# K070351: Space 360 Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Dfine, Inc.
- Decided: Jun 29, 2007 after 143 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: 7 generations back to K002652 (2001). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040483: Equestra Fluid Delivery System, Medtronic Sofamor Danek, Inc. (2004) Summary page 1.
- K063067: Confidence Fenestrated Introducer Needle, Disc-O-Tech Medical Technologies, Ltd. (2006) Summary page 1.
- K040338: Arthrocare Controller, Cable, Foot Control, Power Cord, Wands, Models H0970-02, H2000-04, H2000-05, H0970-06, Arthrocare Corp. (2004) Summary page 1.
- (no number) Disc-C-Tech Cementer Injector: named in the summary without a submission number

## Most influential descendants
- 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 SPACE 360 Delivery System is intended for percutaneous delivery of SPACE CpsXL 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/K070351
Methodology: https://510kreport.com/methodology