# K964970: Biomet Bone Screw

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Apr 3, 1997 after 112 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.
334 later devices descend from it; 2 cite it directly.
0 of 335 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K030900: Inion Otps Biodegradable Fixaton System (2003), 333 descendants of its own
- K043248: Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS (2005), 306 descendants of its own
- K052776: Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257, AR-TBD (2005), 217 descendants of its own
- K083070: Toggleloc System (2008), 94 descendants of its own
- K112437: Arthrex Fracture System (2011), 91 descendants of its own

## Indications for use
The Biomet Bone Screw is indicated for ankle fractures, metatarsal fusions and metatarsal osteotomies (Hallux Valgus).

Source page: https://510kreport.com/device/K964970
Methodology: https://510kreport.com/methodology