# K030131: Ossatura BCP Bone Void Filler

- Pathway: 510(k) (Traditional)
- Applicant: Isotis NV
- Decided: May 20, 2003 after 126 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 K960978 (1996). 4 ancestors in all.
133 later devices descend from it; 6 cite it directly.
0 of 138 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994337: Vitoss Scaffold Synthetic Cancellous Bone Void Filler, Orthovita Co. (2000) Summary page 1.
- K980817: Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L, Interpore Intl. (1998) Summary page 1.

## Most influential descendants
- K040082: Pore-SI Bone Graft Substitute (2004), 113 descendants of its own
- K071206: Actifuse Abx E-Z-Fil Putty Bone Graft Substitute (2007), 111 descendants of its own
- K090641: Curios (2009), 79 descendants of its own
- K080736: Actifuse Shape Bone Graft Substitute (2008), 79 descendants of its own
- K151584: AttraX Putty (2015), 76 descendants of its own

## Indications for use
OsSaturaTMBCP (Biphasic Calcium Phosphate) is bone void filler intended only for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. OsSaturaTMBCP is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e., extremities, spine, and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced by bone during the healing process.

Source page: https://510kreport.com/device/K030131
Methodology: https://510kreport.com/methodology