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Aptus A-5043.90/1

by Medartis Inc.

Aptus A-5043.90/1 is a Class II device made by Medartis Inc., cleared under FDA 510(k) K202589 on 6 Nov 2020 and listed in FDA GUDID since 14 Nov 2020 (UDI-DI 07630037836667), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

Recall on shared 510(k) K202589; other models may be affected

Documents

510(k) K202589

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07630037836667 UDI-DI Date14 Nov 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK202589 Date6 Nov 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K202589 decided 6 Nov 2020 Active
  • FDA GUDID UDI-DI 07630037836667 listed 14 Nov 2020 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2361-2026 FDA Class II initiated 24 Apr 2026 on shared 510(k) K202589

    The cannulation of the CCS screw is not centered.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

3 dated events

  1. Cleared FDA 510(k) K202589
  2. Listed FDA GUDID 07630037836667
  3. Recall initiated FDA recalls Z-2361-2026

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Aptus
Generic name
Orthopaedic bone wire
Model / Ref / Catalog
A-5043.90/1
Primary DI / UDI-DI
07630037836667
510(k) Number
FDA product code
HTY
GMDN term
Orthopaedic bone wire
Device class
Class II
Regulation number
888.3040
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic bone wire

Cleared under the same submission (K202589)

and 8 more cleared under K202589

Other devices from Medartis Inc.

  • Avenger M70HC018

    Class II

  • Avenger M70HC020

    Class II

  • Avenger M70HC022

    Class II

  • Avenger M70HC024

    Class II

See all devices from Medartis Inc. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (11, all answered No)