# K013131: Bioscrew Xtralok

- Pathway: 510(k) (Traditional)
- Applicant: Linvatec Corp.
- Decided: Jun 11, 2002 after 265 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: 1 generation back to K973758 (1998). 1 ancestor in all.
77 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)
- K973758: Bioscrew Absorbable Interference Srew, Linvatec Corp. (1998) Summary page 2.

## Most influential descendants
- K050497: Bioscrew Xtralok, 8X35MM & 8X40MM Violet (2005), 76 descendants of its own
- 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

## Recalls of this device
- Feb 22, 2005 · Not classified · Z-1551-05: 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 BioScrewB XtraLokTM interference screw provides tibial interference fixation of a soft tissue graft for ACL and PCL reconstruction.

Source page: https://510kreport.com/device/K013131
Methodology: https://510kreport.com/methodology