Class Class II
Z1 Cemented Hip System (K241241)
Description
Z1 Cemented Hip System by Orchard Medical Development, LLC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241241
Clearance Date2024-08-27
Clearance TypeTraditional
Product CodeLZO
Regulation Number888.3353
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241241
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. Z1 Cemented Hip System (K241241) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233476 | Z1 Hip System | Orchard Medical Development | 2024 |
| K193030 | Avenir Muller Stem, Avenir Cemented Hip Stem | Zimmer GmbH | 2019 |
| K120030 | TAPERLOC COMPLETE SIZE 4MM AND XR 123 | Biomet Manufacturing Corp | 2012 |
Trace the full predicate network for K241241
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.