# K032167: Bio-Intrafix Tibial Screw and Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Mitek Worldwide
- Decided: Oct 15, 2003 after 91 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: 4 generations back to K971358 (1997). 7 ancestors in all.
15 later devices descend from it; 4 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983560: Innovasive Devices Intratunnel Tibial Fixation Fastener, Innovasive Devices, Inc. (1999) Summary page 1.
- K013572: Mitek Biocryl Interference Screws, Mitek Products (2002)

## Most influential descendants
- K063577: Femoral Intrafix Screw and Sheath (2007), 7 descendants of its own
- K122123: 6-8MM X 30 MM Intrafix Peek Tapered Screw 7-9MM X 30MM Intrafix Peek Tapered Screw 8-10MM X 30 MM Intrafix Peek Tapered (2012), 5 descendants of its own
- K130539: Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM) (2013), 4 descendants of its own
- K131683: Healix Advance Knotless Peek Anchor (6.5MM) (2013), 3 descendants of its own
- K093912: Arthrex Tibial Graftbolt (2010), 3 descendants of its own

## Indications for use
The Bio-INTRAFIX Tibial Tapered Screw and Sheath are indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.

Source page: https://510kreport.com/device/K032167
Methodology: https://510kreport.com/methodology