# K193075: Osteo3 ZP Putty

- Pathway: 510(k) (Traditional)
- Applicant: Sirakoss, Ltd.
- Decided: Jun 9, 2020 after 218 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: 9 generations back to K960978 (1996). 38 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140375: Mastergraft Putty, Mastergraft Strip, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 4.
- K071206: Actifuse Abx E-Z-Fil Putty Bone Graft Substitute, Apatech, Ltd. (2007) Summary page 4.

## Most influential descendants
- K211201: MagnetOs Easypack Putty (2021), 3 descendants of its own
- K233607: MagnetOs Easypack Putty (2023), 2 descendants of its own
- K241212: MagnetOs Easypack Putty (2024), 1 descendant of its own
- K243474: MagnetOs MIS (2025), 0 descendants of its own

## Indications for use
Osteo3 ZP Putty is indicated for filling bone voids or defects of the skeletal system (i.e., the extremities, pelvis, and posterolateral spine) that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or as a result of traumatic injury to the bone. Osteo3 ZP Putty is a bone graft putty that is resorbed and replaced with bone during the healing process. Osteo3 ZP Putty must be used with morselized autograft bone at a ratio of 1:1 by volume in the posterolateral spine.

Source page: https://510kreport.com/device/K193075
Methodology: https://510kreport.com/methodology