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CalcShift Displacement Calcaneal Osteotomy System

by Nextremity Solutions, Inc.

510(k) K212979

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK212979 Date20 May 2022ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 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  • Withdrawn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, 21 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 CalcShift Displacement Calcaneal Osteotomy System is a bone fixation system used for osteotomies, nonunions, malunions, revisions, fusions, and reconstruction of the calcaneus requiring a medial or lateral displacement osteotomy. It is classified as a Plate, Fixation, Bone within the HRS classification. The system is designed to provide a solution for various calcaneal procedures.

The CalcShift Displacement Calcaneal Osteotomy System is supplied as a single-use device and is intended for use in orthopedic procedures. It has received FDA 510(k) clearance under the approval number K212979. The device is manufactured by Nextremity Solutions, Inc. and is available for use in medical settings.

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Questions

AI-generated answers, 21 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 CalcShift Displacement Calcaneal Osteotomy System used for?

    The CalcShift Displacement Calcaneal Osteotomy System is used for osteotomies, nonunions, malunions, revisions, fusions, and reconstruction of the calcaneus requiring a medial or lateral displacement osteotomy.

  • Is the CalcShift Displacement Calcaneal Osteotomy System a single-use device?

    Yes, the CalcShift Displacement Calcaneal Osteotomy System is supplied as a single-use device and is intended for use in orthopedic procedures.

  • What regulatory clearance has the CalcShift Displacement Calcaneal Osteotomy System received?

    The CalcShift Displacement Calcaneal Osteotomy System has received FDA 510(k) clearance under the approval number K212979.