The dynaMX™ Nitinol Compression Screw is indicated for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies. Examples include, but are not limited to scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid. The implants are intended for single use only.

Device Description

The dynaMX™ Nitinol Compression Screw is a cannulated self-drilling / self-tapping screw with a threaded head which can be countersunk into the bone. The screw is available in a range of lengths from 16mm to 40mm in 2mm increments. The screw is manufactured from biocompatible superelastic Nitinol is fully transformed at room temperature and requires no external heating. Screws are shipped pre-elongated (i.e., stretched). An internal retaining pin maintains the screw in the stretched condition. Following implantation of the screw, removal of the internal retaining pin causes the screw to want shorten to its original un-stretched length. This action generates compression across the fracture site.

AI/ML Overview

This document describes a 510(k) premarket notification for the dynaMX™ Nitinol Compression Screw. The submission aims to demonstrate substantial equivalence to a predicate device, the Synthes (USA) 3.0mm Headless Compression Screw [K050636].

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists the following laboratory studies (bench tests) conducted to verify the suitability of the dynaMX™ Nitinol Compression Screw and establish substantial equivalence. While specific numerical acceptance criteria are not explicitly stated in this summary, the tests themselves represent the criteria used for evaluation. The "reported device performance" is implied to have met these criteria, leading to the conclusion of substantial equivalence.

Acceptance Criteria (Test Performed)	Reported Device Performance (Implied)
Torsional (Failure) Properties	Suitability for intended use, substantial equivalence to predicate.
Driving Torque Properties	Suitability for intended use, substantial equivalence to predicate.
Axial Pullout Strength	Suitability for intended use, substantial equivalence to predicate.
Compression Force Properties	Suitability for intended use, substantial equivalence to predicate (specifically related to its unique nitinol compression mechanism).
Transformation Temperature Determination	Confirmation of the superelastic Nitinol's properties and full transformation at room temperature.
Corrosion Testing	Biocompatibility and safety of the material.
Package Seal Strength Verification	Reproducibility of packaging and maintenance of sterility.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each specific bench test. It generally refers to "a series of laboratory studies (bench tests)". The data provenance is from bench testing, meaning it's in-vitro/ex-vivo laboratory data, not human patient data. There is no information regarding country of origin, retrospective or prospective nature, as it pertains to laboratory testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the studies are bench tests, not clinical studies requiring expert ground truth for patient outcomes. The "ground truth" for these tests would be established through engineering specifications, material science principles, and relevant industry standards.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are bench tests and do not involve human interpretation or adjudication in the context of clinical outcomes. The results of the bench tests would be measured and analyzed objectively against pre-defined specifications or predicate device performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. The device is a physical medical device (compression screw), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is a physical medical device and does not involve any algorithm or AI component that would be evaluated in a standalone manner.

7. The Type of Ground Truth Used

The ground truth for the bench tests would be based on:

Engineering Specifications: Pre-defined mechanical and material properties (e.g., strength, torque values, compression force).
Material Science Principles: Properties of Nitinol (e.g., transformation temperature).
Industry Standards: Relevant ASTM or ISO standards for testing medical devices and bone fixation fasteners.
Predicate Device Performance: Comparative data derived from the Synthes (USA) 3.0mm Headless Compression Screw, which serves as the established "truth" for substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The design, manufacturing, and testing processes are based on engineering principles and established medical device development guidelines.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol representing the human form, depicted as three stylized profiles facing to the right. The profiles are connected and flow together, creating a sense of unity and collaboration.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 2, 2016

MX Orthopedics Corporation Howard Schraver Official Correspondent 1050 Waltham Street, Suite 510 Lexington, Massachusetts 02421

Re: K160427

Trade/Device Name: dynaMX™ Nitinol Compression Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: April 29, 2016 Received: May 2, 2016

Dear Mr. Schrayer:

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. 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES	Form Approved: OMB No. 0910-0120
Food and Drug Administration	Expiration Date: January 31, 2017See PRA Statement below.
Indications for Use
510(k) Number (if known)	K160427
Device Name	dynaMX™ Nitinol Compression Screw
Indications for Use (Describe)	The dynaMX™ Nitinol Compression Screw is indicated for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies. Examples include, but are not limited to scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid. The implants are intended for single use only.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug AdministrationOffice of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) SUMMARY (Per 21 CFR 807.92)

General Company Information

MX Orthopedics, Corp. Name: Contact: Howard Schrayer Regulatory Affairs Consultant Address: 1050 Waltham St. Suite 510 Lexington, MA 02421 Telephone: (978) 294 - 8114 (978) 232 – 9998 Fax: Date Prepared May 31, 2016 General Device Information dynaMÄ™ Nitinol Compression Screw Product Name:
"Smooth or Threaded Metallic Bone Fixation Fastener" Classification: Product code: HWC - Class II 21 CFR 888.3040

Predicate Device

Synthes (USA) 3.0mm Headless Compression Screw [510(k) Number K050636]

Description

Screws are shipped pre-elongated (i.e., stretched). An internal retaining pin maintains the screw in the stretched condition. Following implantation of the screw, removal of the internal retaining pin causes the screw to want shorten to its original un-stretched length. This action generates compression across the fracture site.

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Indications for Use

The dynaMX™ Nitinol Compression Screw is indicated for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies. Examples include, but are not limited to scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid. The implants are intended for single use only.

Substantial Equivalence

A series of laboratory studies (bench tests) have been conducted to verify the suitability of the dynaMX™ Nitinol Compression Screw for its intended use, establish Substantial Equivalence with the predicate devices and confirm reproducibility of the packaging.

These tests include:

Torsional (Failure) Properties .
Driving Torque Properties .
Axial Pullout Strength ●
Compression Force Properties ●
Transformation Temperature Determination ●
Corrosion Testing ●
Package Seal Strength Verification

The dynaMÄ™ Nitinol Compression Screw is technologically similar to the primary predicate based on the following characteristics.

Threaded head which can be countersunk into the bone ●
Available in lengths of 16 to 40mm in 2mm increments ●
Cannulated for use with K-Wire .
Self-drilling and self-tapping ●
Distal screw thread length is 40% of total screw length ●
. Polished and chemically passivated

The dynaMX™ Nitinol Compression Screw is fabricated from biocompatible nitinol and the primary predicate is fabricated from stainless steel. The dynaMX™ Nitinol Compression Screw is provided sterile by gamma irradiation and the primary predicate is provided non-sterile.

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Conclusions

MÄ Orthopedics, Corp. believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as the MX Orthopedics dynaMÄ™ Nitinol Compression Screw. The materials from which the MX Orthopedics device is fabricated have an established history of use, and the devices have been tested in accordance with applicable FDA guidelines.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
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.(b)
Classification. Class II.