Class Class II
OTS Hip (K250086)
Description
OTS Hip by Ortoma AB, an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250086
Clearance Date2025-05-16
Clearance TypeTraditional
Product CodeOLO
Regulation Number882.4560
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250086
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. OTS Hip (K250086) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232140 | OTS Hip | Ortoma AB | 2024 |
| K231503 | CUPTIMIZE Advanced | DePuy Orthopaedics, Inc. | 2023 |
Trace the full predicate network for K250086
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.