Class Class II
Suture Button Repair System (K240835)
Description
Suture Button Repair System by Skeletal Dynamics, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240835
Clearance Date2024-07-19
Clearance TypeTraditional
Product CodeMBI
Regulation Number888.3040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240835
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. Suture Button Repair System (K240835) cites 3 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K182492 | Geminus Volar Distal Radius Plate System | Skeletal Dynamics, LLC | 2018 |
| K171060 | OrthoButton AL | Riverpoint Medical | 2017 |
| K100006 | HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPR... | Riverpoint Medical | 2010 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K261770 | Suture Button Repair System | Skeletal Dynamics, Inc. | 2026 |
Trace the full predicate network for K240835
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.