Class Class II
Flexible Suturing System with Anchors (FSSA) (K222589)
Description
Flexible Suturing System with Anchors (FSSA) by Integrity Orthopaedics, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222589
Clearance Date2023-01-26
Clearance TypeTraditional
Product CodeMBI
Regulation Number888.3040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222589
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. Flexible Suturing System with Anchors (FSSA) (K222589) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K091549 | CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM | Linvatec Corp. | 2009 |
Trace the full predicate network for K222589
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.