Class Class II
Protean Fragment Plating System (K241815)
Description
Protean Fragment Plating System by Skeletal Dynamics, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241815
Clearance Date2024-09-26
Clearance TypeTraditional
Product CodeHRS
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241815
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. Protean Fragment Plating System (K241815) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212433 | Anthem Fracture System | Globus Medical, Inc. | 2021 |
| K150099 | Depuy Synthes Variable Angle Locking Hand System (1.3 mm an... | Synthes (USA) Products, LLC | 2015 |
| K140372 | FRAGMENT PLATE SYSTEM | Skeletal Dynamics, LLC | 2014 |
| K112583 | SYNTHES CORTICAL SCREWS | Synthes (USA) Products, LLC | 2011 |
Trace the full predicate network for K241815
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.