# K090460: Bonos Inject

- Pathway: 510(k) (Abbreviated)
- Applicant: Aap Biomaterials GmbH
- Decided: Apr 14, 2009 after 50 days
- Product code: NDN (Cement, Bone, Vertebroplasty)
- Device class: 2
- Regulation: 21 CFR 888.3027
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to P810020 (1984). 3 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050085: Osteopal V, Heraeus Kulzer,GmbH (2005) Summary page 1.

## Most influential descendants
- K202458: BonOs Inject, Pedicle screw kits, Cement pusher (2021), 6 descendants of its own
- K212489: BonOs Inject Bone Cement; NEO Pedicle Screw System (2021), 5 descendants of its own
- K222256: BonOs® Inject Bone Cement; NEO Pedicle Screw System™ (2022), 3 descendants of its own
- K231809: Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement (2023), 1 descendant of its own
- K251719: Momentum® Posterior Spinal Fixation System (2025), 0 descendants of its own

## Indications for use
BonOs® Inject bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a vertebroplasty or balloon kyphoplasty procedure.

Source page: https://510kreport.com/device/K090460
Methodology: https://510kreport.com/methodology