# K173506: LigaPASS

- Pathway: 510(k) (Traditional)
- Applicant: Medicrea International SA
- Decided: Apr 3, 2018 after 141 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: 9 generations back to K925812 (1993). 31 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172021: LigaPASS, Medicrea International SA (2017) Summary page 4.

## Most influential descendants
- K222097: OLYMPIC Deformity Band System (2023), 3 descendants of its own
- K231694: MASADA Modular Spinal Fixation System (2023), 2 descendants of its own
- K213659: LigaPASS™ 2.0 Ligament Augmentation System (2022), 2 descendants of its own
- K211057: LigaPASS® Spinal System, CD Horizon™ Spinal System (2021), 1 descendant of its own
- K261374: LigaPASS™ System (2026), 0 descendants of its own

## Indications for use
The LigaPASS is a temporary implant 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, used in sublaminar, or facet wiring techniques -Spinal reconstruction 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; The LigaPASS system may also be used in conjunction with other medical implant 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/K173506
Methodology: https://510kreport.com/methodology