Knotless TensionTight Button Implant System

K202444 · Arthrex, Inc. · MBI · Nov 17, 2020 · Orthopedic

Device Facts

• Record ID: K202444
• Device Name: Knotless TensionTight Button Implant System
• Applicant: Arthrex, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Nov 17, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Knotless TensionTight Button Implant System is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip the following procedures: · Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction · Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction · Hand Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty) • Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital tendon transfers, Mid-foot reconstruction · Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis · Hip: Acetabular Labral Repair

Device Story

System consists of titanium alloy button with locking trap door; preloaded on inserter with suture threader, nitinol loop, and two #5 FiberLink sutures. Used by surgeons in OR for soft tissue-to-bone fixation. Surgeon inserts button through bone; locking mechanism secures suture to maintain tension. Provides stable fixation for tendon/ligament repairs; facilitates healing by holding tissue in place during recovery.

Clinical Evidence

Bench testing only. Static and dynamic pull-out testing met criteria established by predicate K181769. Biocompatibility testing per ISO 10993-1:2009 passed. Bacterial endotoxin testing per EP 2.6.14 / USP <85> confirmed compliance with pyrogen limits.

Technological Characteristics

Titanium alloy (Ti-6Al-4V) per ASTM F2885; oblong button with trap door locking mechanism; includes nitinol loop and #5 FiberLink sutures. Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for fixation of soft tissue to bone in shoulder, foot/ankle, knee, hand/wrist, elbow, and hip procedures, including ligament reconstructions, tendon repairs, and arthroplasty, in patients requiring surgical soft tissue fixation.

Regulatory Classification

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.

Predicate Devices

• Arthrex FiberTak Suture Anchor (K181769)
• Arthrex Proximal Biceps Button (K123341)
• Arthrex PushLock Suture Anchor (K061863)

Reference Devices

• Arthrex #5 FiberLink sutures (K122374)

Submission Summary (Full Text)

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November 17, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Arthrex Inc. Jessica Singelais Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108

Re: K202444

Trade/Device Name: Knotless TensionTight Button Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: October 16, 2020 Received: October 20, 2020

Dear Ms. Singelais:

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 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

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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 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 ([e-mail]) or phone [phone] 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) K202444

#### Device Name

Knotless TensionTight Button Implant System

#### Indications for Use (Describe)

The Knotless TensionTight Button Implant System is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip the following procedures:

· Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

· Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

· Hand Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)

• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital tendon transfers, Mid-foot reconstruction

· Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis

· Hip: Acetabular Labral Repair

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial, sans-serif;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

| Date Prepared | October 16, 2020 |
|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Arthrex Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 |
| Contact Person | Jessica Singelais<br>Regulatory Affairs Specialist<br>1-239-598-4302, ext. 73091<br>[e-mail] |
| Name of Device | Knotless TensionTight Button Implant System |
| 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 | Class II |
| Predicate Device | K181769: Arthrex FiberTak Suture Anchor<br>K123341: Arthrex Proximal Biceps Button<br>K061863: Arthrex PushLock Suture Anchor |
| Purpose of Submission | This Special 510(k) premarket notification is submitted to obtain clearance for the<br>Knotless TensionTight Button Implant System. |
| Device Description | The Knotless TensionTight Button Implant System consists of an oblong Titanium alloy<br>button with locking trap door preloaded on an inserter with a suture threader and<br>nitinol loop and two Arthrex #5 FiberLink sutures (K122374). The button and sutures<br>are packaged with class I exempt instrumentation. |
| Indications for Use | The Knotless TensionTight Button Implant System is intended for fixation of suture<br>(soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip the<br>following procedures:<br>• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament<br>Reconstruction<br>• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps<br>Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or<br>Capsulolabral Reconstruction<br>• Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of<br>collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and<br>MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction<br>and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)<br>• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair,<br>Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital tendon<br>transfers, Mid-foot reconstruction<br>• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair,<br>Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band<br>Tenodesis<br>• Hip: Acetabular Labral Repair |
| Performance Data | Static and dynamic pull-out testing of the proposed Knotless TensionTight Button<br>Implant System met the criteria established by the predicate device (K181769).<br>Biocompatibility testing per ISO 10993-1:2009 demonstrated passing results.<br>Bacterial endotoxin per EP 2.6.14 / USP <85> was conducted to demonstrate that the<br>device meets pyrogen limit specifications |
| Comparison Summary<br>of Technological<br>Characteristics and<br>Modifications<br>Proposed | The proposed and predicate devices (K123341) have the same technological<br>characteristics (base material, sterilization, shelf life, and packaging). In comparison<br>to the predicate (K123341), the proposed device is manufactured from titanium alloy<br>Ti-6Al-4V per ASTM F2885 and features a trap door locking mechanism. The proposed<br>device has the same indications for use as the predicate device (K181769). Any<br>differences between the proposed device and the predicate devices are considered<br>minor and do not raise questions concerning safety or effectiveness |
| Conclusion | The Knotless TensionTight Button Implant System is substantially equivalent to the<br>predicate devices in which the basic design features, sterility, shelf life and packaging<br>configuration, and intended uses are the same.<br><br>Based on the indications for use, technological characteristics, and the summary of<br>data submitted, Arthrex Inc. has determined that the proposed device is substantially<br>equivalent to the currently marketed predicate devices. |

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