# K092898: Conmed Linvatec Presto Preloaded with One or Two #2 HI-FI Sutures

- Pathway: 510(k) (Special)
- Applicant: Conmed Linvatec
- Decided: Oct 19, 2009 after 28 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: 8 generations back to K911837 (1991). 57 ancestors in all.
No later device cites it as a predicate yet.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053561: Bio-Mini Revo Suture Anchor, Conmed Linvatec (2006) Summary page 1.
- K042778: Bioanchor with Disposable Driver, Preloaded with One #2 Herculine Suture, Linvatec Corp. (2004) Summary page 1.

## Indications for use
The anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The device 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/K092898
Methodology: https://510kreport.com/methodology