Class Class II
Monkey Bars Pin to Bar External Fixation System (K242452)
Description
Monkey Bars Pin to Bar External Fixation System by Paragon 28, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242452
Clearance Date2024-11-01
Clearance TypeTraditional
Product CodeKTT
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242452
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. Monkey Bars Pin to Bar External Fixation System (K242452) cites 3 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212895 | Paragon 28 External Ring Fixation System | Paragon 28, Inc. | 2021 |
| K211112 | OIC External Fixation System | Orthopaedic Implant Company | 2021 |
| K113770 | ORTHOFIX GALAXY FIXATION SYSTEM | Orthofix Srl | 2012 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K251862 | External Fixation Bone Distractor | Paragon 28, Inc. | 2025 |
Trace the full predicate network for K242452
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.