Skip to content

Ibalance Akrfx Medial Opening Wedge Tibial System, Ifx Medial Peek Implant And Anchor, Akrfx Instrumentation

by Ibalance Medical, Inc.

510(k) K092381

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 NumberK092381 Date27 Oct 2009ClearedStatusActive

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  • Withdrawn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, 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 Ibalance Akrfx Medial Opening Wedge Tibial System is a bone fixation plate system designed to provide fixation following proximal tibial procedures. The system comprises instrumentation, an IFX medial PEEK implant, and an anchor to support surgical stabilization.

This device is supplied by Ibalance Medical, Inc. and has received FDA 510(k) clearance under K092381. It is categorized as a bone fixation plate for orthopedic use.

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 Ibalance Akrfx Medial Opening Wedge Tibial System used for?

    The Ibalance Akrfx Medial Opening Wedge Tibial System is a bone fixation plate system designed to provide surgical stabilization and fixation following proximal tibial procedures.

  • What components are included in this tibial system?

    The system is a comprehensive set that includes specialized instrumentation, an IFX medial PEEK implant, and an anchor to support the fixation process.

  • What is the regulatory status of this orthopedic device?

    This device has received FDA 510(k) clearance under K092381, which indicates it has been determined to be substantially equivalent to legally marketed predicate devices.