Class Class II
Advanced Bone Plate (K221150)
Description
Advanced Bone Plate by Double Medical Technology, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221150
Clearance Date2023-01-25
Clearance TypeTraditional
Product CodeHRS
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221150
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. Advanced Bone Plate (K221150) cites 6 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K171852 | DARCO Locking Bone Plate System | Wrightmedicaltechnologyinc | 2017 |
| K152974 | ORTHOLOC® 3Di Foot Plating Reconstruction System | Wrightmedicaltechnologyinc | 2015 |
| K141527 | DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM | Synthes USA | 2015 |
| K142121 | VALOR HINDFOOT FUSION NAIL SYSTEM | Wrightmedicaltechnologyinc | 2014 |
| K103243 | 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM | Synthes (Usa) | 2011 |
| K090692 | ORTHOLOC 2.0/2.4 PLATE SYSTEM | Wrightmedicaltechnologyinc | 2009 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242348 | Locking Screw,CoCrMo | Double Medical Technology, Inc. | 2024 |
Trace the full predicate network for K221150
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.