# K201464: Altapore MIS

- Pathway: 510(k) (Special)
- Applicant: Baxter Healthcare Corporation
- Decided: Jun 30, 2020 after 28 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: 11 generations back to K960978 (1996). 43 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192363: Altapore, Baxter Healthcare Corporation (2020) Summary page 5.
- K082575: Actifuse Bone Graft Substitute and Abx E-Z-Fil and Shape Bone Graft Substitutes, Apatech, Ltd. (2008) Summary page 5.

## Most influential descendants
- K241564: Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS (2024), 0 descendants of its own

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

Source page: https://510kreport.com/device/K201464
Methodology: https://510kreport.com/methodology