# K192363: Altapore

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corporation
- Decided: Jan 9, 2020 after 132 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: 10 generations back to K960978 (1996). 42 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181225: Altapore, Baxter Healthcare Corporation (2018) Summary page 5.
- K140375: Mastergraft Putty, Mastergraft Strip, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 5.

## Most influential descendants
- K201464: Altapore MIS (2020), 1 descendant of its own
- K200640: Altapore Shape (2020), 1 descendant of its own
- K241564: Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS (2024), 0 descendants of its own
- K233259: Xerosyn (2024), 0 descendants of its own

## Indications for use
ALTAPORE is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis). ALTAPORE 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 resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K192363
Methodology: https://510kreport.com/methodology