# K063346: Pro Osteon 500R

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, L.P.
- Decided: Apr 18, 2007 after 166 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: 5 generations back to K960978 (1996). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 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.
- K032286: Calcigen Psi Bone Graft Substitute, Biomet Orthopedics, Inc. (2003) Summary page 1.
- K051695: Marrow Plus (M+), Berkeley Advanced Biomaterials, Inc. (2005)
- K040047: Polygraft BGS; Bone Graft Substitute, Osteobiologics, Inc. (2004) Summary page 1.
- K043005: Modification to MBCP, Biomatlante (2005) Summary page 1.
- K051774: MBCP, Biomatlante (2006) Summary page 1.

## 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 extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PRO OSTEON® 500R can be combined with autogenous bone marrow aspirate, autogenous blood, and/or sterile fluids (saline or Ringer's solution). The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K063346
Methodology: https://510kreport.com/methodology