# K142057: Infix Cannulated Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Infix Medical, LLC
- Decided: Jan 13, 2015 after 168 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: 8 generations back to K000684 (2000). 71 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962011: Synthes 7.0/7.3 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 4.
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 4.
- K963172: Synthes Sterile 4.5 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 4.
- K963192: Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 4.
- K962823: Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer, Synthes (Usa) (1996) Summary page 4.
- K012945: Synthes 2.4 MM Cannulated Screw, Synthes (Usa) (2001) Summary page 4.
- K111678: Ortho Solutions Extremity Fixation Implants for Osteosysnthesis, Ortho Solutions Limited (2012) Summary page 4.

## Most influential descendants
- K162874: Cannulated Screws Neoortho (2017), 0 descendants of its own

## Indications for use
InFix Cannulated Screw System is generally intended for fracture fixation of various bones and bone fragments, such as femoral neck, intercondylar femoral, malleolus, pilon tibial, calcaneus, talus, tibial plateau, tarsal, metatarsal, wrist, metacarpal, carpal, scaphoid and radius fracture. InFix Cannulated Screw System is also intended for fixation arthrodesis, iliosacral dislocations, and hallux valgus corrections. Accessories implants: The round washer is used to increase bone contact area for distributing the forces/load and prevent the screw head from sinking into the bone.

Source page: https://510kreport.com/device/K142057
Methodology: https://510kreport.com/methodology