Class Class II
External Fixation Bone Distractor (K251862)
Description
External Fixation Bone Distractor by Paragon 28, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251862
Clearance Date2025-08-11
Clearance TypeTraditional
Product CodeKTT
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251862
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. External Fixation Bone Distractor (K251862) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242861 | TrueLok Elevate | Orthofix Srl | 2024 |
| K242452 | Monkey Bars Pin to Bar External Fixation System | Paragon 28, Inc. | 2024 |
| K232838 | Monkey RingsTM External Fixation System | Paragon 28, Inc. | 2023 |
Trace the full predicate network for K251862
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.