# K033679: Copsios Bone Void Filler (BVF)

- Pathway: 510(k) (Traditional)
- Applicant: Centerpulse Spine-Tech, Inc.
- Decided: Jul 7, 2004 after 226 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: 4 generations back to K960978 (1996). 10 ancestors in all.
54 later devices descend from it; 4 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012751: Healos Bone Graft Material, Orquest, Inc. (2001) Summary page 1.
- K994337: Vitoss Scaffold Synthetic Cancellous Bone Void Filler, Orthovita Co. (2000) 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.
- K990131: Pro Osteon Implant 500R Resorbable Bone Graft Substitute, Interpore Cross Intl. (1999) Summary page 1.
- K000515: Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,, Interpore Cross Intl. (2000) Summary page 1.
- K974399: Bio-Oss Collagen, Geistlich-Pharma (1998) Summary page 1.
- (no number) Pro Osteon Implant 50OR Resorbable Bone Graft Filler/Bone Graft Material; 200R Resorbable Bone Graft Material: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K000122: Collagraft Strip Bone Graft Matrix (for Use as a Bone Filler), Model 1X,3X,6X (1,3 or 6 Strips Per Box), Neucoll, Inc. (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K052812: Ossimend (TM) Bone Graft Material (2006), 40 descendants of its own
- K082166: Mastergraft Strip (2009), 38 descendants of its own
- K140375: Mastergraft Putty, Mastergraft Strip (2014), 30 descendants of its own
- K060917: Kensey Nash Bone Void Filler (2006), 7 descendants of its own
- K181225: Altapore (2018), 6 descendants of its own

## Indications for use
CopiOsTM BVF, in combination with autologous 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. CopiOsTM BVF 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/K033679
Methodology: https://510kreport.com/methodology