# K081331: Fixxsure Cross Link

- Pathway: 510(k) (Traditional)
- Applicant: Spineworks, LLC
- Decided: Jul 23, 2008 after 72 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: 7 generations back to K901587 (1990). 20 ancestors in all.
91 later devices descend from it; 2 cite it directly.
0 of 112 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032739: Ucr Spinal System, Seaspine (2003) Summary page 1.
- K071824: Acme Talon Pedicle Screw, Acme Spine, LLC (2007) Summary page 1.

## Most influential descendants
- K110692: Streamline TL Spinal System (2011), 89 descendants of its own
- K111502: Streamline TL Spinal System (2011), 88 descendants of its own
- K132049: Thunderbolt and Lancer  Pedicle Screw Systems (2014), 82 descendants of its own
- K160775: Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems (2016), 73 descendants of its own
- K181677: Kodiak Spinal Fixation System (2018), 70 descendants of its own

## Indications for use
The SpineWorks FixxSure Cross Link is intended work with the Talon Pedicle Screw system to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). The SpineWorks FixxSure Cross Link must be used with the Talon Pedicle Screw system.

Source page: https://510kreport.com/device/K081331
Methodology: https://510kreport.com/methodology