# K071912: Apaceram Bone Graft Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Corp.
- Decided: Oct 29, 2007 after 110 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: 5 generations back to K990131 (1999). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033722: Apapore Bone Graft Substitute, Apatech, Ltd. (2004) Summary page 1.
- K051774: MBCP, Biomatlante (2006) Summary page 1.

## Most influential descendants
- K120602: Apaceram Bone Graft Substitute (2012), 0 descendants of its own

## Indications for use
Apaceram TM Bone Graft Substitute is a synthetic hydroxyapatite provided in several particulate and shaped sizes. It is intended for use as a bone void filler for bony voids, gaps, or defects that are not intrinsic to the stability of the bony structure. ApaceramTM is intended to be placed into bony voids or gaps of the skeletal system (i.e. extremities, spine, or pelvis) caused by degeneration, trauma or surgery. It also can be used with autograft as a bone graft extender. ApaceramTM is resorbed and replaced with bone during the healing process.

Source page: https://510kreport.com/device/K071912
Methodology: https://510kreport.com/methodology