# K090850: Actifuse Bone Graft Substitute, Actifuse Microgranules Bone Graft Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Apatech, Ltd.
- Decided: Jul 30, 2009 after 122 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- Device class: 2
- Regulation: 21 CFR 872.3930
- 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: 6 generations back to K990131 (1999). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 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.
- K071206: Actifuse Abx E-Z-Fil Putty Bone Graft Substitute, Apatech, Ltd. (2007) Summary page 1.
- K080736: Actifuse Shape Bone Graft Substitute, Apatech, Ltd. (2008) Summary page 1.
- K082073: Actifuse Flow Bone Graft Substitute, Apatech, Ltd. (2008) Summary page 1.
- K081979: Actifuse Bone Graft Substitute and E-Z-Fil and Shape Bone Graft Substitute, Apatech, Ltd. (2008) Summary page 1.
- K082575: Actifuse Bone Graft Substitute and Abx E-Z-Fil and Shape Bone Graft Substitutes, Apatech, Ltd. (2008) Summary page 1.
- K060732: MBCP Gel, Biomatlante (2006) Summary page 1.
- K051885: MBCP, Biomatlante (2005) Summary page 1.
- K031813: Ossatura Dental, Isotis NV (2004) Summary page 2.
- K042706: Ossatura Dental, Isotis Orthobiologics, Inc. (2004) Summary page 2.

## 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 synthetic bone grafting material intended to fill, augment, and/or reconstruct maxillofacial osseous bone defects including periodontal, oral and craniomaxillofacial applications. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a synthetic bone grafting material that resorbs and is replaced by bone during the healing process.

Source page: https://510kreport.com/device/K090850
Methodology: https://510kreport.com/methodology