# K031435: Bonesource BVF

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics
- Decided: Aug 4, 2003 after 90 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- 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 K873689 (1987). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021440: Bonesource Hac, Stryker Instruments (2002)
- K011897: Norian SRS Bone Void Filler, Synthes (Usa) (2001)

## Indications for use
The BoneSource® BVF is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. The BoneSource® BVF is intended to be placed or injected into bony voids or gaps of the skeletal system (i.e. extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K031435
Methodology: https://510kreport.com/methodology