(80 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, with the exception of porous coated femoral components which can be used cemented or uncemented (biological fixation).
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.
This document is a 510(k) premarket notification for a medical device called the "Arthrex iBalance® TKA System", a knee prosthesis. It details a submission to obtain clearance for a line extension that adds a new smaller-sized component to the existing system.
Based on the provided text, there is no information present regarding acceptance criteria, reported device performance in those terms, or a specific study designed to "prove" the device meets acceptance criteria in the format of a clinical or comparative effectiveness study.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through various means, primarily through the assertion that the new component size does not alter the fundamental safety and effectiveness of the system.
Here's a breakdown of the specific points requested, based on the available information:
1. Table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the document as a formal table with acceptance criteria linked to specific performance metrics. The document broadly states: "The fatigue, wear and interlock testing demonstrates the Arthrex iBalance® TKA System remains in compliance with FDA Guidance and industry standards." This implies that the device did meet compliance standards, but the specific, quantified criteria and results are not detailed.
2. Sample size used for the test set and the data provenance:
- Sample Size: This information is not provided. The text mentions "fatigue, wear and interlock testing" but does not specify the number of components or iterations tested.
- Data Provenance: This information is not provided. It's implied the testing was conducted by Arthrex, Inc., but details like country of origin, retrospective or prospective nature are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided. The testing mentioned (fatigue, wear, interlock) are mechanical engineering tests, not clinical studies requiring expert ground truth establishment in the traditional sense of diagnostic accuracy or clinical outcomes.
4. Adjudication method for the test set:
This information is not applicable and not provided for the same reasons as point 3. Mechanical tests typically rely on predefined engineering specifications for pass/fail, not expert adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable and not provided. The device is an orthopedic implant (knee prosthesis), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to "human readers improving with AI" would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided. As mentioned, this is a physical medical device (a knee prosthesis), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the mechanical testing would be the established engineering specifications and industry standards for fatigue, wear, and interlock performance of knee prostheses. The document states compliance with "FDA Guidance and industry standards." There's no mention of expert consensus, pathology, or outcomes data being used as ground truth for this specific submission for a line extension.
8. The sample size for the training set:
This information is not applicable and not provided. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable and not provided for the same reasons as point 8.
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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
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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 BoulevardNaples, FL 34108-1945 USA |
| 510(k) Contact | Leon Brown II, Ph.D.Regulatory Project ManagerArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 72028Fax: 239/598.5508Email: Leon.Brown@Arthrex.com |
| Trade Name | Arthrex iBalance® TKA System |
| Common Name | Knee Prosthesis |
| Product Code -Classification | JWH, MBH |
| NameCFR | 888.3565: Knee joint patellofemorotibialmetal/polymer porous-coated uncemented prosthesis.888.3560: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Predicate Device | K081127: Arthrex iBalance® TKA SystemK133854: Arthrex iBalance® TKA System |
| Purpose of Submission | This special 510(k) premarket notification issubmitted to obtain clearance for a line extension tothe Arthrex iBalance® TKA System which wouldadd a new smaller sized component to the system. |
| Device Description | The Arthrex iBalance® TKA System consists offemoral components, tibial tray, tibial bearingcomponents and patellar components. Allcomponents are available in a range of sizes to fitvarying anatomical requirements. Femoralcomponents and tibial bearing components areavailable in both posteriorly stabilized (PS) andcruciate retaining (CR) configurations. Femoralcomponents are available in left and right versions |
| as well as cemented and uncemented (biologicalfixation) versions and are designed to work withthe Arthrex dome patella components. Tibialbearing components are offered in PS, CR and CRPlus configurations. | |
| The proposed Arthrex iBalance® TKA System lineextension of this submission adds an additionalsmaller tibial bearing component size (i.e. Size 1)to the product offering. | |
| Intended Use | The Arthrex iBalance® TKA System is indicatedfor use in individuals undergoing surgery for:• Painful, disabling joint disease of the kneeresulting from degenerative arthritis,rheumatoid arthritis or post-traumatic arthritis;• Post-traumatic loss of knee joint configurationand function• Moderate varus, valgus, or flexion deformity inwhich the ligamentous structures can bereturned to adequate function and stability;• Revisions of previous unsuccessful kneereplacement or other procedure.Additional indications for posteriorly stabilizedcomponents:• Ligamentous instability requiring implantbearing surfaces with increased constraint;• Absent or non-functioning posterior cruciateligament. |
| These devices are single use only and are intendedfor implantation with bone cement, with theexception of porous coated femoral componentswhich can be used cemented or uncemented(biological fixation). | |
| Substantial EquivalenceSummary | The proposed Arthrex iBalance® TKA Systemadds additional sizes to the existing system. TheArthrex iBalance® TKA System is substantiallyequivalent 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.
§ 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.