(214 days)
Not Found
No
The summary describes a mechanical implant (a button for tendon/ligament fixation) and its associated insertion tool. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The performance studies focus on mechanical strength and MR compatibility, not algorithmic performance.
No
The device is a fixation button used in orthopedic repair, designed to hold tissue or bone in place. While it aids in the repair process of conditions that might cause pain or dysfunction, it doesn't directly treat or cure a disease or condition itself by restoring health or alleviating symptoms in the same way a therapeutic device might (e.g., drug delivery system, pain relief device). Its role is primarily structural support during recovery, not active therapy.
No
The device is a button for the fixation of bone or soft tissue to bone, used in surgical repairs. It is an implantable device used during treatment, not to diagnose a condition.
No
The device description explicitly states the device is made of titanium alloy and is a physical button preloaded onto a driver/inserter. This indicates a hardware component, not a software-only device.
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 device used for fixation of bone or soft tissue to bone during surgical procedures. This is a mechanical function within the body.
- Device Description: The description details a titanium alloy button with holes for suture, designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used to physically repair or reconstruct tissues within the body.
N/A
Intended Use / Indications for Use
The Tenodesis Button is used for fixation of bone or soft tissue to bone, and is intended as fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications; anterior cruciate ligament, posterior cruciate ligament, pectoralis repair (minor/major), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Arthrex Tenodesis Button is made of titanium alloy. The proposed button is preloaded onto a driver/inserter, for single use. The holes in the button allow for the buttons to be threaded with Arthrex non-absorbable suture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee, shoulder, and elbow
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Tensile testing and cyclic loading was conducted to demonstrate that the proposed button performs similar to the predicate device.
Non-clinical testing per the FDA Guidance, "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment", demonstrated that the Arthrex buttons are "MR Conditional".
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.
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the agency's name, "U.S. Food & Drug Administration."
Arthrex Inc. Ivette Galmez Senior Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K190288
Trade/Device Name: Arthrex Tenodesis Button Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: August 9, 2019 Received: August 12, 2019
Dear Ivette Galmez:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurence D. Coyne, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Arthrex Tenodesis Button
Indications for Use (Describe)
The Tenodesis Button is used for fixation of bone or soft tissue to bone, and is intended as fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications; anterior cruciate ligament, posterior cruciate ligament, pectoralis repair (minor/major), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.
| 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) |
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3
510(k) Summary
K190288
| Date Prepared | March 26, 2019 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Ivette Galmez |
| Senior Regulatory Affairs Specialist | |
| 1-239-643-5553, ext. 71263 | |
| Ivette.galmez@arthrex.com | |
| Name of Device | Arthrex Tenodesis Button |
| Common Name | Fastener, fixation, nondegradable, soft tissue |
| Product Code | MBI |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| Regulatory Class | II |
| Predicate Device | K123341: Arthrex Pec Repair Button, Large Pec Button, Biceps Button and Proximal |
| Biceps Button | |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted to obtain clearance for the |
| Arthrex Tenodesis Button. This submission contains a modification to the device | |
| labeling to include the "MR Conditional" statement in accordance with the FDA | |
| Guidance, "Establishing Safety and Compatibility of Passive Implants in the Magnetic | |
| Resonance (MR) Environment". | |
| Device Description | The Arthrex Tenodesis Button is made of titanium alloy. The proposed button is |
| preloaded onto a driver/inserter, for single use. The holes in the button allow for the | |
| buttons to be threaded with Arthrex non-absorbable suture. | |
| Indications for Use | The Arthrex Tenodesis Button is used for fixation of bone to bone or soft tissue to |
| bone, and is intended as fixation post, a distribution bridge, or for distributing suture | |
| tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and | |
| may include the following indications; anterior cruciate ligament, posterior cruciate | |
| ligament, pectoralis repair (minor/major), biceps tendon repair and reattachment | |
| (distal/proximal), acromioclavicular repair, and ulnar collateral ligament | |
| reconstruction. | |
| Performance Data | Tensile testing and cyclic loading was conducted to demonstrate that the proposed |
| button performs similar to the predicate device. |
Non-clinical testing per the FDA Guidance, "Establishing Safety and Compatibility of
Passive Implants in the Magnetic Resonance (MR) Environment", demonstrated that
the Arthrex buttons are "MR Conditional".
Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the
device meets pyrogen limit specifications. |
| Conclusion | The Arthrex Tenodesis Button is substantially equivalent to the predicate device in
which the basic design features and intended uses are the same. Any differences
between the proposed device and the predicate device are considered minor and do
not raise questions concerning safety or effectiveness.
Based on the indications for use, technological characteristics, and the summary of
data submitted, Arthrex Inc. has determined that the proposed devices are
substantially equivalent to the currently marketed predicate device. |