# K130402: Spider System Kolibri Cement Needle

- Pathway: 510(k) (Special)
- Applicant: Sintea Plustek, LLC
- Decided: Apr 1, 2013 after 41 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). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072198: X-Void, Spider, Sintea Biotech, Inc. (2008) Summary page 1.
- K072133: Avaflex Vertebral Augmentation Needle, Cardinal Health, Inc. (2007) Summary page 1.
- K063067: Confidence Fenestrated Introducer Needle, Disc-O-Tech Medical Technologies, Ltd. (2006) Summary page 1.

## Indications for use
The Spider System Kolibri Cement Needle is intended to be used as a system for the creation of a cavity in cancellous bone in the spine, in order to treat pathological compression fractures that may result from osteoporosis, benign lesions, and/or malignant lesions. This system is to be used with an already FDA cleared PMMA bone cement.

Source page: https://510kreport.com/device/K130402
Methodology: https://510kreport.com/methodology