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510(k) K242356

TIDAL Fusion Cage System by Restor3D, Inc. — Product Code SAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2025
Date Received
August 8, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ankle Fusion Cage
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type

Intended for use as an accessory to a tibiotalocalcaneal Intramedullary (IM) rod as part of a fusion construct for failed ankle arthrodesis or failed ankle arthroplasty. Not intended for standalone use.

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  • K243768 — iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System (March 27, 2025)
  • K242868 — Kinos Total Ankle System (October 18, 2024)
  • K241482 — Kinos Total Ankle System (July 22, 2024)
  • K240591 — restor3d Kinos Axiom Total Ankle System (April 29, 2024)
  • K234087 — restor3d TIDAL Lumbar Interbody Fusion System (January 22, 2024)
  • K232595 — Kinos Axiom Total Ankle System (November 28, 2023)
  • K231458 — Extremity Staple (August 3, 2023)

Other clearances for product code SAI

  • K230088 — Ankle Truss System (ATS) (March 21, 2024)