# K082949: Orthopediatrics Bone Screws

- Pathway: 510(k) (Traditional)
- Applicant: OrthoPediatrics Corp.
- Decided: Nov 25, 2008 after 54 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: 2 generations back to K862157 (1986). 13 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002271: 2.4MM Cortex Screw, Self-Tapping, Synthes (Usa) (2000) Summary page 1.
- K012945: Synthes 2.4 MM Cannulated Screw, Synthes (Usa) (2001) Summary page 1.
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 1.
- K043185: Synthes 3.5MM Cortex Screws, Synthes (Usa) (2005) Summary page 1.
- K962011: Synthes 7.0/7.3 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 1.
- K962823: Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer, Synthes (Usa) (1996) Summary page 1.
- K963172: Synthes Sterile 4.5 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 1.
- K963192: Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 1.
- K984209: Stainless Steel Taper Foreman Nail Cannulated Screw, Stainless Steel Cannulated Screw, Short Thread, Stainless Steel Ped, Biomet, Inc. (1999) Summary page 1.
- K043410: Epiphysis Screw, I.T.S. Implantat-Technologie-Systeme GmbH (2005) Summary page 1.

## Most influential descendants
- K111086: Orthopediatrics Fracture and Osteotomy Bone Plate System (2011), 7 descendants of its own
- K192181: PRECICE Plating System (2019), 2 descendants of its own
- K110959: Orthopediatrics Blade Plate System (2011), 2 descendants of its own
- K162307: OrthoPediatrics Locking Proximal Femur System Cortical Screws (2016), 1 descendant of its own
- K140431: Pediloc Fragment System (2014), 1 descendant of its own

## Indications for use
Cortical Screws are intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur and fibula. Large Cannulated Screws (4.5mm diameter and larger) are intended for fracture fixation of large bones and large bone fragments. Diameters 6.5mm and larger are intended for large bones and large bone fragments such as femoral neck fractures; slipped capital femoral epiphyses; tibial plateau fractures; ankle arthrodeses; pediatric femoral neck fractures; intercondylar femur fractures; and subtalar arthrodeses. Small Cannulated Screws (4.0mm diameter and smaller) are intended for fixation of fractures and non-unions of small bones and small bone arthrodeses. Examples include scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies.

Source page: https://510kreport.com/device/K082949
Methodology: https://510kreport.com/methodology