Class Class II
Orthex External Fixation System (K223786)
Description
Orthex External Fixation System by OrthoPediatrics Corp., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223786
Clearance Date2023-02-10
Clearance TypeTraditional
Product CodeKTT
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223786
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. Orthex External Fixation System (K223786) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K170650 | Orthofix TrueLok Hexapod System (TL-HEX) V2.0 | Orthofix Srl | 2017 |
| K151881 | X-Fix Line Additions | Vilex IN Tennessee, Inc. | 2016 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243798 | Orthex External Fixation System | OrthoPediatrics Corp. | 2025 |
Trace the full predicate network for K223786
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.