(76 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 and are designed to work with the Arthrex dome patella components. Femoral and tibial tray components are manufactured from Cobalt-Chromium Alloy conforming to ASTM F-75. Tibial bearing and patellar components are manufactured from UHMWPE conforming to ASTM F-648.
The Arthrex iBalance® BioSync™ Femoral Components line offers the option of affixing the system's femoral components without cement through the use of a titanium scaffold porous coating (biological fixation).
The provided document is a 510(k) premarket notification for a medical device, the Arthrex iBalance® TKA System. It does not describe an AI/ML powered device, therefore, the requested information about acceptance criteria and the study proving the device meets those criteria, particularly as it relates to AI/ML performance metrics, is not present.
The document discusses the substantial equivalence of the Arthrex iBalance® TKA System to legally marketed predicate devices, focusing on design features, intended uses, materials, and mechanical testing.
Therefore, I cannot provide the requested information regarding acceptance criteria and the study proving performance for an AI-powered device, as this document pertains to a traditional orthopedic implant.
The document details the following for the Arthrex iBalance® TKA System:
- Device Description: A total knee arthroplasty system consisting of femoral components, tibial tray, tibial bearing components, and patellar components. The BioSync™ Femoral Components line extension offers the option of uncemented fixation through a titanium scaffold porous coating.
- Intended Use/Indications for Use: For individuals undergoing surgery for painful, disabling joint disease of the knee (degenerative, rheumatoid, or post-traumatic arthritis), post-traumatic loss of knee joint configuration and function, moderate varus, valgus, or flexion deformity, and revisions of previous unsuccessful knee replacement. Additional indications for posteriorly stabilized components include ligamentous instability and absent or non-functioning posterior cruciate ligament.
- Substantial Equivalence Summary: The device is considered substantially equivalent to the predicate device (K081127: Accin™ Total Knee System and K121771: Zimmer® Persona™ Personalized Knee System). Differences are considered minor and don't raise questions concerning safety and effectiveness.
- Testing Information: Fatigue, biocompatibility, metallurgical, corrosion, microstructure, strength, bonding, abrasion, and ingrowth testing information was submitted to demonstrate consistency with FDA Guidance for porous-coated orthopedic implants.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 3, 2014
Arthrex, Incorporated Mr. Leon Brown II, Ph.D. Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, FL 34108-1945
Re: K141635 Trade/Device Name: Arthrex iBalance® TKA System Regulation Number: 21CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: June 12, 2014 Received: June 19, 2014
Dear Mr. 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
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(21 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 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,
Lori A. Wiggins -S
for
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) K141635
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)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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2.6 510(K) SUMMARY
| Date Summary Prepared | August 28, 2014 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA |
| 510(k) Contact | Leon Brown II, Ph.D.Regulatory Affairs SpecialistArthrex, 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 |
| Name | 888.3565: Knee joint patellofemorotibial metal/polymer |
| CFR | 888.3565: Knee joint patellofemorotibial metal/polymerporous-coated uncemented prosthesis.888.3560: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Predicate Device | K081127: Accin™ Total Knee SystemK121771: Zimmer® Persona™ Personalized Knee System |
| Purpose of Submission | This traditional 510(k) premarket notification issubmitted to obtain clearance for the Arthrex iBalance®BioSync™ Femoral Components line extension to thecurrent Arthrex iBalance® TKA System. |
| Device Description | The Arthrex iBalance® TKA System consists of femoralcomponents, tibial tray, tibial bearing components andpatellar components. All components are available in arange of sizes to fit varying anatomical requirements.Femoral components and tibial bearing components areavailable in both posteriorly stabilized (PS) and cruciateretaining (CR) configurations. Femoral components areavailable in left and right versions and are designed towork with the Arthrex dome patella components. Femoraland tibial tray components are manufactured from Cobalt-Chromium Alloy conforming to ASTM F-75. Tibialbearing and patellar components are manufactured fromUHMWPE conforming to ASTM F-648.The Arthrex iBalance® BioSync™ Femoral Components |
| line offers the option of affixing the system's femoralcomponents without cement through the use of a titaniumscaffold porous coating (biological fixation). | |
| Intended Use | The Arthrex iBalance® TKA System is indicated for usein individuals undergoing surgery for:Painful, disabling joint disease of the knee resultingfrom degenerative arthritis, rheumatoid arthritis orpost-traumatic arthritis;Post-traumatic loss of knee joint configuration andfunctionModerate varus, valgus, or flexion deformity in whichthe ligamentous structures can be returned to adequatefunction and stability;Revisions of previous unsuccessful knee replacementor other procedure.Additional indications for posteriorly stabilizedcomponents:Ligamentous instability requiring implant bearingsurfaces with increased constraint;Absent or non-functioning posterior cruciate ligament.These devices are single use only and are intended forimplantation with bone cement, with the exception ofporous coated femoral components which can be usedcemented or uncemented (biological fixation). |
| Substantial Equivalence Summary | The Arthrex iBalance® TKA System is substantiallyequivalent to the predicate device in which the basicdesign features and intended uses are the same. Anydifferences between the Arthrex iBalance® TKA Systemand the predicate are considered minor and do not raisequestions concerning safety and effectiveness.The predicate Arthrex iBalance® TKA System is a totalknee arthroplasty system consisting of femoralcomponents, tibial tray, tibial bearing components andpatellar components. The proposed Arthrex iBalance®TKA System consists of the same four components plus aline extension to the currently available femoralcomponents. This Arthrex iBalance® BioSync™ FemoralComponents line extension is equivalent to the currentlyavailable Arthrex predicate femoral components in sizerange, material use and performance with the exception |
| that the Arthrex iBalance® BioSync™ FemoralComponents have a titanium scaffold porous coating ortheir non-articulating side. | |
| There have been no changes to the articulating surfaces ofthe femoral components. Fatigue, biocompatibility,metallurgical, corrosion, microstructure, strength,bonding, abrasion and ingrowth testing informationsubmitted demonstrates that the Arthrex iBalance®BioSync™ Femoral Components are consistent with FDAGuidance regarding porous coated orthopedic implants. | |
| Based on the indication for use, technologicalcharacteristics, and testing data submitted, Arthrex, Inc.has determined that the Arthrex iBalance® TKA Systemis substantially equivalent to currently marketed predicatedevices. |
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§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.