# K973704: Profusion Bone Void Filler

- Pathway: 510(k) (Traditional)
- Applicant: Biogeneration
- Decided: Apr 3, 1998 after 186 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
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 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 its predicate without a number.
- (no number) Wright Plaster of Paris Pellets (also named Osteoset® Pellets): named in the summary without a submission number

## Most influential descendants
- K051406: Osteocure Resorbable Bead Kit (2005), 3 descendants of its own
- K071004: Osteocrete Bone Void Filler (2009), 2 descendants of its own
- K212991: Osteorevive (2022), 1 descendant of its own
- K221256: Mg OSTEOINJECT (2022), 0 descendants of its own

## Indications for use
The ProFusion™ implants are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The implant is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. long bones, extremities, spine and pelvis). The bony cavities may be surgically created or the result of traumatic injury. The implant provides a bone graft substitute that resorbs and is replaced with bone during the healing process. Because the implant is biodegradable and biocompatible, it may be used at an infected site.

Source page: https://510kreport.com/device/K973704
Methodology: https://510kreport.com/methodology