# K191513: Altapore Shape

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corporation
- Decided: Oct 19, 2019 after 134 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.
2 later devices descend 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)
- 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
- 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

## Indications for use
ALTAPORE SHAPE is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, pelvis and posterolateral spine). ALTAPORE SHAPE must be used in combination with autograft as a bone graft extender in posterolateral spinal fusion procedures. 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/K191513
Methodology: https://510kreport.com/methodology