(98 days)
Not Found
No
The summary describes a traditional knee replacement system with mechanical components and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is indicated for use in individuals undergoing surgery for painful and disabling joint disease of the knee, including degenerative, rheumatoid, and post-traumatic arthritis, which are conditions that benefit from therapeutic intervention.
No
Explanation: The device is an orthopedic implant system (Total Knee Arthroplasty System) used for surgical replacement of the knee joint in individuals with severe knee conditions. Its intended use is therapeutic, specifically to replace the knee joint, rather than to diagnose a condition.
No
The device description clearly states it consists of physical components like femoral components, tibial tray, tibial bearing components, and patellar components, made from materials like cobalt-chromium alloy, titanium alloy, and UHMWPE. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a surgical implant for treating painful and disabling joint disease of the knee. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device description details components of a knee replacement system (femoral components, tibial tray, tibial bearing components, patellar components) made from materials like cobalt-chromium alloy, titanium alloy, and UHMWPE. These are all materials used for surgical implants.
- Anatomical Site: The anatomical site is the knee, which is a part of the human body where a surgical procedure is performed.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This device does not perform any such tests on samples.
The Arthrex iBalance® TKA System is a surgical implant used for total knee arthroplasty (knee replacement surgery).
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, as well as cemented and uncemented (biological fixation) versions and are designed to work with the Arthrex dome patella components. Femoral and tibial tray components are manufactured from either cobalt-chromium alloy conforming to ASTM F75 or titanium alloy conforming to ASTM F136. Tibial bearing and patellar components are manufactured from UHMWPE conforming to ASTM F648.
The Arthrex iBalance® Modular Tibial Tray line extension offers the option of using stem extensions and/or tibial augments in a tray manufactured from titanium alloy. The Arthrex iBalance® Modular Tibial Tray would have two additional larger sizes—coming in sizes 1-10 rather than the size 1-8 range of the predicate. Two additional larger sized tibial bearing components and femoral components, size 9 & size 10, are also being offered.
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
Fatigue, wear, interlock and assembly/disassembly testing demonstrates Arthrex iBalance® Modular Tibial Tray compliance with FDA Guidance and industry standards.
Key Metrics
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 features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, composed of three overlapping profiles facing to the right. The profiles are rendered in a dark color, contrasting with the white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 16, 2015
Arthrex, Incorporated Leon Brown II, Ph.D. Regulatory Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K152252
Trade/Device Name: Arthrex iBalance® TKA System Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: September 22, 2015 Received: September 23, 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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Expiration Date: January 31, 2017
See PRA Statement below
Indications for Use
510(k) Number (if known)
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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2.6 510(K) SUMMARY
| Date Summary Prepared | November 10, 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 |
| Primary Product Code - | |
| Classification Name | |
| CFR | MBH |
| 888.3565: Knee joint patellofemorotibial metal/polymer | |
| porous-coated uncemented prosthesis. | |
| Secondary Product Code - | |
| Classification Name | |
| CFR | JWH |
| 888.3560: Prosthesis, Knee, Patellofemorotibial, Semi- | |
| Constrained, Cemented, Polymer/Metal/Polymer | |
| Predicate Device | K081127: AccinTM Total Knee System |
| K122765: Zimmer® PersonaTM Knee System | |
| Purpose of Submission | This traditional 510(k) premarket notification is |
| submitted to obtain clearance for the Arthrex iBalance® | |
| Modular Tibial Tray 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, as well as cemented | |
| and uncemented (biological fixation) versions and are | |
| designed to work with the Arthrex dome patella | |
| components. Femoral and tibial tray components are | |
| manufactured from either cobalt-chromium alloy | |
| conforming to ASTM F75 or titanium alloy conforming to | |
| ASTM F136. Tibial bearing and patellar components are | |
| manufactured from UHMWPE conforming to ASTM | |
| F648. | |
| The Arthrex iBalance® Modular Tibial Tray line | |
| extension offers the option of using stem extensions | |
| and/or tibial augments in a tray manufactured from | |
| titanium alloy. The Arthrex iBalance® Modular Tibial | |
| Tray would have two additional larger sizes—coming in | |
| sizes 1-10 rather than the size 1-8 range of the predicate. | |
| Two additional larger sized tibial bearing components and | |
| femoral components, size 9 & size 10, are also being | |
| offered. | |
| 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 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 tibial trays. This | |
| Arthrex iBalance® Modular Tibial Tray line extension is | |
| equivalent to the currently available Arthrex predicate | |
| tibial trays in size range, use and performance, with the | |
| exception that the Arthrex iBalance® Modular Tibial Tray | |
| line extension offers the option of using stem extensions | |
| and/or tibial augments in a tray manufactured from | |
| titanium alloy. | |
| | |
| Fatigue, wear, interlock and assembly/disassembly testing | |
| demonstrates Arthrex iBalance® Modular Tibial Tray | |
| compliance with FDA Guidance and industry standards. | |
| | |
| on the indication for use, technological
Based | |
| 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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