# K261374: LigaPASS™ System

- Pathway: 510(k) (Special)
- Applicant: Medicrea International S.A.S
- Decided: May 27, 2026 after 30 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: 21 generations back to K040583 (2004). 230 ancestors in all.
No later device cites it as a predicate yet.
0 of 231 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211057: LigaPASS® Spinal System, CD Horizon™ Spinal System, Medtronic, Inc. (2021) Summary page 5.
- K173506: LigaPASS, Medicrea International SA (2018) Summary page 5.

## Indications for use
The LigaPASS ™ System is an implant for use in orthopaedic 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 are as follows: - Spinal trauma surgery, used in sublaminar 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 and kyphosis, - Spinal degenerative surgery, as an adjunct to spinal fusions, - Intended for use with a posterior spinal instrumentation construct when ligament augmentation is needed. The LigaPASS ™ system may also be used in conjunction with other medical grade implants made of titanium or cobalt-chrome alloy whenever "wiring" may help secure the attachment of other implants.

Source page: https://510kreport.com/device/K261374
Methodology: https://510kreport.com/methodology