Class Class II
Simparo Anchor Line Fixation System (K222574)
Description
Simparo Anchor Line Fixation System by Simparo, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222574
Clearance Date2023-02-04
Clearance TypeTraditional
Product CodeMBI
Regulation Number888.3040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222574
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. Simparo Anchor Line Fixation System (K222574) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K140328 | CMC MINI TIGHTROPE | Arthrex, Inc. | 2014 |
| K060970 | AXYALOOP NONABSORBABLE BONE ANCHOR | Axya Medical, Inc. | 2006 |
Trace the full predicate network for K222574
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.