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AMIStem-C

by Medacta International S.A.

510(k) K193433

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 · Special NumberK193433 Date9 Jan 2020ClearedStatusActive

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  • Withdrawn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
LZO
Device Class
Class II
Regulation
21 CFR Part 888.3353
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 AMIStem-C is a hip stem device designed to facilitate hip stem insertion using the Anterior Minimally Invasive Surgery (AMIS) approach. This technique minimizes damage to periarticular structures and features a reduced lateral flare and optimized length to preserve bone and ease stem insertion.

The AMIStem-C is supplied as part of the AMIStem System and is intended for use in orthopedic procedures. It has received FDA 510(k) clearance with number K193433 and is classified under product code LZO. The device is designed to be used with specialized instrumentation as part of Medacta International's educational programs for surgeons.

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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 is the AMIStem-C used for?

    The AMIStem-C is used in orthopedic procedures, specifically for hip stem insertion using the Anterior Minimally Invasive Surgery (AMIS) approach, to minimize damage to periarticular structures.

  • Is the AMIStem-C supplied sterile?

    The description does not explicitly state that the AMIStem-C is supplied sterile, but it is intended for use in orthopedic procedures, suggesting it would be provided in a sterile or sterilizable condition.

  • What is the regulatory status of the AMIStem-C?

    The AMIStem-C has received FDA 510(k) clearance with number K193433, indicating it is substantially equivalent to a predicate device.