# K990131: Pro Osteon Implant 500R Resorbable Bone Graft Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Interpore Cross Intl.
- Decided: Mar 2, 1999 after 47 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
No predicates in its family tree.
224 later devices descend from it; 18 cite it directly.
0 of 225 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K020986: Mastergraft Resorbable Ceramic (2002), 158 descendants of its own
- K032268: MBCP (2003), 142 descendants of its own
- K043005: Modification to MBCP (2005), 122 descendants of its own
- K012751: Healos Bone Graft Material (2001), 84 descendants of its own
- K043308: Modification to: Healos Bone Graft Material (2005), 67 descendants of its own

## Indications for use
Pro Osteon 500R Resorbable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Pro Osteon 500R is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremeities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone graft substitute that resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K990131
Methodology: https://510kreport.com/methodology