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APTUS Hand Scaphoid Plates

by Medartis AG

510(k) K234062

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 NumberK234062 Date21 Mar 2024ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 26 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 Aptus Hand Scaphoid Plates are internal fixation devices designed to treat scaphoid fractures, including multifragmentary, complex, or very distal fractures. These locking plates are also indicated for the treatment of non-unions following previous conservative or operative treatment.

The plates are part of the Aptus Hand fixation system and are adapted to the specific shape of the scaphoid bone. This device has received FDA 510k clearance under the product code HRS.

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Questions

AI-generated answers, 26 Sep 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 the Aptus Hand Scaphoid Plates used for?

    These plates are internal fixation devices specifically designed to treat scaphoid fractures. They are indicated for various fracture types, including multifragmentary, complex, or very distal fractures, as well as for the treatment of non-unions that have occurred after previous conservative or operative treatment.

  • How are these plates adapted for the anatomy of the hand?

    The Aptus Hand Scaphoid Plates are specifically engineered to match the unique anatomical shape of the scaphoid bone. By providing a contoured fit, these locking plates facilitate the stabilization required for effective fracture healing within the Aptus Hand fixation system.

  • What is the regulatory status of the Aptus Hand Scaphoid Plates?

    The Aptus Hand Scaphoid Plates have received FDA 510k clearance under the product code HRS. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices for its intended use in orthopedic fixation.