# K202458: BonOs Inject, Pedicle screw kits, Cement pusher

- Pathway: 510(k) (Traditional)
- Applicant: Osartis GmbH
- Decided: May 18, 2021 after 264 days
- Product code: LOD (Bone Cement)
- 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: 19 generations back to K040583 (2004). 179 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 186 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152604: KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set, Medtronic Sofamor Danek USA, Incorporated (2016) Summary page 6.
- K170347: CD HORIZON™ Fenestrated Screw Set, Medtronic Sofamor Danek USA (2017) Summary page 6.
- K191148: Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set, Medtronic Sofamor Danek USA, Inc. (2019) Summary page 6.
- K090460: Bonos Inject, Aap Biomaterials GmbH (2009) Summary page 6.

## Most influential descendants
- 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
- K243693: NEO Pedicle Screw System™ (2024), 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 vertebroplasty or balloon kyphoplasty procedure. When used in conjunction with NEO Pedicle Screw System™ BonOs® Inject is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised. The NEO Pedicle Screw System™, when used as a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The system is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, tumor, pseudarthrosis, and/or failed previous fusion. When used in conjunction with BonOs® Inject Cement, the NEO Pedicle Screw System™ is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

Source page: https://510kreport.com/device/K202458
Methodology: https://510kreport.com/methodology