# K020377: Pre-Loaded Biostinger Hornet

- Pathway: 510(k) (Traditional)
- Applicant: Linvatec Corp.
- Decided: May 6, 2002 after 90 days
- Product code: HWC (Screw, Fixation, Bone)
- 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: 2 generations back to K981692 (1998). 2 ancestors in all.
76 later devices descend from it; 1 cites it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991715: Biostinger-V Bioabsorbable Meniscal Repair Device, Linvatec Corp. (1999) Summary page 2.

## Most influential descendants
- K053561: Bio-Mini Revo Suture Anchor (2006), 75 descendants of its own
- K091549: Conmed Linvatec Soft Tissue to Bone System (2009), 56 descendants of its own
- K111779: Y-Knot All-Suture Anchor Model HF13 (2011), 29 descendants of its own
- K072291: Conmed Linvatec Bio Mini-Revo Suture Anchor (2008), 25 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

## Recalls of this device
- Feb 22, 2005 · Not classified · Z-1550-05: Linvatec has determined there is a possibility the pouch Tyvek header to foil longitudinal seal was not properly sealed by Bemis Flexible Packaging, in all pouches, prior to sterilization by Linvatec.

## Indications for use
The BioStinger™ Bioabsorbable Implant provides fixation of longitudinal vertical meniscus lesions (bucket handle tears) located in the vascular area of the meniscus.

Source page: https://510kreport.com/device/K020377
Methodology: https://510kreport.com/methodology