuals with painful and disabling joint disease, aiming to restore function and alleviate symptoms.
No
Explanation: The device description states that the Arthrex iBalance® TKA System consists of components (femoral, tibial, patellar) intended for implantation in individuals undergoing surgery for knee joint conditions. This indicates it is a therapeutic device, not a diagnostic one. Its purpose is to treat or replace, not to identify or characterize a disease.
No
The device description explicitly states that the system consists of physical components such as femoral components, tibial tray, tibial bearing components, and patellar components, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating knee joint diseases and injuries. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details physical components like femoral components, tibial trays, and patellar components, which are parts of a knee replacement system.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used to replace a damaged joint.
N/A
Intended Use / Indications for Use
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 stabilization 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 the exception of porous coated femoral components which can be used cemented (biological fixation).
Product codes (comma separated list FDA assigned to the subject device)
JWH, MBH
Device Description
The Arthrex iBalance® TKA System consists of femoral components, tibial tray, tibial bearing components and patellar components. All components are available in a range of sizes to fit varying anatomical requirements. Femoral components and tibial bearing components are available in both posteriorly stabilized (PS) and cruciate retaining (CR) configurations. Femoral components are available in left and right versions as well as cemented and uncemented (biological fixation) versions and are designed to work with the Arthrex dome patella components. Tibial bearing components are offered in PS, CR and CR Plus configurations.
The proposed Arthrex iBalance® TKA System line extension of this submission adds an additional smaller tibial bearing component size (i.e. Size 1) to the product offering.
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)
The fatigue, wear and interlock testing demonstrates the Arthrex iBalance® TKA System remains in compliance with FDA Guidance and industry standards.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 12, 2015
Arthrex, Incorporated Leon Brown II, Ph.D. Regulatory Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K152382 Trade/Device Name: Arthrex iBalance® TKA System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, MBH Dated: October 15, 2015 Received: October 16, 2015
Dear Dr. Brown:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/ResourcesforYou/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
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Indications for Use
510(k) Number (if known) K152382
Device Name
Arthrex iBalance® TKA System
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 posteriorly stabilization 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 the exception of porous coated femoral components which can be used cemented (biological fixation).
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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2.5 510(K) SUMMARY
| Date Summary Prepared | August 26, 2015 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Leon Brown II, Ph.D. |
| Regulatory Project Manager | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext. 72028 | |
| Fax: 239/598.5508 | |
| Email: Leon.Brown@Arthrex.com | |
| Trade Name | Arthrex iBalance® TKA System |
| Common Name | Knee Prosthesis |
| Product Code -Classification | JWH, MBH |
| Name | |
| CFR | 888.3565: Knee joint patellofemorotibial |
| metal/polymer porous-coated uncemented prosthesis. | |
| 888.3560: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | |
| Predicate Device | K081127: Arthrex iBalance® TKA System |
| K133854: Arthrex iBalance® TKA System | |
| Purpose of Submission | This special 510(k) premarket notification is |
| submitted to obtain clearance for a line extension to | |
| the Arthrex iBalance® TKA System which would | |
| add a new smaller sized component to the system. | |
| Device Description | The Arthrex iBalance® TKA System consists of |
| femoral components, tibial tray, tibial bearing | |
| components and patellar components. All | |
| components are available in a range of sizes to fit | |
| varying anatomical requirements. Femoral | |
| components and tibial bearing components are | |
| available in both posteriorly stabilized (PS) and | |
| cruciate retaining (CR) configurations. Femoral | |
| components are available in left and right versions | |
| as well as cemented and uncemented (biological | |
| fixation) versions and are designed to work with | |
| the Arthrex dome patella components. Tibial | |
| bearing components are offered in PS, CR and CR | |
| Plus configurations. | |
| The proposed Arthrex iBalance® TKA System line | |
| extension of this submission adds an additional | |
| smaller tibial bearing component size (i.e. Size 1) | |
| to the product offering. | |
| Intended Use | 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, with the | |
| exception of porous coated femoral components | |
| which can be used cemented or uncemented | |
| (biological fixation). | |
| Substantial Equivalence | |
| Summary | The proposed Arthrex iBalance® TKA System |
| adds additional sizes to the existing system. The | |
| Arthrex iBalance® TKA System is substantially | |
| equivalent to the predicate device in which the |
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basic design features and intended use are the same. Materials, indications for use, technological characteristics, packaging, storage, and sterilization remain the same. Any differences between the Arthrex iBalance® TKA System and the predicate are considered minor and do not raise questions concerning safety and effectiveness.
The fatigue, wear and interlock testing demonstrates the Arthrex iBalance® TKA System remains in compliance with FDA Guidance and industry standards.
Based on the indication for use, technological characteristics, and the summary of mechanical testing data submitted, Arthrex, Inc. has determined that the Arthrex iBalance® TKA System is substantially equivalent to currently marketed predicate devices.