# K183080: Mega Plus Spine System

- Pathway: 510(k) (Special)
- Applicant: Bk Meditech, Co., Ltd.
- Decided: Dec 10, 2018 after 35 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: 16 generations back to K003155 (2001). 322 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 325 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173180: Mega Plus Spine System, Bk Meditech, Co., Ltd. (2018) Summary page 4.
- K111940: S 100 Pedicle Screw System, Renovis Surgical Technologies, LLC (2012) Summary page 5.
- K130176: Firebird Spinal Fixation System, Orthofix (2013) Summary page 5.
- K113666: Xia 3 Spinal System, Stryker Spine (2012) Summary page 5.

## Most influential descendants
- K200981: Mega Plus MIS Spine System (2020), 0 descendants of its own
- K191655: MEGAFIX® Pedicle Screw Spinal System (2020), 0 descendants of its own

## Indications for use
The Mega Plus Spine System is intended to provide 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 disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

Source page: https://510kreport.com/device/K183080
Methodology: https://510kreport.com/methodology