# K091549: Conmed Linvatec Soft Tissue to Bone System

- Pathway: 510(k) (Special)
- Applicant: Linvatec Corp.
- Decided: Jun 23, 2009 after 27 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K911837 (1991). 68 ancestors in all.
56 later devices descend from it; 6 cite it directly.
0 of 125 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963812: LM Bone Anchor (Orthopedics), Li Medical Technologies, Inc. (1996) Summary page 1.
- K073481: Threvo Anchor, Disposable Driver, HI-FI Sutures, Conmed Linvatec (2008) Summary page 1.
- K053561: Bio-Mini Revo Suture Anchor, Conmed Linvatec (2006) Summary page 1.

## Most influential descendants
- K111779: Y-Knot All-Suture Anchor Model HF13 (2011), 29 descendants of its own
- K131035: Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MM (2013), 17 descendants of its own
- K133224: Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2 Hifi Sutures (2014), 12 descendants of its own
- K163258: CrossFT Knotless Suture Anchor with Disposable Driver (2017), 9 descendants of its own
- K112965: Nano Suture Anchor (2011), 9 descendants of its own

## Recalls of this device
- Apr 17, 2017 · Class II · Z-0253-2018: Manufactured with the incorrect anchor outer body

## Indications for use
The ConMed Linvatec Soft Tissue to Bone System 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/K091549
Methodology: https://510kreport.com/methodology