Class Class II
Consensus Knee System with TiNbN (K241180)
Description
Consensus Knee System with TiNbN by Shalby Advanced Technologies, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241180
Clearance Date2025-01-14
Clearance TypeTraditional
Product CodeJWH
Regulation Number888.3560
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241180
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. Consensus Knee System with TiNbN (K241180) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K182251 | EVOLUTION NitrX Medial-Pivot Knee | Mircoport Orthopedics, Inc. | 2019 |
| K122239 | FOUNDATION KNEE SYSTEM WITH TINBN COATING FOUNDATION PS KNE... | Encore Medical L.P. | 2013 |
| K110950 | CONSENSUS KNEE SYSTEM | Consensus Orthopedics, Inc. | 2011 |
Trace the full predicate network for K241180
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.