DynaNail Mini

K182677 · MedShape, Inc. · HWC · Feb 14, 2019 · Orthopedic

Device Facts

• Record ID: K182677
• Device Name: DynaNail Mini
• Applicant: MedShape, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Feb 14, 2019
• 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, non-unions, and fusions of large bones in the foot and ankle.

Device Story

DynaNail Mini is a sterile, single-use orthopedic implant system for midfoot and hindfoot reconstruction. Device consists of a titanium outer body providing structural rigidity and an internal Nitinol element providing sustained post-operative compression across joints. Implanted via a deployment frame using titanium headless fixation screws. Used by orthopedic surgeons in clinical settings to stabilize bones during fusion or reconstruction. Benefits include mechanical stability and active compression to promote bone healing. System includes associated surgical instruments for implantation.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including mechanical performance testing (pull-out per ASTM F543), pyrogenicity testing per ANSI/AAMI ST72, and bacterial endotoxin testing (BET) per ANSI/AAMI ST-72:2011.

Technological Characteristics

Materials: Implant-grade titanium alloy and Nickel Titanium (Nitinol) alloy. Design: Intramedullary nail with internal compressive element and headless fixation screws. Connectivity: None. Sterilization: Sterile. Testing: Pull-out per ASTM F543; Pyrogenicity/BET per ANSI/AAMI ST72.

Indications for Use

Indicated for patients requiring fracture fixation, osteotomies, reconstruction, non-union repair, or fusion of large bones in the foot and ankle.

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

• Wright Medical, Salvation Beams and Bolts System (K140741)
• DynaNail Ankle Nail, Intramedullary Fixation Rod (K171376)
• DynaNail Ankle Nail, Intramedullary Fixation Rod (K101934)
• Synthes, 6.5mm Midfoot Fusion Bolt (K081071)

Submission Summary (Full Text)

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February 14, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Medshape, Inc. Akhilesh Gokhale Project Manager 1575 Northside Drive. Suite 440 Atlanta, Georgia 30318

## Re: K182677

Trade/Device Name: DynaNail™M Mini Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, JDS Dated: January 10, 2019 Received: January 11, 2019

### 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.

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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,

# Shumaya Ali -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) K182677

Device Name DynaNail Mini

Indications for Use (Describe)

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.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image shows the MedShape logo. The logo consists of a blue abstract shape on the left and the word "MEDSHAPE" in gray on the right. The abstract shape is a combination of a square and a circle. The word "MEDSHAPE" is written in a sans-serif font, and there is a trademark symbol after the word.

## 510(k) Summary

510(k) Number: K182677

Date Submitted: January 10, 2019

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 Manager, Research & Development [phone] (direct) [phone] (fax) [e-mail]

- C. Device Information:

| | Trade Name:<br>Common Name: | DynaNail™ Mini<br>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:<br>Product Code: | Class II, Panel Code: 87<br>HWC, Screw, Fixation Bone, 888.3040<br>JDS, Nail, Fixation, Bone, 888.3030 |

- E. Predicate Device(s):
Wright Medical, Salvation Beams and Bolts System, K140741 DynaNail™ Ankle Nail, Intramedullary Fixation Rod, K171376 DynaNail™ Ankle Nail, Intramedullary Fixation Rod, K101934 Synthes, 6.5mm Midfoot Fusion Bolt, K081071

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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.

#### F. Physical Description:

The proposed DynaNail™ Mini is a sterile, single use titanium device with an additional internal Nitinol compressive element for use in midfoot and hindfoot reconstruction. The DynaNail™ Mini's 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 is available in multiple diameters and lengths to accommodate variations in patient anatomy. The DynaNail™ Mini is implanted with a 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 is substantially equivalent in Intended Use, diameter and length to the following predicate devices:

Wright Medical, Salvation Beams and Bolts System, K140741

The DynaNail™ Mini is substantially equivalent in function, material and design to the following predicate devices:

DynaNail™ Ankle Nail, Intramedullary Fixation Rod, K171376 DynaNail™ Ankle Nail, Intramedullary Fixation Rod, K101934

The proposed and predicate devices are comprised of implant grade Titanium alloy and Nickel Titanium Alloy. All implants are sold sterile. Engineering analysis and mechanical performance testing (Pull-out per ASTM F543) was performed. The test results and analysis demonstrate substantial equivalent performance to the predicate devices.

The manufacture and processing of all patient contacting materials are identical to the predicate DynaNail™ K171376.

Image /page/4/Picture/14 description: The image shows the Medshape logo. The logo consists of a blue abstract shape on the left and the word "MEDSHAPE" in gray on the right. The abstract shape is made up of a square and a circle connected by a curved line.

1575 Northside Drive, Suite 440 Atlanta, GA 30318 404-249-9155 phone [phone] fax

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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.

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

Image /page/5/Picture/3 description: The image shows the Medshape logo. The logo consists of a blue abstract shape on the left and the word "MEDSHAPE" in gray on the right. The abstract shape appears to be a combination of a square and a circle. The word "MEDSHAPE" is written in a sans-serif font.

1575 Northside Drive, Suite 440 Atlanta, GA 30318 404-249-9155 phone [phone] fax