dynaMX Nitinol Compression Screw

No FDA recalls found in the data synced 22 Oct 2026.

Full name

dynaMX(TM) Nitinol Compression Screw

510(k) Number

K160427 ↗

FDA Product Code

HWC

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• dynaMX™ Compression Plate

  Class II

  FDA 510(k) K161303 Active Cleared 26 Jan 2017

• dynaMX Compression Staple

  Class II

  FDA 510(k) K143622 Active Cleared 17 Jun 2015

• dynaMX Tabbed Staple

  Class II

  FDA 510(k) K153129 Active Cleared 28 Jan 2016

• What is the dynaMX Nitinol Compression Screw used for?

  The dynaMX Nitinol Compression Screw is an orthopedic device designed for fracture fixation. It provides superelastic compression at the fracture site as the bone remodels, helping to stabilize the fracture during healing.

• How is the dynaMX Nitinol Compression Screw supplied?

  The device is supplied by Mx Orthopedics, Corp. as part of their dynaMX portfolio, which also includes staples, plates, and intramedullary implants for fracture fixation. The specific packaging and quantities available would need to be confirmed directly with the manufacturer.

• What regulatory approvals does the dynaMX Nitinol Compression Screw have?

  The dynaMX Nitinol Compression Screw has received FDA 510(k) clearance with the product code HWC. It was determined to be substantially equivalent to predicate devices through the traditional clearance process, with a decision date of June 3, 2016.

• Is the dynaMX Nitinol Compression Screw reusable or single-use?

  The device data does not specify whether the dynaMX Nitinol Compression Screw is designed for single-use or reuse. This information would typically be found in the device's instructions for use, which should be consulted for proper handling and sterilization procedures.