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Catalyft LS Expandable Interbody System

by Medtronic Sofamor Danek USA, Inc.

510(k) K212653

Catalyft LS Expandable Interbody System is a Class II device made by Medtronic Sofamor Danek USA, Inc., cleared under FDA 510(k) K212653 on 19 Nov 2021, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

7 ongoing

Recall on shared 510(k) K212653; other models may be affected

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK212653 Date19 Nov 2021ClearedStatusActive

Official records

Recalls

7 recalls · 7 ongoing · FDA

  • 7 recalls, same reason

    • Ongoing Z-2121-2023 FDA Class II initiated 6 Jun 2023 on shared 510(k) K212653
    • Ongoing Z-2118-2023 FDA Class II initiated 6 Jun 2023 on shared 510(k) K212653
    • Ongoing Z-2117-2023 FDA Class II initiated 6 Jun 2023 on shared 510(k) K212653
    • Ongoing Z-2123-2023 FDA Class II initiated 6 Jun 2023 on shared 510(k) K212653
    • Ongoing Z-2122-2023 FDA Class II initiated 6 Jun 2023 on shared 510(k) K212653
    • Ongoing Z-2119-2023 FDA Class II initiated 6 Jun 2023 on shared 510(k) K212653
    • Ongoing Z-2120-2023 FDA Class II initiated 6 Jun 2023 on shared 510(k) K212653

    There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

8 dated events

  1. Cleared FDA 510(k) K212653
  2. Recall initiated FDA recalls Z-2121-2023
  3. Recall initiated FDA recalls Z-2118-2023
  4. Recall initiated FDA recalls Z-2117-2023
  5. Recall initiated FDA recalls Z-2123-2023
  6. Recall initiated FDA recalls Z-2122-2023
  7. Recall initiated FDA recalls Z-2119-2023
  8. Recall initiated FDA recalls Z-2120-2023

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
MAX
Device class
Class II
Regulation
21 CFR Part 888.3080
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

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