# K121890: Genesys Pressft Suture Anchor

- Pathway: 510(k) (Special)
- Applicant: Linvatec Corporation D/B/A Conmed Linvatec
- Decided: Aug 22, 2012 after 55 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K911837 (1991). 106 ancestors in all.
No later device cites it as a predicate yet.
0 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112965: Nano Suture Anchor, Linvatec Corporation D/B/A Conmed Linvatec (2011) Summary page 1.
- K101100: Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503, Conmed Linvatec (2010) Summary page 1.

## Indications for use
The GENESYS PressFT Suture Anchor 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. Additional indications include acetabular labral repair and capsular repair in the hip.

Source page: https://510kreport.com/device/K121890
Methodology: https://510kreport.com/methodology