# K190324: OrthoPediatrics Cannulated Screw System

- Pathway: 510(k) (Traditional)
- Applicant: OrthoPediatrics Corp.
- Decided: Jul 5, 2019 after 142 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 3 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K140891: Biomet Cannulated Screw System, Biomet, Inc. (2014). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K012945: Synthes 2.4 MM Cannulated Screw, Synthes (Usa) (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K963172: Synthes Sterile 4.5 MM Cannulated Screws, Synthes (Usa) (1996). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K211290: Cannulated Fasteners and Nuts (2021), 2 descendants of its own
- K250251: Eleganz Fusion Screw System (Fusion Screw System) (2025), 0 descendants of its own
- K242691: OsteoCentric Technologies Cannulated Fasteners and Nuts (2024), 0 descendants of its own
- K230226: Integrity-SI® Fusion System (2023), 0 descendants of its own

## Indications for use
Small Cannulated Screws (2.5mm — 4.0mm diameter) Small Cannulated Screws (2.5mm - 4.0mm diameter) are intended for fixation of fractures and non-unions of small bones and small bone arthrodeses. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies. Large Cannulated Screws (4.5mm — 7.5mm diameter) Large Cannulated Screws (4.5mm — 7.5 mm diameter) are intended for fracture fixation of large bones and large bone fragments. Diameters 6.5 mm and larger are intended for large bones and large bone fragments such as slipped capital femoral epiphyses; pediatric femoral neck fractures; tibial plateau fractures; SI joint disruptions; intercondylar femur fractures; subtalar arthrodesis and fixation of pelvis and iliosacral joint.

Source page: https://510kreport.com/device/K190324
Methodology: https://510kreport.com/methodology