Class Class II
Extremity Medical External Fixation System (K251128)
Description
Extremity Medical External Fixation System by Extremity Medical, LLC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251128
Clearance Date2025-05-07
Clearance TypeSpecial
Product CodeKTT
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251128
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. Extremity Medical External Fixation System (K251128) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241563 | Extremity Medical External Fixation System | Extremity Medical, LLC | 2025 |
| K201253 | Modular Rail System, TAYLOR SPATIAL FRAME External Fixator,... | Smith & Nephew | 2020 |
| K161417 | DePuy Synthes MAXFRAME Multi-Axial Correction System | Synthes USA, LLC | 2016 |
Trace the full predicate network for K251128
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.