# K213659: LigaPASS™ 2.0 Ligament Augmentation System

- Pathway: 510(k) (Traditional)
- Applicant: Medicrea International SA
- Decided: May 24, 2022 after 186 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: 10 generations back to K925812 (1993). 32 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173506: LigaPASS, Medicrea International SA (2018) Summary page 4.
- K172021: LigaPASS, Medicrea International SA (2017) Summary page 4.
- K112736: Pass LP Spinal, Medicrea International (2012) Summary page 4.

## Most influential descendants
- K253615: Invictus Bands System (2026), 0 descendants of its own
- K230565: HILINE™ Fixation System (2023), 0 descendants of its own

## 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, adults scoliosis and kyphosis; • Spine 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 implants made of titanium or cobalt-chrome alloy whenever "wiring" may help secure the attachment of other implants.

Source page: https://510kreport.com/device/K213659
Methodology: https://510kreport.com/methodology