(57 days)
Not Found
No
The summary describes a mechanical suture and button construct for ACL/PCL repair and reconstruction. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies focus on mechanical strength, biocompatibility, and MRI compatibility.
Yes
The device is described as being used for "fixation of bone or soft tissue to bone" and specifically for "ACL/PCL Repair and Reconstruction," which are therapeutic interventions.
No
The device description states it is a "suture and button construct" intended for "ACL/PCL repair and reconstruction," indicating it is a therapeutic or reconstructive device, not a diagnostic one.
No
The device description clearly states it is a "suture and button construct comprised of a titanium button and nonabsorable suture," indicating it is a physical medical device, not software.
Based on the provided information, the Arthrex TightRope II is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the fixation of bone or soft tissue to bone, specifically for ACL/PCL repair and reconstruction. This is a surgical procedure performed in vivo (within the living body).
- Device Description: The device is a suture and button construct used for mechanical fixation within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Arthrex TightRope II does not perform any such function.
The information provided clearly describes a surgical implant used for structural support and fixation within the body, which falls under the category of a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
The Arthrex TightRope II is intended to be used for fixation of bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering these for ACL/PCL Repair and Reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
MBI, HTN
Device Description
The Arthrex TightRope II is suture and button construct comprised of a titanium button and nonabsorable suture intended to be used for the purpose ACL/PCL repair and reconstruction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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, ASTM F2182 Standard Test Method for Measurement of Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging and ASTM F2213 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment.
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 4, 2020
Kelsey Roberts Regulatory Affairs Associate Specialist Arthrex Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K202581
Trade/Device Name: Arthrex TightRope II Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI, HTN Dated: September 3, 2020 Received: September 8, 2020
Dear Ms. Roberts:
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
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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,
Laura C. Rose, 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
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Indications for Use
510(k) Number (if known) K202581
Device Name Arthrex TightRope II
Indications for Use (Describe)
The Arthrex TightRope II is intended to be used for fixation of bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering these for ACL/PCL Repair and 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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510(k) Summary
| Date Prepared | November 3, 2020 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Kelsey N. Roberts |
| Regulatory Affairs Associate Specialist | |
| 1-239-643-5553, ext. 72257 | |
| Kelsey.Roberts@arthrex.com | |
| Name of Device | Arthrex TightRope II |
| Common Name | Smooth or threaded metallic bone fixation fastener |
| Product Code | MBI - Smooth or threaded metallic bone fixation fastener. |
| HTN – Single/multiple component metallic bone fixation appliances and accessories | |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| Regulatory Class | II |
| Predicate Device | K112990: ACL TightRope and ACL TightRope Double Bundle |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for the |
| Arthrex TightRope II as a line extension to the Arthrex TightRope devices cleared | |
| under K112990. | |
| Device Description | The Arthrex TightRope II is suture and button construct comprised of a titanium |
| button and nonabsorable suture intended to be used for the purpose ACL/PCL repair | |
| and reconstruction. | |
| Indications for Use | The Arthrex TightRope II is to be 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. Specifically, Arthrex will be | |
| offering these for ACL/PCL repair and reconstruction. | |
| Comparison Summary | |
| of Technological | |
| Characteristic and | |
| Modifications | |
| Proposed | The proposed and predicate devices (K112990) have the same intended use and basic |
| device design features. The proposed device modifications consist of button design, | |
| button manufacturing, implantable suture design, and the addition of MR conditional | |
| labeling. The sterilization method, packaging, and button size is identical to the | |
| predicate (K112990). |
The Arthrex TightRope II 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
different questions concerning safety or effectiveness. |
| 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, ASTM F2182 Standard Test Method for
Measurement of Measurement of Radio Frequency Induced Heating Near Passive
Implants During Magnetic Resonance Imaging and ASTM F2213 Standard Test |
| | Method for Measurement of Magnetically Induced Torque on Medical Devices in the
Magnetic Resonance Environment. |
| Conclusion | The Arthrex TightRope II is substantially equivalent to the predicate device in which
the basic design features and intended use are the same. Any differences between
the Arthrex proposed 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. |
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