Class Class II
LORRAINE 2.5/3.5mm Distal Humerus System (K250933)
Description
LORRAINE 2.5/3.5mm Distal Humerus System by Bonebridge AG, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250933
Clearance Date2025-06-11
Clearance TypeTraditional
Product CodeHRS
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250933
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. LORRAINE 2.5/3.5mm Distal Humerus System (K250933) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231292 | TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Pr... | Bonebridge AG | 2023 |
| K120070 | SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM | Synthes USA | 2012 |
| K101056 | VARIAX ELBOW SYSTEM | Howmedica Osteonics Corp. | 2010 |
| K082807 | SYNTHES (USA) 3.5 AND 4.5 MM LOCKING COMPRESSION PLATE SYST... | Synthes (Usa) | 2008 |
Trace the full predicate network for K250933
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.