# K071237: Copios Bone Void Filler Sponge and Paste

- Pathway: 510(k) (Special)
- Applicant: Kensey Nash Corp.
- Decided: Jun 1, 2007 after 29 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). 11 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033679: Copsios Bone Void Filler (BVF), Centerpulse Spine-Tech, Inc. (2004) Summary page 1.

## Most influential descendants
- K082419: Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1 (2009), 2 descendants of its own
- K101827: Osteoscaf (2011), 1 descendant of its own
- K213260: CMFlexTM (2022), 0 descendants of its own
- K072384: Modification to Copios Bone Void Filler Sponge & Paste (2007), 0 descendants of its own

## Indications for use
CopiOsTM Bone Void Filler, in combination with autologous blood products such as bone marrow, is intended for use only for filling bone voids or gaps of the skeletal system (i.e. extremities, pelvis, spine) that are not intrinsic to the stability of the bone structure. These voids may be a result of trauma or creation by surgeon. CopiOs Bone Void Filler is intended to be gently packed into the void or gap and will resorb during the course of the healing process,

Source page: https://510kreport.com/device/K071237
Methodology: https://510kreport.com/methodology