Cleared Special

IB3D? PL Spinal System (A24000000 / IB3D Universal Implant Inserter)

K253577 · Medicrea International S.A.S. (Medtronic) · Orthopedic

Dec 2025

Decision

32d

Days

Class 2

Risk

About This 510(k) Submission

K253577 is an FDA 510(k) clearance for the IB3D? PL Spinal System (A24000000 / IB3D Universal Implant Inserter), a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Medicrea International S.A.S. (Medtronic) (Rillieux-La-Pape, FR). The FDA issued a Cleared decision on December 19, 2025, 32 days after receiving the submission on November 17, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K253577 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 17, 2025
Decision Date	December 19, 2025
Days to Decision	32 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.