# K090986: Stabili Erx Bone Cement, Model 1135,Stabilit Vertebral Augmentation System (for Use W/ Stabilit Erx Bone Cement)

- Pathway: 510(k) (Traditional)
- Applicant: Dfine, Inc.
- Decided: Dec 30, 2009 after 267 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: 8 generations back to K002652 (2001). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072496: Modification to Space Cpsxl Bone Cement, Dfine, Inc. (2007) Summary page 2.
- K070351: Space 360 Delivery System, Dfine, Inc. (2007) Summary page 2.

## Indications for use
The StabiliT ERx Bone Cement is intended for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). The StabiliT Vertebral Augmentation System is intended for percutaneous delivery of StabiliT ERx Bone Cement in vertebroplasty or kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Source page: https://510kreport.com/device/K090986
Methodology: https://510kreport.com/methodology