# K062424: Confidence EX High Viscosity Bone Cement

- Pathway: 510(k) (Special)
- Applicant: Disc-O-Tech Medical Technologies, Ltd.
- Decided: Sep 14, 2006 after 27 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: 5 generations back to K002652 (2001). 6 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 14 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.

## Most influential descendants
- K063067: Confidence Fenestrated Introducer Needle (2006), 4 descendants of its own
- K070351: Space 360 Delivery System (2007), 1 descendant of its own
- K070527: Arcuate Vertebral Augmentation System (2007), 1 descendant of its own
- K130402: Spider System Kolibri Cement Needle (2013), 0 descendants of its own
- K113452: Acu-Cut Vertebral Augmentation System (2012), 0 descendants of its own

## Indications for use
The Disc-O-Tech Confidence EX High Viscosity Bone Cement is indicated for the 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/K062424
Methodology: https://510kreport.com/methodology