Class Class II
Pro-X1™ Trochanteric Nailing System (K221621)
Description
Pro-X1™ Trochanteric Nailing System by X-Bolt Orthopedics, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221621
Clearance Date2023-03-06
Clearance TypeTraditional
Product CodeHSB
Regulation Number888.3020
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221621
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. Pro-X1™ Trochanteric Nailing System (K221621) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K181640 | X-BOLT Hip Fracture Fixation System | X-Bolt Orthopaedics | 2018 |
| K034002 | GAMMA3 NAIL SYSTEM | Howmedica Osteonics Corp. | 2004 |
Trace the full predicate network for K221621
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.