(48 days)
No
The document describes a traditional knee replacement system made of standard materials and does not mention any AI or ML components or functionalities.
Yes
The device is a knee replacement system used to treat painful and disabling joint diseases, which aligns with the definition of a therapeutic device designed to cure, mitigate, treat, or prevent disease.
No
This device is described as an implantable system (femoral components, tibial tray, etc.) for knee replacement surgery, not a tool for diagnosing conditions. Its primary function is to replace damaged joint structures, not to identify or characterize diseases.
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. This indicates it is a hardware-based medical device, not software-only.
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 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 in vitro diagnostic tests.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.) or providing information for diagnosis, monitoring, or screening.
In vitro diagnostics are tests performed on samples taken from the human body to provide information about a person's health. This device is a surgical implant used to replace a damaged knee 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 bone cement.
Product codes
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 (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.
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)
Material properties of the gamma UHMWPE components have been fully characterized per ASTM F2565. Gamma sterilization had minimal effects on the mechanical properties of the PE, and the properties meet those listed in ASTM standard F648 for Type 2 PE. The mechanical testing data submitted demonstrates that there is no significant difference in mechanical strength between EtO and Gamma specimens.
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
§ 888.3560 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
K133342 Page 1 of 3
DEC 1 7 2013
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2.6 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Date Summary Prepared | December 13, 2013 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Mariela Cabarcas |
| Regulatory Affairs Project Manager | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553. ext. 71246 | |
| Fax: 239/598.5508 | |
| Email: mcabarcas@arthrex.com | |
| Trade Name | Arthrex iBulance® TKA System |
| Common Name | Knee Prosthesis |
| Product Code -Classification | |
| Name | |
| CFR | JWH |
| 888.3560: Prosthesis. Knee, Patellofemorotibial, Semi- | |
| Constrained. Cemented. Polymer/Metal/Polymer | |
| Predicate Device | K081127: Accin™ Total Knee System |
| Purpose of Submission | special 510(k) premarket notification |
| This | |
| is | |
| intended to address the use of Gamma Irradiation | |
| sterilization method on the UHMWPE 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 | |
| (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. | |
| 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 devices, in which the basic | |
| design features and intended uses are the same. Any | |
| differences between the Arthrex iBalance® TKA System | |
| and the predicates are considered minor and do not raise | |
| questions concerning safety and effectiveness. | |
| In the predicates, Gamma Irradiation sterilization is used | |
| for the Chromium Alloy components, and EtO | |
| sterilization is used for the UHMWPE components. In the | |
| proposed Arthrex iBalance® TKA System, the UHMWPE | |
| components will also undergo Gamma Irradiation | |
| sterilization. | |
| Material properties of the gamma UHMWPE components | |
| have been fully characterized per ASTM F2565. Gamma | |
| sterilization had minimal effects on the mechanical | |
| properties of the PE, and the properties meet those listed | |
| in ASTM standard F648 for Type 2 PE. The mechanical | |
| testing data submitted demonstrates that there is no | |
| significant difference in mechanical strength between | |
| EtO and Gamma specimens. | |
| Based on the indication for use, technological | |
| characteristics, and the summary of data submitted. | |
| Arthrex, Inc. has determined that the Arthrex iBalance® |
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| TKA System is substantially equivalent to currently marketed predicate devices. |
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and the comments of the comments of
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle.
Food and Drug Administration 10903 New Hampshire Avenue -Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 17, 2013
Arthrex, Incorporated Ms. Mariela Cabarcas Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108
Re: K133342
Trade/Device Name: Arthrex iBalance® TKA System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: October 30, 2013 Received: November 4, 2013
Dear Ms. Cabarcas:
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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Ms. Mariela Cabarcas
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21) CFR 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/ReportalProblem/default.htm for the CDRH3s 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.
Ronald#19ean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K133342
INDICATIONS FOR USE
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; ●
- 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 bone cement.
Prescription Use _ AND/OR Over-The-Counter Use (Per 21 CER 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 I
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices