Class Class II
MUTARS® femoral stem cemented 160 mm and 200 mm (K240391)
Description
MUTARS® femoral stem cemented 160 mm and 200 mm by Implantcast GmbH, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240391
Clearance Date2024-10-24
Clearance TypeTraditional
Product CodeLZO
Regulation Number888.3353
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240391
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. MUTARS® femoral stem cemented 160 mm and 200 mm (K240391) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K200045 | MUTARS Cemented Femoral Stems | Implantcast GmbH | 2020 |
| K181778 | MUTARS Proximal Femur Replacement System | Implantcast GmbH | 2019 |
Trace the full predicate network for K240391
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.