Class Class II
EMPOWR™ blade stem (K223779)
Description
EMPOWR™ blade stem by Encore Medical, LLC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223779
Clearance Date2023-02-13
Clearance TypeTraditional
Product CodeLPH
Regulation Number888.3358
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223779
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. EMPOWR™ blade stem (K223779) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K120030 | TAPERLOC COMPLETE SIZE 4MM AND XR 123 | Biomet Manufacturing Corp | 2012 |
| K120241 | LINEAR HIP STEM, SIZE 5 | Encore Medical L.P. | 2012 |
Trace the full predicate network for K223779
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.