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APTUS Foot System

by Medartis AG 3 variants

510(k) K091479

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

Recall on shared 510(k) K091479; other models may be affected

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 NumberK091479 Date13 Jul 2009ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-1550-2026 FDA Class II initiated 9 Jan 2026 on shared 510(k) K091479

    Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.

    • Ongoing Z-1821-2024 FDA Class II initiated 12 Apr 2024 on shared 510(k) K091479

    Screw is 16mm long instead of 22mm long.

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

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  • Withdrawn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, 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 APTUS Foot System is an orthopedic device designed for stabilization of fractures, arthrodesis, and osteotomies of the tarsals, metatarsals, and related foot bones. It includes multidirectional and angular stable implant plates in various designs, lengths, and widths, incorporating TriLock technology for anatomical adaptation and optimal fixation.

Supplied by Medartis AG, the system is intended for use in surgical settings to address patient-specific requirements in foot reconstruction. It is provided non-sterile and is reusable after appropriate cleaning and sterilization by the user. The device received FDA 510(k) clearance (K091479) as substantially equivalent to a predicate device, with product code HRS and review by the Orthopedic advisory committee.

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Questions

AI-generated answers, 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.

  • What is the APTUS Foot System used for?

    The APTUS Foot System is designed for stabilization of fractures, arthrodesis, and osteotomies of the tarsals, metatarsals, and related foot bones, addressing patient-specific requirements in foot reconstruction through its multidirectional and angular stable implant plates with TriLock technology.

  • How is the APTUS Foot System supplied and is it sterile?

    The APTUS Foot System is supplied non-sterile by Medartis AG and must be cleaned and sterilized by the user before each surgical use, as it is intended for reuse following appropriate reprocessing.

  • What regulatory pathway was used for the APTUS Foot System?

    The APTUS Foot System received FDA 510(k) clearance (K091479) as substantially equivalent to a predicate device, with product code HRS and review by the Orthopedic advisory committee.