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dynaMX Intramedullary Implant

by Arthrex, Inc.

510(k) K170326

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK170326 Date20 Jul 2017ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
HTY
Device class
Class II
Regulation
21 CFR Part 888.3040
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The dynaMX Intramedullary Implant is a fixation device intended to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges. This implant is designed for intramedullary use in orthopedic procedures.

The device is supplied as a non-pyrogenic implant based on endotoxin testing. It received FDA 510(k) clearance with K number K170326 on July 20, 2017, after a 168-day review. The device is manufactured by Arthrex, Inc. and is indicated for use in orthopedic procedures.

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