# K082874: Biodrive Cannulated Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Trauma
- Decided: Feb 5, 2009 after 129 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: 3 generations back to K922322 (1992). 16 ancestors in all.
168 later devices descend from it; 6 cite it directly.
0 of 185 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024086: Propeller Head Small Cannulated Screw System, Biomet Orthopedics, Inc. (2003) Summary page 1.
- K070955: Acid Etched Lag Screws, Biomet Orthopedics, Inc. (2007) 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.
- K040765: Synthes 5.0/7.3 MM Cannulated Locking Screws, Synthes (Usa) (2004) Summary page 1.
- K962011: Synthes 7.0/7.3 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 1.
- K963172: Synthes Sterile 4.5 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.
- K051296: Sijf Cannulated Screw System, Depuy Spine, Inc. (2005)

## Most influential descendants
- K093629: Solitaire and Solitaire Peek Anterior Spinal System (2010), 143 descendants of its own
- K113796: Solitaire-C Cervical Spacer System (2012), 142 descendants of its own
- K132029: Vault-C Intervertebral Body Fusion Device (2013), 108 descendants of its own
- K190546: NEXXT MATRIXX Stand Alone Cervical System (2019), 93 descendants of its own
- K200543: NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System (2020), 72 descendants of its own

## Indications for use
The BioDrive® Cannulated Screw System is indicated for the following: Fixation of fractures in long bones Fixation of small bones, including those in the foot, patella, ankle, wrist & elbow Arthrodesis of the foot, wrist and elbow Small and long bone osteotomies Fixation of pelvis and the illiosacral joint

Source page: https://510kreport.com/device/K082874
Methodology: https://510kreport.com/methodology