Class Class II
ANTHEM® Fracture System (K251161)
Description
ANTHEM® Fracture System by Globus Medical, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251161
Clearance Date2025-08-18
Clearance TypeTraditional
Product CodeHRS
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251161
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. ANTHEM® Fracture System (K251161) cites 6 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expan... | Globus Medical, Inc. | 2022 |
| K213591 | ANTHEM® Fracture System | Globus Medical, Inc. | 2022 |
| K212433 | Anthem Fracture System | Globus Medical, Inc. | 2021 |
| K202496 | ANTHEM Fracture System | Globus Medical, Inc. | 2020 |
| K163361 | ANTHEM Fracture System | Globus Medical, Inc. | 2017 |
| K120070 | SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM | Synthes USA | 2012 |
Trace the full predicate network for K251161
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.