Class Class II
SIGNEX (K243469)
Description
SIGNEX by Osteonic Co., Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243469
Clearance Date2025-05-29
Clearance TypeTraditional
Product CodeHRS
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243469
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. SIGNEX (K243469) cites 8 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230546 | SIGNEX | Osteonic Co., Ltd. | 2024 |
| K110908 | APTUS FOOT 3.5 SYSTEM | Medartis AG | 2011 |
| K103332 | APTUS ULNA PLATES | Medartis AG | 2011 |
| K102998 | CONGRUENT BONE PLATE SYSTEM | Acumed, LLC | 2011 |
| K102537 | APTUS 1.5 TRILOCK | Medartis AG | 2010 |
| K091479 | APTUS FOOT SYSTEM | Medartis AG | 2009 |
| K090053 | APTUS 2.0 RADIAL HEAD SYSTEM | Medartis AG | 2009 |
| K051567 | APTUS TITANIUM OSTEOSYNTHESIS SYSTEM | Medartis, Inc. | 2005 |
Trace the full predicate network for K243469
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.