# K132395: Ligapass

- Pathway: 510(k) (Traditional)
- Applicant: Medicrea International
- Decided: Dec 6, 2013 after 127 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: 6 generations back to K925812 (1993). 27 ancestors in all.
23 later devices descend from it; 2 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110348: Universal Clamp Spinal Fixation System, Zimmer Spine (2011) Summary page 1.
- K112736: Pass LP Spinal, Medicrea International (2012) Summary page 1.

## Most influential descendants
- K160698: LigaPASS (2016), 12 descendants of its own
- K172021: LigaPASS (2017), 11 descendants of its own
- K143350: Nile Alternative Fixation (2015), 10 descendants of its own
- K173506: LigaPASS (2018), 9 descendants of its own
- K161332: NILE Proximal Fixation Spinal System (2017), 5 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. LigaPASS system is indicated for the following applications: -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 10 years of age and older, adult scoliosis, and kyphosis; -Spinal degenerative surgery, as an adjunct to spinal fusions;

Source page: https://510kreport.com/device/K132395
Methodology: https://510kreport.com/methodology