# K042310: Ortho-Pro Cannulated Bone Screws

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Pro, LLC
- Decided: Sep 16, 2004 after 22 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: 1 generation back to K991151 (1999). 1 ancestor in all.
20 later devices descend from it; 4 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991151: Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw, Orthex Cannulated Bone Screw, Vilex, Inc. (1999) Summary page 1.

## Most influential descendants
- K143460: Cannulated Screw System (2015), 11 descendants of its own
- K180377: Fracture and Correction System (2018), 7 descendants of its own
- K061620: Ifs Cannulated Bone Screw (2006), 5 descendants of its own
- K161904: GEO Bone Screw System (2017), 4 descendants of its own
- K063589: Gso Bone Fixation Fasteners (2007), 4 descendants of its own

## Indications for use
The Ortho-Pro Cannulated Bone Screws are indicated for bone fractures, osteotomies, artrhodeses, osteochronditis and tendon reattachment. These screws are not intended for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Source page: https://510kreport.com/device/K042310
Methodology: https://510kreport.com/methodology