# K071375: Mesh Fenestrated Introducer Needle (Mesh Introducer Needle)

- Pathway: 510(k) (Traditional)
- Applicant: Disc-O-Tech Medical Technologies, Ltd.
- Decided: Dec 21, 2007 after 219 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). 11 ancestors in all.
No later device cites it as a predicate yet.
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.
- K063067: Confidence Fenestrated Introducer Needle, Disc-O-Tech Medical Technologies, Ltd. (2006) Summary page 2.
- K041713: Super Revo Herculine Suture Anchor, Linvatec Corp. (2004) Summary page 2.
- K033654: Force Fiber, Teleflex Medical (2004) Summary page 2.

## Indications for use
The Mesh Introducer Needle is indicated for use in combination with the Confidence Bone Cement Delivery System. The Confidence Bone Cement Delivery System is intended for percutaneous delivery of Confidence Bone Cements, which are indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures.

Source page: https://510kreport.com/device/K071375
Methodology: https://510kreport.com/methodology