# K013960: Apatight HA-Bone Graft Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Cerabio, LLC
- Decided: May 23, 2002 after 171 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.
4 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990131: Pro Osteon Implant 500R Resorbable Bone Graft Substitute, Interpore Cross Intl. (1999) 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
- K030178: Calcigen Psi Bone Graft Substitute (2003), 3 descendants of its own
- K032286: Calcigen Psi Bone Graft Substitute (2003), 1 descendant of its own
- K063346: Pro Osteon 500R (2007), 0 descendants of its own
- K050490: Osmosys Calcium Phosphate Ceramic Bone Filler (2005), 0 descendants of its own

## Indications for use
Apatight-HA Bone Graft Substitute is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. Apatight—HA is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K013960
Methodology: https://510kreport.com/methodology