# K222589: Flexible Suturing System with Anchors (FSSA)

- Pathway: 510(k) (Traditional)
- Applicant: Integrity Orthopaedics, Inc.
- Decided: Jan 26, 2023 after 153 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K911837 (1991). 69 ancestors in all.
No later device cites it as a predicate yet.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091549: Conmed Linvatec Soft Tissue to Bone System, Linvatec Corp. (2009) Summary page 4.

## Indications for use
The Flexible Suturing System with Anchors (FSSA) is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

Source page: https://510kreport.com/device/K222589
Methodology: https://510kreport.com/methodology