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A'TOMIC Nitinol Fixation System

by Rmr Ortho, LLC

510(k) K232990

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK232990 Date12 Jan 2024ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 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  • Withdrawn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, 6 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 A'TOMIC Nitinol Fixation System is an orthopedic medical device designed for bone fixation. It utilizes shape-memory alloy technology to deliver continuous active compression for extremity and trauma applications.

The system is supplied as a sterile, single-use implant and is indicated for use in orthopedic procedures requiring compressive fixation. It is authorized under FDA 510(k) clearance K232990 with product code JDR.

Questions

AI-generated answers, 6 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 is the A'TOMIC Nitinol Fixation System used for?

    The A'TOMIC Nitinol Fixation System is designed for bone fixation in orthopedic procedures, utilizing shape-memory alloy technology to deliver continuous active compression specifically for extremity and trauma applications requiring compressive fixation.

  • How is the A'TOMIC Nitinol Fixation System supplied and is it reusable?

    The system is supplied as a sterile, single-use implant, meaning each device is intended for one procedure only and must not be reused to ensure patient safety and maintain sterility.

  • What regulatory authorization does the A'TOMIC Nitinol Fixation System have?

    The A'TOMIC Nitinol Fixation System is authorized under FDA 510(k) clearance K232990 with product code JDR, indicating it was found substantially equivalent to a legally marketed predicate device.