# K160058: Biomet Variable Pitch Compression Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Mar 9, 2016 after 57 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: 6 generations back to K915818 (1992). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092670: Biodrive Micro Screw System, Ebi,Llc D/B/A Biomet Trauma (2009) Summary page 4.

## Indications for use
The Variable Pitch Compression 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 part of trauma, deformity, osteoarthritis, and rheumatoid arthritis.

Source page: https://510kreport.com/device/K160058
Methodology: https://510kreport.com/methodology