# K061462: BF+ (PH)

- Pathway: 510(k) (Special)
- Applicant: Ldr Spine USA
- Decided: Dec 15, 2006 after 203 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.

## Indications for use
BF+ (Ph) resorbable void filler is a resorbable calcium salt bone void filler intended to fill bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis), caused by trauma or surgery, that are not intrinsic to the stability of the bony structure.

Source page: https://510kreport.com/device/K061462
Methodology: https://510kreport.com/methodology