# K112736: Pass LP Spinal

- Pathway: 510(k) (Traditional)
- Applicant: Medicrea International
- Decided: Feb 1, 2012 after 134 days
- Product code: JDQ (Cerclage, Fixation)
- 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: 3 generations back to K925812 (1993). 3 ancestors in all.
25 later devices descend from it; 4 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060009: Abbott Spine Universal Clamp System, Abbott Spine, Inc. (2006) Summary page 1.

## Most influential descendants
- K132395: Ligapass (2013), 23 descendants of its own
- K160698: LigaPASS (2016), 12 descendants of its own
- K172021: LigaPASS (2017), 11 descendants of its own
- K133482: Silc Fixation System (2014), 11 descendants of its own
- K143350: Nile Alternative Fixation (2015), 10 descendants of its own

## Indications for use
The LigaPASS is a temporary implant for use in orthopedic surgery on skeletally mature patients. 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 scoliosis, kyphosis, spondylolisthesis; *Spinal degenerative surgery, as an adjunct to spinal fusions; The LigaPASS 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/K112736
Methodology: https://510kreport.com/methodology