Class Class II
BPS Wrist Fracture System (K242343)
Description
BPS Wrist Fracture System by Orthonovis, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242343
Clearance Date2024-10-04
Clearance TypeTraditional
Product CodeHRS
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242343
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. BPS Wrist Fracture System (K242343) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233919 | VariAx 2 Distal Radius System | Stryker GmbH | 2024 |
| K191641 | AFFINITY Variable Angle Distal Radius System, AFFINITY ... | Industrias Medicas Sampedro S.A.S | 2019 |
| K083694 | SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS ... | Synthes (Usa) | 2009 |
Trace the full predicate network for K242343
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.