# K230565: HILINE™ Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Apr 20, 2023 after 50 days
- Product code: OWI (Bone Fixation Cerclage, Sublaminar)
- Device class: 2
- Regulation: 21 CFR 888.3010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K040583 (2004). 181 ancestors in all.
No later device cites it as a predicate yet.
0 of 182 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133482: Silc Fixation System, Globus Medical, Inc. (2014) Summary page 4.
- K172417: SILC® Fixation System, Globus Medical, Inc. (2017) Summary page 4.
- K153348: Jazz Lock, Implanet, S.A. (2016) Summary page 4.
- K182771: ISS-JAZZ Screw System and JAZZ CAP SP, Implanet, S.A. (2019) Summary page 4.
- K213659: LigaPASS™ 2.0 Ligament Augmentation System, Medicrea International SA (2022) Summary page 4.

## Indications for use
The HILINE™ Fixation System consists of temporary implants for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques; Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis; Spinal degenerative surgery, as an adjunct to spinal fusions; Use with a posterior spinal instrumentation construct when ligament augmentation is needed. The HILINE™ Fixation System may also be used in conjunction with other medical implants made of similar metals whenever “wiring” may help secure the attachment of other implants.

Source page: https://510kreport.com/device/K230565
Methodology: https://510kreport.com/methodology