# K020078: Exactech Resorbable Bone Paste

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Feb 27, 2004 after 779 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 K963562 (1997). 3 ancestors in all.
186 later devices descend from it; 8 cite it directly.
0 of 190 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963562: Wright Plaster of Paris Pellets, Wrightmedicaltechnologyinc (1997) Summary page 1.
- K011386: Ebi Osteostim Granules-Resorbable Bone Graft Substitute, Ebi, L.P. (2001) Summary page 1.
- 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) Summary page 1.

## Most influential descendants
- K060728: Novabone Putty - Bioactive Synthetic Graft (2006), 120 descendants of its own
- K080009: Novabone Putty- Bioactive Synthetic Graft (2008), 71 descendants of its own
- K082672: Novabone Putty-Bioactive Synthetic Bone Graft (2008), 59 descendants of its own
- K072184: Vitoss Bioactive Foam Bone Graft Substitute (2007), 51 descendants of its own
- K081439: Vitoss Bioactive Foam Pack Bone Graft Substitute (2008), 50 descendants of its own

## Indications for use
Exactech Resorbable Bone Paste is intended for use as a bone graft extender (extremities, spine, pelvis) and as a bone void filler for bony voids or gaps of the extremities and pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Exactech Resorbable Bone Paste may be used with rigid fixation systems.

Source page: https://510kreport.com/device/K020078
Methodology: https://510kreport.com/methodology