Dynanail Mini Hybrid

K203381 · MedShape, Inc. · HWC · Jan 15, 2021 · Orthopedic

Device Facts

• Record ID: K203381
• Device Name: Dynanail Mini Hybrid
• Applicant: MedShape, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Jan 15, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DynaNail Mini™ Fusion System is indicated for fracture fixation, osteotomies, reconstruction procedures, nonunions, and fusions of large bones in the foot and ankle.

Device Story

DynaNail Mini Hybrid™ is a sterile, single-use orthopedic implant system for midfoot and hindfoot reconstruction. It consists of a titanium outer body providing bending and torsional rigidity and an internal Nitinol compressive element that sustains compression across joints post-operatively. The device is implanted by a surgeon using a driver/deployment frame and titanium headless fixation screws. By maintaining active compression across the fusion site, the device aims to improve fusion outcomes in bone reconstruction procedures. It is available in various diameters and lengths to accommodate patient anatomy.

Clinical Evidence

Bench testing only. Performance testing included static torsion (ASTM F543), static axial strain (ASTM F2516), and fatigue strain (ASTM E606). Pyrogenicity and bacterial endotoxin testing were conducted per ANSI/AAMI ST72:2011 (R2016).

Technological Characteristics

Materials: Titanium alloy and Nickel Titanium (Nitinol) alloy. Design: Metallic bone fixation fastener with internal compressive element. Sterilization: Sterile, single-use. Testing standards: ASTM F543, ASTM F2516, ASTM E606, ANSI/AAMI ST72.

Indications for Use

Indicated for fracture fixation, osteotomies, reconstruction procedures, nonunions, and fusions of large bones in the foot and ankle for patients requiring midfoot and hindfoot 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

• DynaNail Mini™ (K182677)

Submission Summary (Full Text)

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January 15, 2021

MedShape Inc Akhilesh Gokhale Product Manager 1575 Northside Drive. Suite 440 Atlanta, Georgia 30318

Re: K203381

Trade/Device Name: DynaNail Mini HybridTM Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, JDS Dated: October 21, 2020 Received: November 17, 2020

Dear Akhilesh Gokhale:

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.

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542 of the Act); 21 CFR 1000-1050.

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 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-

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, M.P.H. 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) K203381

Device Name DynaNail Mini Hybrid™

Indications for Use (Describe)

The DynaNail Mini™ Fusion System is indicated for fracture fixation, osteotomies, reconstruction procedures, nonunions, and fusions of large bones in the foot and ankle.

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

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

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# 510(k) Summary

510(k) Number: K203381

Date Submitted: October 21, 2020

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

- A. Submitter:
MedShape, Inc. 1575 Northside Drive, Suite 440 Atlanta, Georgia 30318

- B. Company Contact:
Akhilesh Gokhale Product Manager, Research & Development [phone] (direct) [phone] (fax) [e-mail]

- C. Device Information:

| | Trade Name: | DynaNail Mini Hybrid ™ |
|----|----------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| | Common Name: | Smooth or threaded metallic bone fixation fastener<br>Orthopedic Nail |
| D. | Classification Name: | Smooth or threaded metallic bone fixation fastener<br>Single/multiple component metallic bone fixation appliances<br>and accessories |
| | Regulatory Class: | Class II, Panel Code: 87 |
| | Product Code: | HWC, Screw, Fixation Bone, 888.3040<br>JDS, Nail, Fixation, Bone, 888.3030 |

- E. Predicate Device(s):
DynaNail Mini™, Orthopedic Nail, K182677

This statement is based on the similarity of the subject device to the predicate devices in one or more of intended use, materials, design and principles of operation.

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#### F. Physical Description:

The proposed DynaNail Mini Hybrid™ is part of the DynaNail Mini™ Fusion System. The proposed implant is sterile, single use titanium device with an additional internal Nitinol compressive element for use in midfoot and hindfoot reconstruction. A titanium outer body provides bending and torsional rigidity to the arthrodesis construct, while the internal Nitinol compressive element sustains compression across the joints post-operatively.

The DynaNail Mini Hybrid™ is available in multiple diameters and lengths to accommodate variations in patient anatomy. The DynaNail Mini Hybrid™ is implanted with a driver/ deployment frame and fixation screws. The fixation screws are single use titanium headless screws. These are available in various lengths to accommodate the anatomical fixation required. The system includes instruments for implantation.

#### G. Indications for Use:

The DynaNail Mini™ Fusion System is indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of large bones in the foot and ankle.

#### H. Comparison of Technological Characteristics:

The DynaNail Mini Hybrid™ is substantially equivalent in Intended Use, design, function, material, diameter and length to the following predicate devices:

## DynaNail Mini™, Orthopedic Nail, K182677

The proposed and predicate devices are comprised of implant grade Titanium alloy and Nickel Titanium Alloy. All implants are sold sterile. In addition to engineering analysis, the device was subjected to following performance tests to support the assertion of substantial equivalence:

- Static Torsion test per ASTM F543
- Static Axial Strain test per ASTM F2516
- Fatigue Strain test per ASTM E606

The test results and analysis demonstrate substantial equivalent performance to the predicate device.

The manufacture and processing of all patient contacting materials are identical to the predicate DynaNail Mini™ K182677.

Pyrogenicity testing was conducted per ANSI/AAMI ST72 for the worst case largest DynaNail™ system, confirming the most loaded device scenario meets the limit of 20EU. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011 (R2016).

Analysis substantiates the statement that the proposed device performs equivalently to the predicate device.