# K050497: Bioscrew Xtralok, 8X35MM & 8X40MM Violet

- Pathway: 510(k) (Special)
- Applicant: Linvatec Corp.
- Decided: Mar 25, 2005 after 25 days
- Product code: HWC (Screw, Fixation, Bone)
- 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: 2 generations back to K973758 (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)
- K013131: Bioscrew Xtralok, Linvatec Corp. (2002) 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

## Indications for use
The BioScrew® XtraLok® 8 x 35mm and 8 x 40mm, violet provide tibial interference fixation of a soft tissue graft for ACL and PCL reconstruction.

Source page: https://510kreport.com/device/K050497
Methodology: https://510kreport.com/methodology