Class Class II
Bolo Button System (K242091)
Description
Bolo Button System by Fusion Orthopedics, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242091
Clearance Date2024-12-23
Clearance TypeTraditional
Product CodeHTN
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242091
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. Bolo Button System (K242091) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211843 | PolyLock Plating System | Fusion Orthopedics | 2022 |
| K202581 | Arthrex TightRope II | Arthrex, Inc. | 2020 |
| K162996 | INVISIKNOT Ankle Syndesmosis Repair Kit | Smith & Nephew, Inc. | 2017 |
| K130033 | TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMP... | Biomet Manufacturing Corp | 2013 |
Trace the full predicate network for K242091
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.