510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K252454Substantially Equivalent

Kinos Total Ankle System

restor3d, Inc., Durham NC / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K252454 is the FDA 510(k) clearance record for Kinos Total Ankle System, a class II device, cleared for Restor3D on under FDA product code HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer). FDA records list 19 510(k) clearances for Restor3D, from to . As of , FDA records show no recalls naming K252454.

Clearance record

Decision date
Received
(30 days to decision)
Product code
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Regulation
21 CFR 888.3110
Device class
Class II
Review panel
Orthopedic
Applicant
Restor3D 4001 Nc 54 Hwy., Durham NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HSN

Trailing 12 months
1 clearance under product code HSN in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HSN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260