(70 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.
No
The device is a knee replacement system used in surgery to treat disabling joint diseases, loss of knee joint configuration and function, and deformities. While it addresses medical conditions, it is a prosthetic device for repair and replacement, not a device that itself delivers therapy (e.g., electrical stimulation, drug delivery, light therapy).
No
The Arthrex iBalance® TKA System is an implantable medical device used in total knee arthroplasty, which is a surgical procedure to replace a damaged knee joint. Its intended use and device description clearly indicate it is a therapeutic device for treatment rather than a diagnostic tool for identifying a condition.
No
The device description explicitly states that the system consists of physical components (femoral components, tibial tray, tibial bearing components, and patellar components) made from 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 painful and disabling joint disease of the knee. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details the components of a knee replacement system (femoral components, tibial tray, tibial bearing components, 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.), reagents, or any other elements typically associated with in vitro diagnostics.
In summary, the Arthrex iBalance® TKA System is a surgical implant designed to replace a damaged knee joint, which falls under the category of a medical device for treatment, not an in vitro diagnostic device for diagnosis.
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; .
- o 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. 0
These devices are single use only and are intended for implantation with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
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 CR Plus line of tibial bearing components are comparable to the system's current tibial bearing components with the exception of having dimensional specifications modification in order to offer a taller anterior lip for each size of the tibial bearing component.
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 contact stress, constraint, interlock and range of motion testing information submitted demonstrates that there is no significant difference in performance between the proposed and predicate devices.
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.
0
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| 2.6 510(K) SUMMARY | |||||
|---|---|---|---|---|---|
| all difference than and consisted of the consisted on the consisted in the compressional of Child Children and Children and Children and Children and Children and Children an | |||||
| would and any any ------------------------------------------------------------------------------------------------------------------------------------------------------------ |
i
・
-FEB 2 7 2014
| Date Summary Prepared | January 19, 2013 |
|---|---|
| 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 |
| Name | 888.3560: Prosthesis, Knee, Patellofemorotibial, Semi- |
| CFR | Constrained. Cemented, Polymer/Metal/Polymer |
| Predicate Device | K081127: Accin™ Total Knee System |
| Purpose of Submission | This special 510(k) premarket notification is submitted to |
| obtain clearance for the CR Plus line extension to the | |
| current tibial bearing components of the 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 CR Plus line of tibial bearing components are
comparable to the system's current tibial bearing
components with the exception of having dimensional
specifications modification in order to offer a taller |
| | anterior lip for each size of the tibial bearing component. |
| 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. |
| 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 bearing
components. This line extension is referred to as the CR
Plus tibial bearing components. The CR Plus tibial
bearing components are equivalent to the currently
available predicate tibial bearing components in size
range. thickness at the sulci, material, use and
performance with the exception that the CR Plus tibial
bearing components have a dimensional specifications
modification to provide a taller anterior lip to the |
1
:
·
2
.
| component. |
|---|
| The contact stress, constraint, interlock and range of motion testing information submitted demonstrates that there is no significant difference in performance between the proposed and predicate devices. |
| 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. |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus, which is a symbol of medicine, with three lines forming the wings. The caduceus is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
10903 New Hampshire A Document Control Center - WO Silver Spring, MD 20993-0007
February 27, 2014
Arthrex, Incorporated Leon Brown II. PhD Regulatory Affairs Specialist 1370 Creekside Boulevard Naples. Florida 34108-1945
Re: K133854
Trade/Device Name: Arthrex iBalance"TKA System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patcllofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: January 20. 2014 Received: January 23, 2014
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 is 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
4
Page 2 - Leon Brown II, PhD
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 (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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/Reportal?roblem/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 Small Manufacturers. International and Consumer Assistance 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.
Sincerely yours,
Vincent J. Devlin -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
2.5 INDICATIONS FOR USE
Indications for Use
K133854 510(k) Number (if known):
Device Name: Arthrex iBalance® TKA System
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; .
- o 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. 0
These devices are single use only and are intended for implantation with bone cement.
Prescription Use _ V_ AND/OR Over-The-Counter Use __ (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
PAGE I of 1
Image /page/5/Picture/20 description: The image contains text that reads "Casey L. Hanley, Ph.D." above a horizontal line. Below the line, the text reads "Division of Orthopedic Devices". The text is surrounded by a decorative border, giving it a stamp-like appearance.
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