(108 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and function of a physical screw made of Nitinol, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for fixation of fractures and non-unions, arthrodesis, bunionectomies, and osteotomies, which are therapeutic interventions.
No
Explanation: The device is a surgical implant designed for fixation of fractures and non-unions, arthrodesis, bunionectomies, and osteotomies. It is a therapy device, not a diagnostic one.
No
The device description clearly describes a physical implantable screw made of Nitinol, which is a hardware component.
Based on the provided information, the dynaMX™ Nitinol Compression Screw is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for fixing fractures and performing arthrodesis and osteotomies in bones and joints. This is a therapeutic and structural function within the body.
- Device Description: The description details a physical screw made of Nitinol, designed to provide compression across a fracture site. This is a mechanical device used directly on the patient's anatomy.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, or urine) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples and provide diagnostic information. The dynaMX™ Nitinol Compression Screw is an implantable device used within the body for structural support and fixation.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
HWC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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, 2017 |
| See 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 Administration | |
| Office 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
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.
4
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.