# K033258: Bonesave Bone Void Filler

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics
- Decided: Mar 9, 2004 after 152 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: 2 generations back to K963587 (1997). 5 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991854: Osteoplast, Model POP200, Interpore Cross Intl. (1999) Summary page 1.
- K020986: Mastergraft Resorbable Ceramic, Medtronic Sofamor Danek, Inc. (2002) Summary page 1.

## Most influential descendants
- K063157: Merries K-Phate Bone Graft Substitute (2008), 0 descendants of its own
- K071121: Tribone 80 (2007), 0 descendants of its own
- K063527: MBCP+ (2007), 0 descendants of its own

## Indications for use
BoneSaveTM Calcium phosphate granules (20cc) are indicated for osseous defect filling of bones not intrinsic to stability of the bony structure. BoneSaveTM Calcium phosphate granules are indicated to be gently packed into osseous defects (i.e. bony voids or gaps) of the skeletal system (i.e., the extremities, spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Source page: https://510kreport.com/device/K033258
Methodology: https://510kreport.com/methodology