DeGen Medical Patient Specific Implant (PSI) System
FDA 510(k) K251829 · Degen Medical
510(k) numberK251829
Submission
- Device name
- DeGen Medical Patient Specific Implant (PSI) System
- Applicant
- Degen Medical
Florence, SC, US - Received
- June 13, 2025
- Decision date
- December 8, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
Other 510(k)s with product code OVD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262025 | Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…OVD · Traditional | INNO Holdings Inc. DBA Innovasis | 09/11/2026SE |
| K261408 | SABER-XA SystemOVD · Traditional | Elevation Spine | 08/03/2026SE |
| K261809 | Interwedge® Standalone LateralOVD · Special | Foundation Surgical Group | 07/31/2026SE |
| K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…OVD · Traditional | Kyocera Medical Technologies, Inc. | 07/15/2026SE |
| K260810 | Anteralign LS coverplateOVD · Traditional | Tyber Medical, LLC | 06/10/2026SE |
| K254202 | MectaLIF 3D Metal AnteriorOVD · Traditional | Medacta International S.A. | 05/05/2026SE |
| K253401 | SCRIPT Implant SystemOVD · Traditional | Globus Medical, Inc. | 04/29/2026SE |
| K253559 | Ventana A Anterior Lumbar Interbody SystemOVD · Traditional | Spinal Elements, Inc. | 02/25/2026SE |
| K251575 | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody SystemOVD · Traditional | Alphatec Spine | 09/03/2025SE |
| K250072 | CONDUIT SYNFIX Evolution Secured Spacer SystemOVD · Traditional | Avalign Technologies, Inc. | 07/10/2025SE |
More from Avalign Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252737 | DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemODP · Traditional | 10/10/2025SE |
| K250667 | DeGen Medical Patient Specific Implant (PSI) SystemMAX · Special | 04/04/2025SE |
| K241077 | DeGen Medical Patient Specific Implant (PSI) SystemOVD · Traditional | 10/29/2024SE |
| K240326 | Solar Lumbar Interbody Fusion SystemMAX · Traditional | 07/29/2024SE |
| K231199 | Solar Lumbar Interbody Fusion SystemMAX · Traditional | 06/16/2023SE |
| K223418 | DeGen Impulse AM SystemMAX · Traditional | 03/17/2023SE |
| K213918 | DeGen Navigated InstrumentationOLO · Traditional | 02/09/2022SE |
| K213901 | Cyclops Anterior Cervical Plate SystemKWQ · Special | 01/07/2022SE |
| K210090 | Impulse AM Interbody Fusion SystemMAX · Traditional | 08/30/2021SE |
| K203816 | DeGen Navigated InstrumentationOLO · Traditional | 04/02/2021SE |
Questions and answers
When was DeGen Medical Patient Specific Implant (PSI) System cleared by the FDA?
DeGen Medical Patient Specific Implant (PSI) System (K251829) received a 510(k) decision of Substantially Equivalent on December 8, 2025, 178 days after the submission was received.
What is the product code of K251829?
The FDA product code is OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.