Class Class II
Pediatric Plating Platform Hip (K243963)
Description
Pediatric Plating Platform Hip by OrthoPediatrics Corp., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243963
Clearance Date2025-04-29
Clearance TypeTraditional
Product CodeHRS
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243963
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. Pediatric Plating Platform Hip (K243963) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K210837 | Smith & Nephew Plates and Screws | Smith & Nephew, Inc. | 2021 |
| K162307 | OrthoPediatrics Locking Proximal Femur System Cortical Screws | OrthoPediatrics Corp. | 2016 |
| K111086 | ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM | OrthoPediatrics Corp. | 2011 |
| K072095 | SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS | Synthes (Usa) | 2007 |
Trace the full predicate network for K243963
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.