(66 days)
No
The summary describes a mechanical suture and button device for fracture repair and ligament fixation. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is intended to provide fixation during the healing process, acting as an adjunct in fracture repair, rather than directly treating a disease or condition to restore health.
No
The device is described as a "suture construct configured with one or two metal buttons" intended for "fixation during the healing process following syndesmotic trauma," indicating it is a surgical implant designed for repair, not diagnosis. The "Intended Use / Indications for Use" section further clarifies its role in fracture repair and fixation.
No
The device description clearly states the device is a suture construct with metal buttons, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used in vivo (within the body) for fracture repair and fixation of ligaments. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a physical implant (suture constructs with metal buttons) designed to be placed within the body.
- Performance Studies: The performance studies focus on mechanical strength, bacterial endotoxin levels, and MRI compatibility – all relevant to an implantable medical device, not an IVD.
Therefore, the Knotless AC Repair Devices are not IVD devices. They are surgical implants used for orthopedic repair.
N/A
Intended Use / Indications for Use
The Knotless AC Repair Devices are intended as adjuncts in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
The Knotless AC Repair Devices are intended to provide fixation during the healing process following syndesmotic trauma, such as fixation of acromioclavicular separation due to coracoclavicular ligament disruption.
The Knotless AC Repair Devices with distal clavicle plate button are intended for use with Arthrex clavicle plates for clavicle indications and may not be used alone.
Product codes (comma separated list FDA assigned to the subject device)
HTN
Device Description
The subject devices are suture constructs configured with one or two metal buttons made of titanium or stainless steel. The nonabsorbable suture is made of UHMWPE. Some of the subject devices are compatible with the Clavicle Fracture plates cleared under K112437.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
Fracture repair involving metaphyseal and periarticular small bone fragments; syndesmotic trauma, such as fixation of acromioclavicular separation due to coracoclavicular ligament disruption; clavicle indications.
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)
Ultimate load testing and cyclic displacement was performed on the subject device and compared to the predicate device to demonstrate that the modifications do not negatively impact mechanical strength.
Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications.
MRI force, torque, and image artifact testing were conducted in accordance with FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, ASTM F2052 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment, ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants, and ASTM F2182 Standard Test Method for Measurement of Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging.
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.
K112437, K143139, K123341, K202581, K112990
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached 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 letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
June 6, 2022
Arthrex Inc. Ivette Galmez Regulatory Affairs Principal Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K220947
Trade/Device Name: Arthrex Knotless AC Repair Devices Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HTN Dated: March 30, 2022 Received: April 4, 2022
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.
1
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 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 (QS) 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 medical devices and radiation-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.
Limin Sun, Ph.D. Acting Assistant Director DHT6A: Division of Joint Arthroplasty 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)
K220947
Device Name
Arthrex Knotless AC Repair Devices
Indications for Use (Describe)
The Knotless AC Repair Devices are intended as adjuncts in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
The Knotless AC Repair Devices are intended to provide fixation during the healing process following syndesmotic trauma, such as fixation of acromioclavicular separation due to coracoclavicular ligament disruption.
The Knotless AC Repair Devices with distal clavicle plate button are intended for use with Arthrex clavicle plates for clavicle indications and may not be used alone.
| 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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3
510(k) Summary
| Date Prepared | May 26, 2022 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Ivette Galmez |
| Regulatory Affairs Principal Specialist | |
| 1-239-643-5553, ext. 71263 | |
| Ivette.galmez@arthrex.com | |
| Name of Device | Arthrex Knotless AC Repair Devices |
| Common Name | Suture Button |
| Product Code | HTN |
| Classification Name | 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances and accessories |
| Regulatory Class | II |
| Predicate Device | K052776: Arthrex TightRope Acromioclavicular (AC) Device |
| Reference Device | K112437: Arthrex Fracture System |
| K143139: Arthrex Fracture System, Sterile | |
| K123341: Arthrex Pec Repair Button | |
| K202581: Arthrex TightRope II | |
| K112990: ACL TightRope | |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for the Arthrex |
| Knotless AC Repair Devices as a line extension to the Arthrex TightRope AC Device cleared | |
| under K052776. | |
| Device Description | The subject devices are suture constructs configured with one or two metal buttons made of |
| titanium or stainless steel. The nonabsorbable suture is made of UHMWPE. Some of the | |
| subject devices are compatible with the Clavicle Fracture plates cleared under K112437. | |
| Indications for Use | The Knotless AC Repair Devices are intended as adjuncts in fracture repair involving |
| metaphyseal and periarticular small bone fragments where screws are not indicated, and as | |
| adjuncts in external and intramedullary fixation systems involving plates and rods, with | |
| fracture braces and casting. | |
| The Knotless AC Repair Devices are intended to provide fixation during the healing process | |
| following syndesmotic trauma, such as fixation of acromioclavicular separation due to | |
| coracoclavicular ligament disruption. | |
| The Knotless AC Repair Devices with distal clavicle plate button are intended for use with | |
| Arthrex clavicle plates for clavicle indications and may not be used alone. | |
| Summary of | |
| Technological | |
| Characteristics | The proposed devices have similar technological characteristics as the predicate. The subject |
| devices are configured with two buttons and are made of the same materials as the | |
| predicate. Some models may include an attachable coracoid button. The subject devices are | |
| sold sterile for single use. | |
| Performance Data | Ultimate load testing and cyclic displacement was performed on the subject device and |
| compared to the predicate device to demonstrate that the modifications do not negatively | |
| impact mechanical strength. | |
| Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device | |
| meets pyrogen limit specifications. | |
| MRI force, torque, and image artifact testing were conducted in accordance with FDA | |
| guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) | |
| Environment, ASTM F2052 Standard Test Method for Measurement of Magnetically Induced | |
| Displacement Force on Medical Devices in the Magnetic Resonance Environment, ASTM | |
| F2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants, and | |
| ASTM F2182 Standard Test Method for Measurement of Measurement of Radio Frequency | |
| Induced Heating Near Passive Implants During Magnetic Resonance Imaging. |
4
| Conclusion | The Arthrex Knotless AC Repair Devices are substantially equivalent to the predicate in which
the basic design features and intended use are the same. Any differences between the
subject device and the predicate device are considered minor and do not raise questions
concerning safety and effectiveness. |
|------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Based on the indications for use, technological characteristics, and the summary of data
submitted, Arthrex Inc. has determined that the proposed device is substantially equivalent
to the currently marketed predicate device. |