# K072384: Modification to Copios Bone Void Filler Sponge & Paste

- Pathway: 510(k) (Special)
- Applicant: Kensey Nash Corp.
- Decided: Sep 21, 2007 after 28 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: 6 generations back to K960978 (1996). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071237: Copios Bone Void Filler Sponge and Paste, Kensey Nash Corp. (2007) Summary page 1.

## Cited in the summary but kept off the family tree
- K033678: Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035, 518-036, 518-037 and 518-038, Spectranetics Corp. (2004). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
CopiOs® 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 and spine, i.e., posterolateral spine fusion procedures with appropriate stabilizing hardware) 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/K072384
Methodology: https://510kreport.com/methodology