# K130531: Ultrafuse

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Apr 8, 2014 after 403 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: 5 generations back to K960978 (1996). 10 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 18 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.
- 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.

## Most influential descendants
- K181225: Altapore (2018), 6 descendants of its own
- K192363: Altapore (2020), 4 descendants of its own
- K191513: Altapore Shape (2019), 2 descendants of its own
- K201464: Altapore MIS (2020), 1 descendant of its own
- K200640: Altapore Shape (2020), 1 descendant of its own

## Indications for use
ALTAPORE is an implant intended to fill bony voids or gaps of the skeletal system i.e., extremities and pelvis. ALTAPORE can be used in combination with autograft as a bone graft extender in the extremities and pelvis. ALTAPORE can be used in combination with autogenous bone marrow aspirate in the extremities and pelvis. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. ALTAPORE resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K130531
Methodology: https://510kreport.com/methodology