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

FDA 510(k) K253577 · Medicrea International S.A.S. (Medtronic)

Substantially Equivalent

510(k) numberK253577

Submission

Device name
IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)
Applicant
Medicrea International S.A.S. (Medtronic)
Rillieux-La-Pape, FR
Received
November 17, 2025
Decision date
December 19, 2025
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3080
Specialty
Orthopedic
Implant
Yes

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other 510(k)s with product code MAX

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K261049Scala® TLMAX · Traditional Spineart SA08/20/2026SE
K261430TruLift Expandable SystemMAX · Traditional Life Spine, Inc.07/28/2026SE
K253011Catalyft PL Expandable Interbody SystemMAX · Traditional Medtronic Sofamor Danek USA, Inc.07/17/2026SE
K261020Symmetrix™ L Spinal SystemMAX · Traditional Medtronic Sofamor Danek USA, Inc.07/14/2026SE
K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…MAX · Traditional SeaSpine Orthopedics Corporation07/01/2026SE
K253151Fule Interbody Fusion Cage SystemMAX · Traditional Beijing Fule Science & Technology Development…06/15/2026SE
K261159Exceed® Biplanar Expandable Interbody SystemMAX · Traditional Spine Wave, Inc.05/29/2026SE
K253894BMD Titanium Spinal Fusion SystemMAX · Traditional Global Biomedica s.r.o.05/28/2026SE
K260506Ventana® P/T Lumbar Interbody SystemMAX · Traditional Spinal Elements, Inc.05/15/2026SE
K260837VersaLift Expandable SystemMAX · Traditional Life Spine, Inc.05/12/2026SE

More from Life Spine, Inc.

510(k)DeviceDecision
K261289UNiD™ Spine Analyzer (SW3002)QIH · Special 05/15/2026SE
K251629UNiD™ Spine AnalyzerQIH · Traditional 08/07/2025SE
K241164IB3D™ PL Spinal SystemMAX · Traditional 09/06/2024SE

Questions and answers

When was IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) cleared by the FDA?

IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) (K253577) received a 510(k) decision of Substantially Equivalent on December 19, 2025, 32 days after the submission was received.

What is the product code of K253577?

The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.