# K031838: Profusion Bone Void Filler Kit

- Pathway: 510(k) (Traditional)
- Applicant: Biogeneration
- Decided: Oct 30, 2003 after 136 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) ProFusionB Graft Substitute Devices: named in the summary without a submission number
- (no number) Wright Medical Kits: 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 paste made with the ProFusionG3 Bone Graft Substitute Kits are intended to be injected, digitally packed into bone voids or gaps; or molded into solid pellets that are gently packed into bone voids or gaps that are not intrinsic to the stability of the bony structure of the skeletal system (i.e. long bones, extremities, spine and pelvis). The bone voids or gaps may be either surgically created or result from traumatic injury. The device provides a bone void filler that resorbs and is replaced with bone during the healing process. ProFusionO3 paste cured in situ provides a bone void or gap filler that can augment provisional hardware (e.9. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary scaffold and is not intended to provide support during the healing process. ProFusionO3 Bone Graft Substitute Kits are provided sterile for single use only. Because the devices are biodegradable and biocornpatible, they may be used at an infected site.

Source page: https://510kreport.com/device/K031838
Methodology: https://510kreport.com/methodology