Class Class II
PROstep(TM) MIS 5mm Chamfer Screw System (K221645)
Description
PROstep(TM) MIS 5mm Chamfer Screw System by Wright Medical Technology, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221645
Clearance Date2023-02-17
Clearance TypeAbbreviated
Product CodeHWC
Regulation Number888.3040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221645
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. PROstep(TM) MIS 5mm Chamfer Screw System (K221645) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K203228 | DART-FIRE EDGE Cannulated Screw System | Wright Medical | 2021 |
| K162353 | MICATM Screw System | Wrightmedicaltechnologyinc | 2017 |
Trace the full predicate network for K221645
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.