Arthrex Mini Hip PushLock

K201786 · Arthrex, Inc. · MAI · Jul 30, 2020 · Orthopedic

Device Facts

• Record ID: K201786
• Device Name: Arthrex Mini Hip PushLock
• Applicant: Arthrex, Inc.
• Product Code: MAI · Orthopedic
• Decision Date: Jul 30, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex Mini Hip PushLock is intended to be used for suture (soft tissue) to bone in the hip. Specifically, Acetabular Labral Repair.

Device Story

Barbed push-in suture anchor; pre-loaded on disposable inserter; used for soft tissue-to-bone fixation in hip (acetabular labral repair). Device manufactured from PLLA/β-TCP; sterile; single-use. Operated by surgeons in clinical/OR settings. Anchor inserted into bone to secure sutures; provides mechanical fixation for labral tissue. Benefits include stable tissue reattachment to bone during healing.

Clinical Evidence

Bench testing only. Pull-out testing performed after 26-week degradation period; met 20 lbf acceptance criterion. Bacterial endotoxin testing conducted per EP 2.6.14/USP <85> to meet pyrogen limits. Biocompatibility relied on reference device (K101679) data due to identical materials and processing.

Technological Characteristics

Material: PLLA/β-TCP. Design: Barbed push-in suture anchor. Delivery: Disposable inserter. Sterilization: Gamma radiation. Connectivity: None (mechanical device).

Indications for Use

Indicated for suture (soft tissue) to bone fixation in the hip, specifically for Acetabular Labral Repair.

Regulatory Classification

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.

Predicate Devices

• Arthrex Short Suture Anchors (K151092)

Reference Devices

• Arthrex PushLock (K101679)

Submission Summary (Full Text)

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July 30, 2020

Image /page/0/Picture/1 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 seal on the left and the FDA acronym and name on the right. The seal features an eagle with its wings spread, and the FDA part includes the acronym in a blue square and the full name "U.S. Food & Drug Administration" in blue text.

Arthrex Inc. Kelsey Roberts Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108

Re: K201786

Trade/Device Name: Arthrex Mini Hip PushLock Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: MAI, HWC Dated: June 25, 2020 Received: June 30, 2020

Dear Kelsey 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 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. Acting 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)

K201786

Device Name Arthrex Mini Hip PushLock

Indications for Use (Describe)

The Arthrex Mini Hip PushLock is intended to be used for suture (soft tissue) to bone in the hip. Specifically, Acetabular Labral Repair.

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

| <div style="display:inline-block"><span style="text-decoration:overline">[</span>X]</div> | Registration Use (Part 21 CFR 201.1 Subpart D) |
|-------------------------------------------------------------------------------------------|------------------------------------------------|
| <div><span>[ ]</span></div> | Over-The-Counter Use (21 CFR 201.1 Subpart C) |

> Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) Summary K201786

| Date Prepared | July 8, 2020 |
|--------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Arthrex Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 |
| Contact Person | Kelsey Roberts<br>Regulatory Affairs Associate<br>1-239-598-4302, ext. 72257<br>[e-mail] |
| Name of Device | Arthrex Mini Hip PushLock |
| Common Name | Smooth or threaded metallic bone fixation fastener |
| Product Code | MAI, HWC |
| Classification Name | 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances<br>accessories<br>21 CFR 888.3040: Smooth or threaded metallic bone fastener |
| Regulatory Class | II |
| Predicate Device | K151092: Arthrex Short Suture Anchors |
| Reference Device | K101679: Arthrex PushLock |
| Purpose of Submission | This Special 510(k) premarket notification is submitted to add the Arthrex 2.4 Mini<br>Hip PushLock as a line extension to the Arthrex Short Anchors cleared under<br>predicate K151092. |
| Device Description | The Arthrex Mini Hip PushLock is a barbed push-in suture anchor pre-loaded on a<br>disposable inserter. The anchor is manufactured from PLLA/ $\u03b2$ TCP and is offered<br>sterile, single use. |
| Indications for Use | The Arthrex Mini Hip PushLock Anchor is intended to be used for suture (soft tissue)<br>fixation to bone in the hip. Specifically, Acetabular Labral Repair. |
| Comparison Summary<br>of Technological<br>Characteristics and<br>Modifications<br>Proposed | The proposed and predicate devices (K151092) have the same intended use and basic<br>device design. The proposed device modifications consist of anchor material (PLLA/<br>$\u03b2$ TCP) and sterilization method (gamma). The anchor material, manufacturing<br>processes and sterilization method are the same as the reference device (K101679).<br><br>The Arthrex Mini Hip PushLock Anchor is substantially equivalent to the predicate<br>device in which the basic design features and intended uses are the same. Any<br>differences between the proposed device and the predicate device are considered<br>minor and do not raise different questions concerning safety or effectiveness. |
| Performance Data | Pull-out testing was conducted after a 26-week degradation time period and<br>compared to an acceptance criterion of 20 lbf, as established for acetabular labral<br>repair in the predicate submission, demonstrating that the proposed device is<br>substantially equivalent to the predicate device (K151092).<br><br>Biocompatibility testing was not conducted as the materials and processing of the<br>Arthrex Mini Hip PushLock is the same as that of the reference device (K101679).<br><br>Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate that the<br>device meets pyrogen limit specifications. |
| Conclusion | The proposed Arthrex Mini Hip PushLock Suture Anchor is substantially equivalent to<br>the predicate device in which the basic design features and intended uses are the<br>same. Any differences between the proposed device and the predicate device are<br>considered minor and do not raise different questions concerning safety or<br>effectiveness. |

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Based on the indications for use, technological characteristics, and the summary of data submitted, Arthrex Inc. has determined that the Arthrex Mini Hip PushLock is substantially equivalent to the currently marketed predicate device.