Arthrex Mini Comprehensive Fixation System - 1.0mm Screws

K193156 · Arthrex, Inc. · HWC · Feb 10, 2020 · Orthopedic

Device Facts

• Record ID: K193156
• Device Name: Arthrex Mini Comprehensive Fixation System - 1.0mm Screws
• Applicant: Arthrex, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Feb 10, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex Mini Comprehensive Fixation System (1.0 mm solid) are intended for use in selective trauma, reconstructive procedures, and general surgery of the hand and wrist.

Device Story

The Arthrex Mini Comprehensive Fixation System consists of 1.0mm diameter titanium bone screws; used for fixation in hand and wrist trauma or reconstructive surgery. Screws are headed, self-tapping, and fully threaded; available in lengths from 6mm to 14mm. Device is non-sterile and single-use; intended for surgical implantation by orthopedic surgeons. Output is mechanical fixation of bone fragments; clinical benefit is stabilization of fractures or osteotomies to facilitate healing. Device is MR Conditional.

Clinical Evidence

Bench testing only. Mechanical performance evaluated via pull-out and torque testing per ASTM F543. MR compatibility evaluated per ASTM F2052, F2119, F2182, and F2213.

Technological Characteristics

Material: Titanium. Design: 1.0mm diameter, headed, self-tapping, fully threaded, solid bone screws. Dimensions: 6mm to 14mm length (1mm increments). Standards: ASTM F543 (mechanical), ASTM F2052, F2119, F2182, F2213 (MR safety). Sterilization: Non-sterile (user-sterilized).

Indications for Use

Indicated for selective trauma, reconstructive procedures, and general surgery of the hand and wrist.

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

• Synthes Stainless Steel Modular Hand System (K030310)

Reference Devices

• Arthrex Mini Comprehensive Fixation System - 1.4mm & 1.6mm Module (K191326)
• Arthrex Mini Comprehensive Fixation System - 2.0mm & 2.4mm Module (K191344)
• Synthes 1.0mm Ti. Cortex, Self-drilling Screws (hand & Neuro) (K050607)

Submission Summary (Full Text)

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February 10, 2020

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. The FDA logo is on the right, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are placed side by side.

Arthrex Inc. Rebecca R. Homan Senior Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K193156

Trade/Device Name: Arthrex Mini Comprehensive Fixation System - 1.0mm Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: November 11, 2019 Received: November 14, 2019

Dear Rebecca 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. 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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K193156

## Device Name

Arthrex Mini Comprehensive Fixation System - 1.0 mm Screws

Indications for Use (Describe)

The Arthrex Mini Comprehensive Fixation System (1.0 mm solid) are intended for use in selective trauma, reconstructive procedures, and general surgery of the hand and wrist.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## 510(k) Summary

| Date Prepared | February 7, 2020 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Arthrex Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 |
| Contact Person | Rebecca R. Homan<br>Senior Regulatory Affairs Associate<br>1-239-643-5553, ext. 73429<br>[e-mail] |
| Name of Device | Arthrex Mini Comprehensive Fixation System – 1.0mm Screws |
| Common Name | Screw, fixation, bone |
| Product Code | HWC |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| Regulatory Class | II |
| Predicate Device | K030310: Synthes Stainless Steel Modular Hand System |
| Reference Devices | K191326: Arthrex Mini Comprehensive Fixation System - 1.4mm & 1.6mm Module<br>K191344: Arthrex Mini Comprehensive Fixation System - 2.0mm & 2.4mm Module<br>K050607: Synthes 1.0mm Ti. Cortex, Self-drilling Screws (hand & Neuro) |
| Purpose of<br>Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for<br>the Arthrex Mini Comprehensive Fixation System – 1.0mm Screws. |
| Device Description | The Arthrex Mini Comprehensive Fixation System - 1.0mm Screws are<br>manufactured from titanium. The screws are headed and self-tapping. The<br>screws are available as fully threaded, solid screws. The screws are 1.0mm in<br>diameter and from 6 mm to 14 mm in length (in 1 mm increments). The screws<br>are sold non-sterile and single-use. |
| Indications for Use | The Arthrex Mini Comprehensive Fixation System Screws (1.0mm solid) are<br>intended for use in selective trauma, reconstructive procedures, and general<br>surgery of the hand and wrist. |
| Performance Data | Pull-out and torque testing was conducted in accordance with ASTM F543 to<br>demonstrate that the proposed Arthrex Mini Comprehensive Fixation System –<br>1.0mm Screws perform statistically equivalent to the predicate device, K030310.<br>Arthrex performed an engineering analysis to conclude that the Insertion<br>Torque/Failure Torque values of the Arthrex Mini Comprehensive Fixation System<br>– 1.0mm Screws were acceptable.<br><br>MRI force, torque, and image artifact testing were conducted in accordance with<br>FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic<br>Resonance (MR) Environment, ASTM F2052 Standard Test Method for<br>Measurement of Magnetically Induced Displacement Force on Medical Devices in<br>the Magnetic Resonance Environment, ASTM F2119 Standard Test Method for<br>Evaluation of MR Image Artifacts from Passive Implants, ASTM F2182 Standard<br>Test Method for Measurement of Measurement of Radio Frequency Induced<br>Heating Near Passive Implants During Magnetic Resonance Imaging and ASTM<br>F2213 Standard Test Method for Measurement of Magnetically Induced Torque<br>on Medical Devices in the Magnetic Resonance Environment. |
| Technological<br>Comparison | The Arthrex Mini Comprehensive Fixation System - 1.0mm Screws are<br>substantially equivalent to the predicate devices in which the basic design<br>features, fundamental scientific technology, intended use, indications for use. |
| | The Arthrex Mini Comprehensive Fixation System – 1.0mm Screws are<br>manufactured from titanium; whereas the predicate device, K030310 is<br>manufactured from stainless steel. However, the titanium alloy used to<br>manufacture the Arthrex Mini Comprehensive Fixation System - 1.0mm Screws is<br>identical is identical to the titanium alloy cleared in K191326 and K191344. |
| | The Arthrex Mini Comprehensive Fixation System – 1.0mm Screws were<br>evaluated for MR Conditional labeling; whereas the predicate device was not<br>evaluated for MR Conditional labeling. |
| Conclusion | The Arthrex Mini Comprehensive Fixation System – 1.0mm Screws are<br>substantially equivalent to the predicate devices in which the basic design<br>features and intended uses are the same. Any differences between the proposed<br>device and the predicate device are considered minor and do not raise different<br>questions concerning safety or effectiveness. |
| | The Arthrex Mini Comprehensive Fixation System – 1.0mm Screws MR<br>compatibility testing supports the devices MR Conditional labeling. There is no<br>increased risk from this difference in technology. |
| | The submitted mechanical testing data demonstrates that the pull-out and<br>torque strength of the proposed devices are substantially equivalent to that of<br>the predicate device for the desired indications. |
| | Based on the indications for use, technological characteristics, and the summary<br>of data submitted, Arthrex Inc. has determined that the proposed device is<br>substantially equivalent to the currently marketed predicate device. |

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