(51 days)
Not Found
No
The device description and performance studies focus on mechanical properties and fixation, with no mention of AI or ML.
No
This device is described as an implantable "suture button" used for fixation of bone to bone or soft tissue to bone, primarily as a mechanical aid in ligament and tendon repairs. It does not perform any therapeutic function itself, rather it facilitates the repair process.
No
The device is described as an implant used for fixation of bone to bone or soft tissue to bone, serving as fixation posts or for distributing suture tension during repair procedures. It does not perform any diagnostic function.
No
The device description clearly states the device is a physical, titanium oblong button used for surgical fixation, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The description clearly states that the Arthrex Pec Repair Button and related devices are used for fixation of bone to bone or soft tissue to bone and are intended as fixation posts, a distribution bridge, or for distributing suture tension during surgical repairs in the knee, shoulder, and elbow. This is a surgical implant/device used within the body during a procedure.
The device's function is mechanical support and fixation during surgery, not diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The Arthrex Pec Repair Button, Large Pec Button, Biceps Button, and Proximal Biceps Button are used for fixation of bone to bone or soft tissue to bone, and are intended as fixation posts, 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
MBI
Device Description
The four proposed Arthrex suture buttons are titanium oblong buttons that consist of two eyelets each that allow the buttons to be threaded with a variety of suture options. The Arthrex Pec Button, Large Pec Button, Biceps Repair Button and Proximal Biceps Buttons are used for fixation of bone to bone or soft tissue to bone, and are intended as fixation posts, 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.
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
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)
Results of mechanical testing which included tensile strength, demonstrated that the proposed products met the acceptance criteria for the proposed indications.
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
§ 888.3040 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.
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DEC 2 1 2012
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510(k) Summary of Safety and Effectiveness
| Date Summary Prepared | October 26, 2012 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Christina Flores |
| Regulatory Affairs Specialist | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext. 1819 | |
| Fax: 239/598.5508 | |
| Email: Christina.flores@arthrex.com | |
| Trade Name | Arthrex Pec Repair Button |
| Arthrex Large Pec Button | |
| Arthrex Biceps Button | |
| Arthrex Proximal Biceps Button | |
| Common Name | fastener, fixation, nondegradable, soft tissue |
| Product Code -Classification | |
| Name | |
| CFR | 21 CFR 888.3040: Smooth or threaded metallic bone |
| fixation fastener | |
| MBI - fastener, fixation, nondegradable, soft tissue | |
| Predicate Device | K031666 - Arthrex FiberWire® Button Repair Kit |
| K062747 - Arthrex RetroButton | |
| K083070 - Biomet ToggleLoc® System | |
| Purpose of Submission | This Traditional 510(k) premarket notification is |
| submitted to obtain clearance for the Arthrex Pec Repair | |
| Button, Large Pec Button, Biceps Button and Proximal | |
| Biceps Button to expand the Arthrex Suture Button | |
| product offering. No prior submissions have been | |
| submitted for the subject devices. | |
| Device Description and Intended | |
| Use | The four proposed Arthrex suture buttons are titanium |
| oblong buttons that consist of two eyelets each that allow | |
| the buttons to be threaded with a variety of suture options. | |
| The Arthrex Pec Button, Large Pec Button, Biceps | |
| Repair Button and Proximal Biceps Buttons are used for | |
| fixation of bone to bone or soft tissue to bone, and are | |
| intended as fixation posts, 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. | |
| Substantial Equivalence | |
| Summary | The proposed Arthrex Pec Button, Large Pec Button, |
| Biceps Repair Button and Proximal Biceps Button are | |
| substantially equivalent to the predicate devices, in which | |
| the basic features and intended uses are the same. Cortical | |
| button fixation using a variety of button configurations and | |
| suture combinations has been shown to be a | |
| biomechanically strong method of treating various tendon | |
| and ligament injuries. The addition of Pectoralis repair | |
| (minor/major) to the indications of the proposed devices do | |
| not raise new questions of safety or effectiveness as the | |
| fixation properties of the proposed devices meet or exceed | |
| the ultimate load to failure seen clinically for this type of | |
| repair. Any other differences between the Arthrex | |
| proposed devices and the predicates are considered minor | |
| and do not raise questions concerning safety and | |
| effectiveness. | |
| .Results of mechanical testing which included tensile | |
| strength, demonstrated that the proposed products met the | |
| acceptance criteria for the proposed indications. |
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Comments of the comments of
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the HHS logo, which is a stylized human figure embracing the world. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the logo.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 21, 2012
Arthrex, Incorporated % Ms. Christina Flores Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108
Re: K123341
Trade/Device Name: Arthrex Pec Repair Button, Large Pec Button, Biceps Button and Proximal Biceps Button
Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: October 26, 2012 Received: October 31, 2012
Dear Ms. Flores:
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
3
Page 2 - Ms. Christina Flores
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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.
Peter D. Rumm -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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1 Indications for Use Form
Indications for Use
K123341 510(k) Number:
Device Name: Arthrex Pec Repair Button, Large Pec Button, Biceps Button, and Proximal Biceps Button
Indications for Use:
The Arthrex Pec Repair Button, Large Pec Button, Biceps Button, and Proximal Biceps Button are used for fixation of bone to bone or soft tissue to bone, and are intended as fixation posts, 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.
Prescription Use _ X_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)
Casey Hanley
For Division of Orthopaedic Devices