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Vitality® Spinal Fixation System

by Zimmer Biomet Spine, Inc. 510(k)

Active United States

510(k) K183550

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK183550 Date8 Apr 2019ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

23 recalls · FDA

  • 23 recalls, same reason

    • Terminated Z-2228-2020 FDA Class II initiated 5 May 2020
    • Terminated Z-2212-2020 FDA Class II initiated 5 May 2020
    • Terminated Z-2218-2020 FDA Class II initiated 5 May 2020
    • Terminated Z-2230-2020 FDA Class II initiated 5 May 2020
    • Terminated Z-2231-2020 FDA Class II initiated 5 May 2020
    • Terminated Z-2225-2020 FDA Class II initiated 5 May 2020
    • Terminated Z-2224-2020 FDA Class II initiated 5 May 2020
    • Terminated Z-2211-2020 FDA Class II initiated 5 May 2020
    • Terminated Z-2226-2020 FDA Class II initiated 5 May 2020
    • Terminated Z-2219-2020 FDA Class II initiated 5 May 2020
    • Terminated Z-2229-2020 FDA Class II initiated 5 May 2020
    • Terminated Z-2221-2020 FDA Class II initiated 5 May 2020
    • Terminated Z-2217-2020 FDA Class II initiated 5 May 2020
    • Terminated Z-2216-2020 FDA Class II initiated 5 May 2020
    • Terminated Z-2214-2020 FDA Class II initiated 5 May 2020
    • Terminated Z-2232-2020 FDA Class II initiated 5 May 2020
    • Terminated Z-2227-2020 FDA Class II initiated 5 May 2020
    • Terminated Z-2233-2020 FDA Class II initiated 5 May 2020 via K183550, on the same 510(k)
    • Terminated Z-2234-2020 FDA Class II initiated 5 May 2020
    • Terminated Z-2223-2020 FDA Class II initiated 5 May 2020
    • Terminated Z-2220-2020 FDA Class II initiated 5 May 2020
    • Terminated Z-2222-2020 FDA Class II initiated 5 May 2020
    • Terminated Z-2210-2020 FDA Class II initiated 5 May 2020

    There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
NKB
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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