HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors (K241010)
Description
HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors by Depuy Mitek, an FDA 510(k) cleared orthopedic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241010
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. HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors (K241010) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201883 | 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance... | Medos International SARL | 2020 |
| K191242 | HEALIX ADVANCE SP BIOCOMPOSITE Anchor | Medos International SARL | 2019 |
| K182941 | HEALIX ADVANCE SP PEEK Anchor | Medos International SARL | 2019 |
| K180101 | HEALIX ADVANCE KNOTLESS BR Anchor | Medos International SARL | 2018 |
| K171114 | HEALIX ADVANCE KNOTLESS Anchor | Medos International SARL | 2017 |
Trace the full predicate network for K241010
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.