Class Class II
ARTFX Trauma Bone Plate and Screw System (K242939)
Description
ARTFX Trauma Bone Plate and Screw System by Artfx Medical, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242939
Clearance Date2024-12-23
Clearance TypeTraditional
Product CodeHRS
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242939
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. ARTFX Trauma Bone Plate and Screw System (K242939) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K191793 | Nebula Brand Locking Bone Plates and Screws Osteosynthesis ... | Nebula Surgical Private Limited | 2019 |
| K171904 | Tandry Locking Plate System | Microware Precision Co., Ltd. | 2018 |
| K171808 | TDM Plate and Screw System | Tdm Co., Ltd. | 2018 |
| K161894 | SurgTech Trauma System | Surgtech, Inc. | 2017 |
Trace the full predicate network for K242939
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.