Arthrex DynaNite Compression Plate

K193345 · Arthrex, Inc. · HRS · Jul 8, 2020 · Orthopedic

Device Facts

• Record ID: K193345
• Device Name: Arthrex DynaNite Compression Plate
• Applicant: Arthrex, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Jul 8, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex DynaNite Compression Plate is intended to be used for fixation such as: LisFranc arthrodesis, mono or bicortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus. The Arthrex DynaNite Compression Plate is intended to be used in conjunction with the Arthrex Compression FT Screws.

Device Story

Arthrex DynaNite Compression Plate is a metallic bone fixation implant featuring threaded holes and central articulating arms; available in straight, T-shape, and X-shape configurations. Device is supplied pre-attached to a clamp delivery system that constrains the plate in an elongated state. During surgery, the surgeon secures the plate with screws; removal of the clamp allows the plate to utilize its shape-memory effect to shorten along its long axis, generating active compression across the bone site. Used in clinical settings by orthopedic surgeons for foot and ankle procedures. Benefits include active compression to facilitate bone healing and stabilization. Device is single-use and sterile.

Clinical Evidence

Bench testing only. Performed static and fatigue four-point bend testing (ASTM F382), compressive force, transformation temperature (ASTM F2082), and corrosion resistance (ASTM F2129). Conducted MRI safety testing (force, torque, artifacts, heating) per FDA guidance and ASTM standards (F2052, F2119, F2182, F2213). Biocompatibility testing performed per ISO 10993-1:2018, including cytotoxicity, sensitization, irritation, genotoxicity, and systemic toxicity. Bacterial endotoxins testing performed per ANSI/AAMI ST72, USP <161>, USP <85>, and EP 2.6.14.

Technological Characteristics

Metallic bone fixation plate utilizing shape-memory effect for compression. Configurations: straight, T-shape, X-shape. Sizes: 15-30mm hole-to-hole. Materials: Nitinol (implied by shape memory/DynaNite branding). Standards: ASTM F382 (bending), ASTM F2082 (transformation temperature), ASTM F2129 (corrosion), ASTM F2052/F2119/F2182/F2213 (MRI safety). Sterile, single-use. Used with Arthrex 3.0 mm Titanium VA Locking Screws and Compression FT Screws.

Indications for Use

Indicated for patients requiring bone fixation in the forefoot, midfoot, and hindfoot, including LisFranc arthrodesis, osteotomies (mono/bicortical, Akin, Scarf, Chevron), and arthrodesis (first metatarsophalangeal, metatarsocuneiform) for conditions such as hallux valgus and metatarsus primus varus.

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

• MXO dynaMX Compression Plate (K161303)
• Synthes (USA) 1.5mm Mini Fragment LCP System (K090047)

Reference Devices

• Arthrex DynaNite Nitinol Staple (K172052)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

July 8, 2020

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

Re: K193345

Trade/Device Name: Arthrex DynaNite Compression Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS. HWC Dated: June 3, 2020 Received: June 5, 2020

Dear Rebecca R. 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

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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 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 Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K193345

#### Device Name Arthrex DynaNite Compression Plate

#### Indications for Use (Describe)

The Arthrex DynaNite Compression Plate is intended to be used for fixation such as: LisFranc arthrodesis, mono or bicortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.

The Arthrex DynaNite Compression Plate is intended to be used in conjunction with the Arthrex Compression FT Screws.

| Type of Use (Select one or both, as applicable) |
|------------------------------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 10pt;"> <b> ☑ </b> </span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
| <span> <span style="font-size: 10pt;"> ☐ </span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 510(k) Summary

| Date Prepared | July 1, 2020 |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Arthrex Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 |
| Contact Person | Rebecca R. Homan<br>Regulatory Affairs Specialist<br>1-239-643-5553, ext. 73429<br>[e-mail] |
| Name of Device | Arthrex DynaNite Compression Plate |
| Common Name | plate, fixation, bone |
| Product Code | HRS |
| Classification Name | 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances<br>and accessories |
| Regulatory Class | II |
| Predicate Device | K161303: ΜΧO dynaMX Compression Plate (Primary Predicate)<br>K090047: Synthes (USA) 1.5mm Mini Fragment LCP System |
| Reference Device | K172052: Arthrex DynaNite Nitinol Staple |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for<br>the Arthrex DynaNite Compression Plate. |
| Device Description | The Arthrex DynaNite Compression Plate is an implant with a number of<br>threaded holes and a central region of articulating arms. Sizes range from<br>approximately 15 to 30mm in hole-to-hole distance. Geometrically, the plate is<br>offered in straight, 'T-shape', and 'X-shape' configurations. The Arthrex DynaNite<br>Compression Plate is sold attached to a clamp delivery device, which constrains<br>the implant in an elongated state, along its long axis. The clamp delivery device is<br>removed after screw fixation is achieved, which in turn causes the plate to return<br>to its original confirmation (shape memory effect), shortening along its long axis<br>and generating compression. The Arthrex DynaNite Compression Plate is sold as<br>sterile and is single-use. The Arthrex DynaNite Compression Plate is to be used<br>with the Arthrex 3.0 mm Titanium VA Locking Screws and Locking Screws cleared<br>under K143614 and K150456. |
| Indications for Use | The Arthrex DynaNite Compression Plate is indicated to be used for fixation such<br>as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first<br>metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot<br>arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment<br>(Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to<br>reposition and stabilize metatarsus primus varus.<br><br>The Arthrex DynaNite Compression Plate is intended to be used in conjunction<br>with the Arthrex Compression FT Screws. |
| Performance Data | Static Four-Point Bend (ASTM F382) and Four-Point Bend Fatigue (ASTM F382)<br>testing was conducted to demonstrate that the proposed Arthrex DynaNite<br>Compression Plate performs statistically equivalent to the predicate devices<br>cleared under K090047 and K172052. Compressive Force, Transformation<br>Temperature (ASTM F2082), Cyclic Potentiodynamic Polarization Corrosion<br>(ASTM F2129), and Galvanic Corrosion Resistance (ASTM F2129) testing was also<br>conducted.<br><br>MRI force, torque, and image artifact testing were conducted in accordance with |
| | 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. |
| | Bacterial Endotoxins Test (BET) was performed on the Arthrex DynaNite<br>Compression Plate utilizing the Kinetic Chromogenic Method in accordance with |
| | ANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14. The testing<br>conducted demonstrates that the Arthrex DynaNite Compression Plate meets<br>pyrogen limit specifications. |
| | Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity,<br>Subchronic/Subacute Toxicity, Implantation and Material Characterization testing<br>was conducted on the Arthrex DynaNite Compression Plate in accordance with<br>ISO 10993-1:2018. |
| | Assessment of physical product attributes including product, design, size, and<br>materials as well as the conditions of manufacture and packaging has determined<br>that the Arthrex DynaNite Compression Plate does not introduce additional risks<br>or concerns regarding sterilization and shelf-life. |
| Conclusion | The Arthrex DynaNite Compression Plate is substantially equivalent to the<br>predicate devices in which the basic design features and intended uses are the<br>same. Any differences between the proposed device and the predicate devices<br>are considered minor and do not raise different questions concerning safety or<br>effectiveness. |
| | The submitted mechanical testing data demonstrates that the Static Four-Point<br>Bend and Four-Point Bend Fatigue strength of the proposed device is<br>substantially equivalent to that of the predicate devices for the desired<br>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 devices. |

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