# K071206: Actifuse Abx E-Z-Fil Putty Bone Graft Substitute

- Pathway: 510(k) (Special)
- Applicant: Apatech, Ltd.
- Decided: May 31, 2007 after 30 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: 4 generations back to K960978 (1996). 7 ancestors in all.
111 later devices descend from it; 12 cite it directly.
0 of 119 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040082: Pore-SI Bone Graft Substitute, Apatech, Ltd. (2004) Summary page 1.

## Most influential descendants
- K080736: Actifuse Shape Bone Graft Substitute (2008), 79 descendants of its own
- K151584: AttraX Putty (2015), 76 descendants of its own
- K191974: NuVasive AttraX Putty (2019), 71 descendants of its own
- K203714: NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty (2021), 66 descendants of its own
- K222276: CONDUIT Cages; FIBERGRAFT BG Putty (2022), 29 descendants of its own

## Recalls of this device
- Aug 18, 2015 · Class II · Z-1922-2016: Baxter Healthcare is issuing a voluntary recall for all lots of Actifuse ABX and Actifuse MIS System products with expiry before July 29, 2017 due to the possibility that the products may have endotox

## Indications for use
Actifuse is a bone void filler intended only for orthopaedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Actifuse is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e., extremities, pelvis, and spine, including use in posterolateral fusion procedures with appropriate stabilizing hardware. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by bone during the healing process

Source page: https://510kreport.com/device/K071206
Methodology: https://510kreport.com/methodology