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Arthrex DynaNite Nitinol Staples

by Arthrex, Inc. 2 variants

510(k) K243742

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK243742 Date31 Jan 2025ClearedStatusActive

Recalls

0 recalls · FDA

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

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  • Withdrawn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
JDR
Device class
Class II
Regulation
21 CFR Part 888.3030
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Arthrex DynaNite Nitinol Staples are a type of implant used for fixation procedures, providing compressive fixation. They are made of nitinol, a superelastic material. The staples are used in various orthopedic procedures.

The Arthrex DynaNite Nitinol Staples are supplied in different bridge lengths and widths, with 20 options available. They have received FDA 510K clearance, indicated by the k number K243742. The device is used in procedures such as LisFranc arthrodesis and osteotomies in the forefoot.

Other devices from Arthrex, Inc.

See all devices from Arthrex, Inc. →

Questions

AI-generated answers, 1 Oct 2026

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

  • What are DynaNite Nitinol Staples used for?

    The DynaNite Nitinol Staples are used for fixation procedures, such as LisFranc arthrodesis and osteotomies in the forefoot, providing compressive fixation.

  • What material are the staples made of?

    The staples are made of nitinol, a superelastic material, allowing for flexibility and strength in orthopedic procedures.

  • How many size options are available for the DynaNite Nitinol Staples?

    The staples are supplied in different bridge lengths and widths, with 20 options available to accommodate various patient needs and procedures.