Arthrex NanoSuture Anchor

K180118 · Arthrex, Inc. · MBI · Feb 12, 2018 · Orthopedic

Device Facts

• Record ID: K180118
• Device Name: Arthrex NanoSuture Anchor
• Applicant: Arthrex, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Feb 12, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex NanoSuture Anchor is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications are listed below: 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, Repair/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 Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Device Story

Fully threaded titanium suture anchor; pre-loaded with suture on disposable inserter; 1.7 mm diameter, 5 mm length. Used by surgeons in clinical settings for soft tissue-to-bone fixation. Device provides mechanical anchor point for sutures to reattach tendons or ligaments to bone. Benefits include secure fixation during orthopedic repair procedures.

Clinical Evidence

Bench testing only. Pullout testing demonstrated statistical equivalence to predicate. Bacterial endotoxin testing per EP 2.6.14/USP <85> confirmed compliance with pyrogen limit specifications.

Technological Characteristics

Material: Titanium. Dimensions: 1.7 mm diameter, 5 mm length. Design: Fully threaded suture anchor. Delivery: Disposable inserter. Sterilization: Not specified.

Indications for Use

Indicated for suture or tissue fixation in foot/ankle, knee, hand/wrist, elbow, and shoulder for patients requiring ligament/tendon repair or reconstruction.

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 MicroSuture Anchors (K112237)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo, which features a stylized depiction of a human figure. The logo on the right is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name of the agency written in blue text to the right of the square.

February 12, 2018

Arthrex Inc. Rebecca R. Homan Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108

Re: K180118

Trade/Device Name: Arthrex NanoSuture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: January 11, 2018 Received: January 16, 2018

Dear Ms. Homan:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Katherine D. Kavlock -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known)

K180118

#### Device Name Arthrex NanoSuture Anchor

Indications for Use (Describe)

The Arthrex NanoSuture Anchor is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications are listed below:

| 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, Repair/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 Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis |

Type of Use (Select one or both, as applicable)

| <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|----------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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## 510(k) Summary or 510(k) Statement

| Date Prepared | February 8, 2018 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Arthrex Inc. |
| | 1370 Creekside Boulevard |
| | Naples, FL 34108-1945 |
| Contact Person | Rebecca R. Homan |
| | Regulatory Affairs Associate |
| | 1-239-643-5553, ext. 73429 |
| | [e-mail] |
| Name of Device | Arthrex NanoSuture Anchor |
| Common Name | Screw, fixation, bone |
| Product Code | MBI |
| Classification Name | 21 CFR 888.3040: Fastener, Fixation, Nondegradable, Soft Tissue |
| Regulatory Class | II |
| Predicate Device | K112237: Arthrex MicroSuture Anchors |
| Purpose of<br>Submission | This Special 510(k) premarket notification is submitted to obtain clearance for a<br>line extension to the Arthrex MicroSuture Anchors family cleared under K112237. |
| Device Description | The Arthrex NanoSuture Anchor is a fully threaded suture anchor pre-loaded with<br>Arthrex suture on a disposable inserter. The anchor is manufactured from<br>titanium and measures 1.7 mm in diameter and 5 mm in length. |
| Indications for Use | The Arthrex NanoSuture Anchor is intended to be used for suture or tissue<br>fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific<br>indications are listed below:<br><br>Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral<br>Ligament Reconstruction<br><br>Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps<br>Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair,<br>Capsular Shift or Capsulolabral Reconstruction<br><br>Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction<br>of collateral ligaments, Repair of Flexor and Extensor Tendons at<br>the PIP, DIP and MCP joints for all digits, digital tendon<br>transfers, Carpal Ligament Reconstruction and Carpometacarpal<br>joint arthroplasty (basal thumb joint arthroplasty)<br><br>Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon<br>Repair, Metatarsal Ligament Repair, Hallux Valgus<br>reconstruction, digital tendon transfers, Mid-foot reconstruction<br><br>Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament<br>Repair, Patellar Tendon Repair, Posterior Oblique Ligament<br>Repair, Iliotibial Band Tenodesis |
| Performance Data | Pullout testing was conducted to demonstrate that the proposed Arthrex<br>NanoSuture Anchor perform statistically equivalent to the predicate.<br><br>Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate that<br>the device meets pyrogen limit specifications. |
| Conclusion | The Arthrex NanoSuture Anchor is substantially equivalent to the predicate |
| 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 device is substantially equivalent to the currently marketed predicate device. | |

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