# K000515: Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,

- Pathway: 510(k) (Traditional)
- Applicant: Interpore Cross Intl.
- Decided: Sep 15, 2000 after 212 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). 3 ancestors in all.
85 later devices descend from it; 2 cite it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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
- K012751: Healos Bone Graft Material (2001), 84 descendants of its own
- K043308: Modification to: Healos Bone Graft Material (2005), 67 descendants of its own
- K051386: Mastergraft Putty Bone Void Filler (2005), 59 descendants of its own
- K033679: Copsios Bone Void Filler (BVF) (2004), 54 descendants of its own
- K071813: Mastergraft Putty (2007), 47 descendants of its own

## Indications for use
Pro Osteon® 2008 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 2008 is indicated 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. Theproduct provides a bone graft substitute that resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K000515
Methodology: https://510kreport.com/methodology