# K162143: FixxSure® X-Link

- Pathway: 510(k) (Traditional)
- Applicant: Innovasis, Inc.
- Decided: Sep 23, 2016 after 53 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K990745 (1999). 75 ancestors in all.
No later device cites it as a predicate yet.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081331: Fixxsure Cross Link, Spineworks, LLC (2008) Summary page 6.
- K140238: Excella Iii-D Spinal Deformity System, Innovasis, Inc. (2014) Summary page 6.
- K032739: Ucr Spinal System, Seaspine (2003) Summary page 6.

## Indications for use
The SpineWorks™ FixxSure® X-Link is intended to work with the Innovasis® Excella® Spinal System to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: i) Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra; ii) Degenerative spondylolisthesis with objective evidence of neurologic impairment; iii) Fracture; iv) Dislocation; v) Scoliosis; vi) Kyphosis; vii) Spinal tumor; and viii) Previous failed fusion (pseudarthrosis). The SpineWorks™ FixxSure® X-Link can also be used with the Talon® Pedicle Screw System.*

Source page: https://510kreport.com/device/K162143
Methodology: https://510kreport.com/methodology