Class Class II
Salto Talaris Ankle PSI System (K241148)
Description
Salto Talaris Ankle PSI System by 3D Systems, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241148
Clearance Date2024-08-30
Clearance TypeTraditional
Product CodeOYK
Regulation Number888.3110
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241148
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. Salto Talaris Ankle PSI System (K241148) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K193432 | Vantage PSI System | 3D Systems | 2020 |
| K182878 | Integra Salto Total Ankle System | Ascension Orthopedics | 2018 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243173 | Salto Talaris Ankle PSI System | 3D Systems, Inc. | 2024 |
Trace the full predicate network for K241148
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.