# K072198: X-Void, Spider

- Pathway: 510(k) (Traditional)
- Applicant: Sintea Biotech, Inc.
- Decided: Jun 6, 2008 after 304 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K981251 (1998). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041454: Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A, Kyphon, Inc. (2004) Summary page 2.

## Most influential descendants
- K130402: Spider System Kolibri Cement Needle (2013), 0 descendants of its own

## Indications for use
The SPIDERTM 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/K072198
Methodology: https://510kreport.com/methodology