(76 days)
No
The document describes a traditional knee replacement system and its components, materials, and indications for use. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies listed are standard mechanical and material tests for orthopedic implants.
Yes.
The device is a knee replacement system intended to treat painful, disabling joint disease, which is a therapeutic purpose.
No
This device is an implantable orthopedic device (knee replacement system) used for surgical treatment of knee joint diseases, not for diagnosis.
No
The device description explicitly states it consists of physical components (femoral components, tibial tray, tibial bearing components, patellar components) made of materials like Cobalt-Chromium Alloy and UHMWPE, 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 deformities. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the components of a knee replacement system (femoral, tibial, patellar components) made from materials like Cobalt-Chromium Alloy and UHMWPE. These are materials used for implants, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a surgical implant used in the body 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
MBH, JWH
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 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).
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)
Fatigue, biocompatibility, metallurgical, corrosion, microstructure, strength, bonding, abrasion and ingrowth testing information submitted demonstrates that the Arthrex iBalance® BioSync™ Femoral Components are consistent with FDA Guidance regarding porous coated orthopedic implants.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, resembling a bird-like shape.
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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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
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2.6 510(K) SUMMARY
| Date Summary Prepared | August 28, 2014 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Leon Brown II, Ph.D. |
| Regulatory Affairs Specialist | |
| 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 | 888.3565: Knee joint patellofemorotibial metal/polymer |
| 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: Accin™ Total Knee System |
| K121771: Zimmer® Persona™ Personalized Knee System | |
| Purpose of Submission | This traditional 510(k) premarket notification is |
| submitted to obtain clearance for the Arthrex iBalance® | |
| BioSync™ Femoral Components line extension to the | |
| current Arthrex iBalance® TKA 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 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). | |
| 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 | |
| functionModerate 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 Arthrex iBalance® TKA System is substantially |
| equivalent to the predicate device in which the basic | |
| design features and intended uses are 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 predicate Arthrex iBalance® TKA System is a total
knee arthroplasty system consisting of femoral
components, tibial tray, tibial bearing components and
patellar components. The proposed Arthrex iBalance®
TKA System consists of the same four components plus a
line extension to the currently available femoral
components. This Arthrex iBalance® BioSync™ Femoral
Components line extension is equivalent to the currently
available Arthrex predicate femoral components in size
range, material use and performance with the exception |
| that the Arthrex iBalance® BioSync™ Femoral
Components have a titanium scaffold porous coating or
their non-articulating side. | |
| There have been no changes to the articulating surfaces of
the femoral components. Fatigue, biocompatibility,
metallurgical, corrosion, microstructure, strength,
bonding, abrasion and ingrowth testing information
submitted demonstrates that the Arthrex iBalance®
BioSync™ Femoral Components are consistent with FDA
Guidance regarding porous coated orthopedic implants. | |
| Based on the indication for use, technological
characteristics, and testing data submitted, Arthrex, Inc.
has determined that the Arthrex iBalance® TKA System
is substantially equivalent to currently marketed predicate
devices. | |
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