Fortilink Cages with TiPlus Technology
FDA 510(k) K201453 · Paradigm Spine GmbH
510(k) numberK201453
Submission
- Device name
- Fortilink Cages with TiPlus Technology
- Applicant
- Paradigm Spine GmbH
New York, NY, US - Received
- June 1, 2020
- Decision date
- October 7, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261049 | Scala® TLMAX · Traditional | Spineart SA | 08/20/2026SE |
| K261430 | TruLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 07/28/2026SE |
| K253011 | Catalyft PL Expandable Interbody SystemMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 07/17/2026SE |
| K261020 | Symmetrix L Spinal SystemMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 07/14/2026SE |
| K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…MAX · Traditional | SeaSpine Orthopedics Corporation | 07/01/2026SE |
| K253151 | Fule Interbody Fusion Cage SystemMAX · Traditional | Beijing Fule Science & Technology Development… | 06/15/2026SE |
| K261159 | Exceed® Biplanar Expandable Interbody SystemMAX · Traditional | Spine Wave, Inc. | 05/29/2026SE |
| K253894 | BMD Titanium Spinal Fusion SystemMAX · Traditional | Global Biomedica s.r.o. | 05/28/2026SE |
| K260506 | Ventana® P/T Lumbar Interbody SystemMAX · Traditional | Spinal Elements, Inc. | 05/15/2026SE |
| K260837 | VersaLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 05/12/2026SE |
More from Life Spine, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K213493 | Fortilink with TiPlus TechnologyODP · Traditional | 01/27/2022SE |
| K201704 | CoFix SystemPEK · Special | 08/04/2020SE |
| K153302 | coflex-IFPEK · Traditional | 09/08/2016SE |
| K120491 | DSS Stabilization System-RigidMNH · Traditional | 05/09/2012SESU |
| K112595 | Coflex-FKWP · Traditional | 02/13/2012SE |
| K113625 | DSS Stabilization SystemNKB · Special | 01/10/2012SESU |
| K093438 | Paradigm Interspinous Fusion PlateKWP · Traditional | 10/06/2010SE |
| K101083 | DSS Stabilization SystemNQP · Special | 07/02/2010SESU |
| K091944 | Modification to: DSS Stabilization SystemNQP · Special | 08/03/2009SE |
| K090099 | DSS Stabilization SystemNKB · Traditional | 06/19/2009SESU |
Questions and answers
When was Fortilink Cages with TiPlus Technology cleared by the FDA?
Fortilink Cages with TiPlus Technology (K201453) received a 510(k) decision of Substantially Equivalent on October 7, 2020, 128 days after the submission was received.
What is the product code of K201453?
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.