# K092670: Biodrive Micro Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi,Llc D/B/A Biomet Trauma
- Decided: Nov 19, 2009 after 80 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K915818 (1992). 28 ancestors in all.
68 later devices descend from it; 5 cite it directly.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050681: Omnitech System & Easy Lock Osteosystem with Xtremities Plates, TriMed, Inc. (2005) Summary page 2.
- K013534: Self-Countersinking Bone Screw, Biomet Orthopedics, Inc. (2001) Summary page 2.
- K030706: Ebi Dynafix Compression Bone Screw, Ebi, L.P. (2003) Summary page 2.

## Most influential descendants
- K111678: Ortho Solutions Extremity Fixation Implants for Osteosysnthesis (2012), 58 descendants of its own
- K141784: Ortho Solutions Ultos Plating System (2014), 28 descendants of its own
- K131722: I.T.S. Extremity Fixation Systems (2013), 24 descendants of its own
- K162674: BioPro Foot Plating Systems (2017), 19 descendants of its own
- K131061: Restore Bunion Correction System (2013), 15 descendants of its own

## Indications for use
The Biomet BioDrive Screw System is indicated for alignment and stabilization of small bone fractures. Specifically: * Fixation of small bones, such as those in the foot, ankle, wrist, elbow and hand for treatment of fractures, non-unions, or mal-unions * Ligament reconstruction * Osteochondritis dissecans * Arthrodesis of the foot, ankle, wrist, elbow and hand * Small bone osteotomies, including first metatarsal head osteotomy, metatarsal osteotomies, phalangeal osteotomies, and carpal/metacarpal osteotomies These procedures may be indicated as a result of trauma, deformity, osteoarthritis, and rheumatoid arthritis.

Source page: https://510kreport.com/device/K092670
Methodology: https://510kreport.com/methodology