# K980817: Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L

- Pathway: 510(k) (Traditional)
- Applicant: Interpore Intl.
- Decided: Sep 25, 1998 after 206 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: 1 generation back to K960978 (1996). 2 ancestors in all.
312 later devices descend from it; 11 cite it directly.
0 of 315 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960978: Wright Plaster of Paris Pellets (Subject to Revision), Wrightmedicaltechnologyinc (1996) Summary page 2.
- K963562: Wright Plaster of Paris Pellets, Wrightmedicaltechnologyinc (1997) Summary page 2.

## Most influential descendants
- K021336: Novabone-Resorbable Bone Graft Substitute (2002), 162 descendants of its own
- K030131: Ossatura BCP Bone Void Filler (2003), 133 descendants of its own
- K052494: Novabone-Bioactive Synthetic Graft (2005), 123 descendants of its own
- K060728: Novabone Putty - Bioactive Synthetic Graft (2006), 120 descendants of its own
- K040082: Pore-SI Bone Graft Substitute (2004), 113 descendants of its own

## Indications for use
Pro Osteon® 500R Resorbable Bone Void Filler is indicated only for bony voide 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 extremities, 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 void filler that resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K980817
Methodology: https://510kreport.com/methodology