# K061531: Space Cpsxl Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: Dfine, Inc.
- Decided: Aug 30, 2006 after 89 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: 4 generations back to K002652 (2001). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042415: Mendec Spine, Tecres S.P.A. (2005) Summary page 1.

## Most influential descendants
- K072496: Modification to Space Cpsxl Bone Cement (2007), 1 descendant of its own
- K090986: Stabili Erx Bone Cement, Model 1135,Stabilit Vertebral Augmentation System (for Use W/ Stabilit Erx Bone Cement) (2009), 0 descendants of its own

## Indications for use
The DFine SPACE CpsXL Bone Cement is indicated 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).

Source page: https://510kreport.com/device/K061531
Methodology: https://510kreport.com/methodology