# K063067: Confidence Fenestrated Introducer Needle

- Pathway: 510(k) (Special)
- Applicant: Disc-O-Tech Medical Technologies, Ltd.
- Decided: Nov 3, 2006 after 28 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: 6 generations back to K002652 (2001). 7 ancestors in all.
4 later devices descend from it; 3 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)
- K060300: Confidence High Viscosity Bone Cement, Disc-O-Tech Medical Technologies, Ltd. (2006) Summary page 2.
- K062424: Confidence EX High Viscosity Bone Cement, Disc-O-Tech Medical Technologies, Ltd. (2006) Summary page 2.

## Most influential descendants
- K070351: Space 360 Delivery System (2007), 1 descendant of its own
- K130402: Spider System Kolibri Cement Needle (2013), 0 descendants 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
- K071375: Mesh Fenestrated Introducer Needle (Mesh Introducer Needle) (2007), 0 descendants of its own

## Indications for use
The Confidence Cement Delivery System is intended for percutaneous delivery of Confidence bone cement, which is indicated for fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).

Source page: https://510kreport.com/device/K063067
Methodology: https://510kreport.com/methodology