# K072282: Capless LI Pedicle Screw System

- Pathway: 510(k) (Special)
- Applicant: X-Spine Systems, Inc.
- Decided: Sep 14, 2007 after 29 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 4 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K081978: Reliance Spinal Screw System (2009), 8 descendants of its own
- K101112: Reliance Spinal Screw System (2010), 7 descendants of its own
- K090224: Fortex Pedicle Screw System (2009), 7 descendants of its own
- K123521: Reliance Spinal Screw System (2013), 5 descendants of its own
- K110896: Reliance Spinal Screw System (2012), 5 descendants of its own

## Recalls of this device
- Mar 24, 2009 · Not classified · Z-1694-2009: A defect cause was discovered following a customer complaint pertaining to a post operative dissociation of the Capless Li Screw construct. The screw assembly is made up of three parts; a cup which lo

Source page: https://510kreport.com/device/K072282
Methodology: https://510kreport.com/methodology