Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology
FDA 510(k) K223153 · Medtronic Sofamor Danek USA, Inc.
510(k) numberK223153
Submission
- Device name
- Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology
- Applicant
- Medtronic Sofamor Danek USA, Inc.
Memphis, TN, US - Received
- October 6, 2022
- Decision date
- December 16, 2022
- 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 |
|---|---|---|
| K253011 | Catalyft PL Expandable Interbody SystemMAX · Traditional | 07/17/2026SE |
| K261020 | Symmetrix L Spinal SystemMAX · Traditional | 07/14/2026SE |
| K253656 | OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation SystemGEI · Traditional | 06/05/2026SE |
| K260216 | CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal SystemNKB · Traditional | 04/21/2026SE |
| K254165 | Infinity OCT SystemNKG · Special | 01/21/2026SE |
| K253941 | CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly)NKB · Special | 01/07/2026SE |
| K253335 | CD Horizon Spinal SystemNKB · Special | 10/24/2025SE |
| K253129 | Infinity OCT SystemNKG · Special | 10/24/2025SE |
| K251444 | Endoskeleton Interbody SystemsMAX · Traditional | 09/04/2025SE |
| K251395 | The Rialto SI Fusion SystemOUR · Traditional | 06/26/2025SE |
Questions and answers
When was Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology cleared by the FDA?
Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology (K223153) received a 510(k) decision of Substantially Equivalent on December 16, 2022, 71 days after the submission was received.
What is the product code of K223153?
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.