(244 days)
No
The summary describes a mechanical implant (tibial bearing) and its intended use and testing. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The device is a knee implant used to treat painful osteoarthritis or post-traumatic arthritis and to correct functional deformities, which are therapeutic interventions.
No
Explanation: The device description and intended use indicate it is an implantable medical device (tibial bearing for knee arthroplasty), not a tool for diagnosing medical conditions. It performs a therapeutic function by replacing a joint.
No
The device description clearly states that the device is a tibial bearing made from Vitamin E blended UHMWPE, which is a physical implantable component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases, conditions, or determine the state of health. Examples include blood tests, urine tests, and genetic tests.
- This device is an implantable medical device. It is a component of a knee replacement system designed to be surgically implanted into a patient's knee joint.
The description clearly states the device's intended use is for unicompartmental knee arthroplasty and that the components are intended for implantation. This is the definition of an implantable medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Arthrex iBalance UKA System components are for use in Unicompartmental knee arthroplasty as a result of:
· Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis;
- · Correction of functional deformities;
- · Revision of previous unsuccessful unicompartmental knee replacement or other procedure;
- · As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.
These components are single use only and are intended for implantation with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
HSX, OIY
Device Description
The tibial bearing is made from Vitamin E blended UHMWPE and is available in 6 sizes, ranging from 8-14mm in thickness. The design is symmetrical and may be used for either the medial or lateral compartment of the left or right knee in unicompartmental arthroplasty as part of the Arthrex iBalance UKA System.
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)
Shear interlock testing was conducted on the proposed Vitamin E blended UHMWPE tibial bearing to demonstrate that the maximum moment force meets the acceptance criteria established in the predicate 510(k).
Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications.
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.
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
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
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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 seal 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.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 15, 2016
Arthrex, Inc. David Rogers Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K161060
Trade/Device Name: Arthrex iBalance UKA System Vitamin E Tibial Bearing Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: HSX, OIY Dated: November 22, 2016 Received: November 23, 2016
Dear David Rogers:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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/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/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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K161060
Device Name
Arthex iBalance UKA System Vitamin E Tibial Bearing
Indications for Use (Describe)
The Arthrex iBalance UKA System components are for use in Unicompartmental knee arthroplasty as a result of:
· Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis;
- · Correction of functional deformities;
- · Revision of previous unsuccessful unicompartmental knee replacement or other procedure;
- · As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.
These components are single use only and are intended for implantation with bone cement.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Date Summary Prepared | December 5, 2016 |
|---|---|
| Manufacturer/Distributor/ | |
| Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | David L Rogers |
| Project Manager, Regulatory Affairs | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext. 71924 | |
| Fax: 239/598.5508 | |
| Email: david.rogers@arthrex.com | |
| Trade Name | Arthrex iBalance UKA System Vitamin E Tibial Bearing |
| Common Name | Unicompartmental Knee System |
| Primary Product Code - | |
| Classification Name | |
| CFR | HSX |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Polymer | |
| 21 CFR 888.3520 | |
| Secondary Product Code - | |
| Classification Name | |
| CFR | OIY |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, | |
| Cemented, Polymer + Additive/Metal/Polymer + Additive | |
| 21 CFR 888.3560 | |
| Predicate Device | K060670: Accin UNI-Knee System |
| Reference Predicate Device | K153586: Arthrex iBalance TKA System |
| Purpose of Submission | This special 510(k) premarket notification is submitted to obtain |
| clearance for a line extension to the Arthrex iBalance UKA | |
| System, which would add a Vitamin E blended UHMWPE tibial | |
| bearing component. | |
| Device Description | The tibial bearing is made from Vitamin E blended UHMWPE and |
| is available in 6 sizes, ranging from 8-14mm in thickness. The | |
| design is symmetrical and may be used for either the medial or | |
| lateral compartment of the left or right knee in | |
| unicompartmental arthroplasty as part of the Arthrex iBalance | |
| UKA System. | |
| Indications for Use | Arthrex iBalance UKA System components are intended for use |
| in unicompartmental knee arthroplasty as a result of: | |
| Moderately disabling joint disease of the knee resulting | |
| from painful osteoarthritis or post traumatic arthritis; Correction of functional deformities; Revision of previous unsuccessful unicompartmental | |
| knee replacement or other procedure; As an alternative to tibial osteotomy in patients with | |
| unicompartmental osteoarthritis. | |
| These components are single use only and are intended for | |
| implantation with bone cement. | |
| Substantial Equivalence | |
| Summary | The proposed Arthrex iBalance UKA System Vitamin E Tibial |
| Bearing is similar to the predicate device, in which the basic | |
| design features and intended uses are the same. | |
| The Vitamin E material used for the tibial bearing has been | |
| previously cleared under K153586. | |
| Shear interlock testing was conducted on the proposed Vitamin E | |
| blended UHMWPE tibial bearing to demonstrate that the | |
| maximum moment force meets the acceptance criteria | |
| established in the predicate 510(k). | |
| Bacterial endotoxin per EP 2.6.14/USP was conducted to | |
| demonstrate that the device meets pyrogen limit specifications. | |
| Based on the indication for use, technological characteristics, and | |
| the summary of data submitted, Arthrex, Inc. has determined | |
| that the Arthrex iBalance UKA System Vitamin E Tibial Bearing is | |
| substantially equivalent to currently marketed predicate devices. |
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