Axiom PSR System— 510(k) K223326

Substantially Equivalent

Restor3D

FDA 510(k) clearance K223326 for Axiom PSR System, Substantially Equivalent on 2023-03-30. Applicant: Restor3D. Device class: 2.

Clearance details

Applicant: Restor3D
Product code: Product code OYK
Device class: Class 2
Regulation: 21 CFR 888.3110
Advisory panel: Orthopedic
Date received: 2022-10-31
Decision date: 2023-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OYK

K243173 — Salto Talaris Ankle PSI System2024-10-25
K243174 — Cadence Ankle PSI System2024-10-25
K241148 — Salto Talaris Ankle PSI System2024-08-30
K241326 — Cadence Ankle PSI System2024-08-30
K231585 — Vantage PSI System2023-06-30

More clearances from Restor3D

K260556 — Veritas Shoulder System2026-07-01
K253992 — Veritas Reverse Total Shoulder System2026-05-07
K252454 — Kinos Total Ankle System2025-09-03
K243643 — restor3d Reverse Total Shoulder Arthroplasty System2025-05-19
K242868 — Kinos Total Ankle System2024-10-18

Recalls naming K223326

K-number listed on FDA's recall record

Z-3178-2026 — Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006Class II·Ongoing·restor3d Inc.·20260727

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K223326.

Data sourced from openFDA. This site is unofficial and independent of the FDA.