Class Class II
Stryker and Serf hip devices (K250989)
Description
Stryker and Serf hip devices by Howmedica Osteonics Corp (Dba Stryker Orthopaedics), an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250989
Clearance Date2025-07-25
Clearance TypeTraditional
Product CodeLPH
Regulation Number888.3358
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250989
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. Stryker and Serf hip devices (K250989) cites 3 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243784 | Stryker Orthopaedics Hip Devices Labeling Update | Howmedica Osteonics Corp., Dba Stry... | 2025 |
| K223745 | Novae® Dual Mobility System, Hype® Hip System | Serf | 2023 |
| K233498 | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stry... | 2023 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K253637 | Triathlon® Total Knee System - Triathlon® X3® Medial Stabil... | Howmedica Osteonics Corp., Dba Stry... | 2026 |
Trace the full predicate network for K250989
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.