# K033722: Apapore Bone Graft Substitute

- Pathway: 510(k) (Abbreviated)
- Applicant: Apatech, Ltd.
- Decided: May 7, 2004 after 163 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: 3 generations back to K960978 (1996). 5 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030131: Ossatura BCP Bone Void Filler, Isotis NV (2003) Summary page 1.

## Most influential descendants
- K051951: Cerament Bone Void Filler (2005), 10 descendants of its own
- K073316: Cerament Bone Void Filler, Model A0210 (2008), 6 descendants of its own
- K201535: Cerament Bone Void Filler (2020), 3 descendants of its own
- K212083: Tactoset Injectable Bone Substitute (2021), 2 descendants of its own
- K071004: Osteocrete Bone Void Filler (2009), 2 descendants of its own

## Indications for use
ApaPore® is used in open bone voids that may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. ApaPore® is intended for use on bone voids/gaps that are not intrinsic to the stability of the bony structure of the skeletal system, i.e., in the extremities, spine and pelvis. ApaPore® is intended to be carefully packed into bony voids or gaps of the skeletal system (i.e. the extremities, spine or pelvis). Following placement in the bony void, the synthetic bone void filler ApaPore® provides a scaffold for new mature host bone growth.

Source page: https://510kreport.com/device/K033722
Methodology: https://510kreport.com/methodology