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VERASENSE for Zimmer Biomet Persona

by Orthosensor Inc

510(k) K180459

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

6 closed

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 NumberK180459 Date7 Jun 2018ClearedStatusActive

Recalls

6 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-0084-2019 FDA Class II initiated 12 Jul 2018
    • Terminated Z-0085-2019 FDA Class II initiated 12 Jul 2018
    • Terminated Z-0087-2019 FDA Class II initiated 12 Jul 2018
    • Terminated Z-0086-2019 FDA Class II initiated 12 Jul 2018
    • Terminated Z-0082-2019 FDA Class II initiated 12 Jul 2018
    • Terminated Z-0083-2019 FDA Class II initiated 12 Jul 2018

    Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.

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  • Withdrawn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
ONN
FDA applicant
Orthosensor, Inc.
Device Class
Class II
Regulation
21 CFR Part 882.4560
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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