Genesys Spine 3DP Lumbar Interbody System
FDA 510(k) K220096 · Genesys Spine
510(k) numberK220096
Submission
- Device name
- Genesys Spine 3DP Lumbar Interbody System
- Applicant
- Genesys Spine
Austin, TX, US - Received
- January 12, 2022
- Decision date
- March 9, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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.
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|---|---|---|---|
| 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 |
|---|---|---|
| K252322 | SIros-X SystemOUR · Traditional | 10/22/2025SE |
| K242483 | Genesys Spine AIS-C II Cervical Interbody Fusion SystemOVE · Traditional | 02/07/2025SE |
| K233595 | Genesys Spine Sacroiliac Joint Fusion System with NavigationOLO · Traditional | 03/29/2024SE |
| K233594 | Genesys Spine 3DP AIS-C II Cervical Interbody SystemOVE · Special | 12/13/2023SE |
| K191489 | Genesys Spine 3DP Cervical Interbody SystemOVE · Traditional | 01/08/2020SE |
| K182987 | Genesys Spine 3DP Lumbar Interbody SystemMAX · Traditional | 12/12/2019SE |
| K192678 | Genesys Spine Binary® Lumbar Plate SystemKWQ · Special | 10/24/2019SE |
| K191748 | Genesys Spine Sacroiliac Joint Fusion SystemOUR · Traditional | 09/26/2019SE |
| K192076 | Binary® Anterior Cervical Plate SystemKWQ · Special | 08/29/2019SE |
| K181295 | Genesys Spine AIS-C Cervical Stand-Alone SystemOVE · Traditional | 08/29/2018SE |
Questions and answers
When was Genesys Spine 3DP Lumbar Interbody System cleared by the FDA?
Genesys Spine 3DP Lumbar Interbody System (K220096) received a 510(k) decision of Substantially Equivalent on March 9, 2022, 56 days after the submission was received.
What is the product code of K220096?
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.