# K132071: Bioactive Bone Graft Putty

- Pathway: 510(k) (Traditional)
- Applicant: Biostructures, LLC
- Decided: Jan 10, 2014 after 191 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K960978 (1996). 18 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071206: Actifuse Abx E-Z-Fil Putty Bone Graft Substitute, Apatech, Ltd. (2007) Summary page 1.
- K043005: Modification to MBCP, Biomatlante (2005) Summary page 1.
- K112857: Interface Bone Void Filler, Biostructures, LLC (2011) Summary page 1.
- K020078: Exactech Resorbable Bone Paste, Exactech, Inc. (2004) Summary page 1.

## Most influential descendants
- K171563: MagnetOs Putty (2017), 4 descendants of its own
- K211201: MagnetOs Easypack Putty (2021), 3 descendants of its own
- K233607: MagnetOs Easypack Putty (2023), 2 descendants of its own
- K241212: MagnetOs Easypack Putty (2024), 1 descendant of its own
- K243474: MagnetOs MIS (2025), 0 descendants of its own

## Recalls of this device
- Feb 13, 2019 · Class II · Z-1148-2019: The firm became aware of the potential for the products' sterile pouch to be punctured during transit. The packaging failure may introduce a non-sterile device that may lead to patient infection.

## Indications for use
Bioactive Bone Graft Putty is a bone void filler device intended for use in bony voids or gaps 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. Bioactive Bone Graft Putty is indicated to be packed gently into bony voids or gaps of the skeletal system (i.e., extremities, pelvis and posterolateral spine fusion procedures). Bioactive Bone Graft Putty can also be used with autograft as a bone graft extender in the posterolateral spine. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process.

Source page: https://510kreport.com/device/K132071
Methodology: https://510kreport.com/methodology