# K073517: H-Link Integrated Rod

- Pathway: 510(k) (Special)
- Applicant: Globus Medical, Inc.
- Decided: Jan 3, 2008 after 20 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- 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: 5 generations back to K990745 (1999). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061202: Revere Stabilization System, Globus Medical, Inc. (2006) Summary page 1.
- K040442: Protex Stabilization System, Globus Medical, Inc. (2004) Summary page 1.
- K052069: Protex Stabilization System with Additional Componentes, Globus Medical, Inc. (2005) Summary page 1.

## Indications for use
The H-LINKTM Integrated Rod, when used with a posterior pedicle screw system, is intended 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 the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion. In addition, the H-LINKTM Integrated Rod is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

Source page: https://510kreport.com/device/K073517
Methodology: https://510kreport.com/methodology