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510(k) K242868

Kinos Total Ankle System by Restor3d — Product Code HSN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2024
Date Received
September 20, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3110
Review Panel
OR
Submission Type

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  • 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 HSN

  • K252454 — Kinos Total Ankle System (September 3, 2025)
  • K250037 — Incompass Total Ankle System (June 20, 2025)
  • K250641 — APEX 3D Total Ankle Replacement System (May 1, 2025)
  • K240475 — Hintermann Series H2 Total Ankle System (December 2, 2024)
  • K241999 — Prophecy Surgical Planning System (November 1, 2024)
  • K241482 — Kinos Total Ankle System (July 22, 2024)
  • K240259 — APEX 3D Total Ankle Replacement System (June 24, 2024)
  • K240591 — restor3d Kinos Axiom Total Ankle System (April 29, 2024)
  • K231699 — QUANTUM® Patient Specific Instrumentation (PSI) System (April 23, 2024)
  • K232595 — Kinos Axiom Total Ankle System (November 28, 2023)