# K040454: Biofill Bone Void Filler

- Pathway: 510(k) (Traditional)
- Applicant: Scient'X
- Decided: May 7, 2004 after 74 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 K994337 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021963: Biosorb Resorbable Void Filler, Sciences ET Bio Materiaux (Sbm) (2003) Summary page 1.
- K994337: Vitoss Scaffold Synthetic Cancellous Bone Void Filler, Orthovita Co. (2000) Summary page 1.

## Indications for use
Biofill is intended for use only as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Biofill is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. Biofill should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. Biofill is intended to be gently packed into voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K040454
Methodology: https://510kreport.com/methodology