Class Class II
Exactech® Alteon® Short Tapered Wedge (K221323)
Description
Exactech® Alteon® Short Tapered Wedge by Exactech, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221323
Clearance Date2023-05-19
Clearance TypeTraditional
Product CodeLZO
Regulation Number888.3353
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221323
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. Exactech® Alteon® Short Tapered Wedge (K221323) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K140674 | EXACTECH TAPERED WEDGE FEMORAL STEM | Exactech, Inc. | 2014 |
| K110400 | TAPERLOC COMPLETE MICROPLASTY STEM | Biomet Manufacturing Corp | 2011 |
Trace the full predicate network for K221323
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.