# K161231: Facilis™ Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Baui Biotech Co., Ltd.
- Decided: Jan 23, 2017 after 266 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K981676 (1999). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981676: CD Horizon Spinal System, Sofamor Danek USA,Inc. (1999) Summary page 4.

## Most influential descendants
- K190600: ORION Spinal System (2020), 0 descendants of its own
- K191494: Facilis™ Spinal System (2019), 0 descendants of its own

## Indications for use
The FacilisTM Spinal System is a non-cervical, pedicle screw system intended to provide posterior, non-cervical immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). The FacilisTM Spinal System is also indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the implant fixed or attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

Source page: https://510kreport.com/device/K161231
Methodology: https://510kreport.com/methodology