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Stratum™ Foot Plating System

by Nextremity Solutions, Inc.

510(k) K182201

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 closed

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 NumberK182201 Date16 Nov 2018ClearedStatusActive

Recalls

5 recalls · FDA

    • Terminated Z-1127-2020 FDA Class II initiated 16 Dec 2019

    The product contains a different plate than indicated by the package labeling. The product is labeled as a right plate but contains a left plate.

  • 3 recalls, same reason

    • Terminated Z-0777-2020 FDA Class II initiated 11 Nov 2019 on shared 510(k) K182201
    • Terminated Z-0778-2020 FDA Class II initiated 11 Nov 2019 on shared 510(k) K182201
    • Terminated Z-0776-2020 FDA Class II initiated 11 Nov 2019 on shared 510(k) K182201

    Components 2mm shorter than indicated on the package label

    • Terminated Z-0534-2020 FDA Class II initiated 9 Oct 2019

    Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect screw type and length

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  • Withdrawn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

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