510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K223326Substantially Equivalent

Axiom PSR System

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

K223326 is the FDA 510(k) clearance record for Axiom PSR System, a class II device, cleared for Restor3D on under FDA product code OYK (Ankle Arthroplasty Implantation System). FDA's definition for product code OYK reads: "Intended to be used to assist in the implantation of a specific ankle arthroplasty device. Indicated to include guiding alignment, making or establishing cuts, and sizing". FDA records list 19 510(k) clearances for Restor3D, from to . As of , FDA records show no recalls naming K223326.

Clearance record

Decision date
Received
(150 days to decision)
Product code
OYK Ankle Arthroplasty Implantation System
Regulation
21 CFR 888.3110
Device class
Class II
Review panel
Orthopedic
Applicant
Restor3D 404 Hunt St., Durham NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OYK

Trailing 12 months

FDA records hold no clearances under product code OYK in the trailing twelve months.

FDA records show no clearances under product code OYK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OYK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260