# K120602: Apaceram Bone Graft Substitute

- Pathway: 510(k) (Special)
- Applicant: Hoya Corporation
- Decided: Mar 23, 2012 after 24 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: 6 generations back to K990131 (1999). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071912: Apaceram Bone Graft Substitute, Pentax Corp. (2007) Summary page 1.

## 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. Apaceram" is intended to be placed into bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine, or pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. It also can be used with autograft as a bone graft extender. Apaceramwm is resorbed and replaced with bone during the healing process.

Source page: https://510kreport.com/device/K120602
Methodology: https://510kreport.com/methodology