Class Class II
DeGen Medical Patient Specific Implant (PSI) System (K241077)
Description
DeGen Medical Patient Specific Implant (PSI) System by Degen Medical, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241077
Clearance Date2024-10-29
Clearance TypeTraditional
Product CodeOVD
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241077
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. DeGen Medical Patient Specific Implant (PSI) System (K241077) cites 4 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240326 | Solar™ Lumbar Interbody Fusion System | Degen Medical, Inc. | 2024 |
| K223418 | DeGen Impulse AM™ System | Degen Medical | 2023 |
| K182158 | UNiD Patient-matched PLIF cage | Medicrea International SA | 2019 |
| K173982 | FORTIFY Corpectomy Spacers | Globus Medical, Inc. | 2018 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250667 | DeGen Medical Patient Specific Implant (PSI) System | Degen Medical | 2025 |
Trace the full predicate network for K241077
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.