# K200981: Mega Plus MIS Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Bk Meditech, Co., Ltd.
- Decided: Aug 11, 2020 after 119 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: 17 generations back to K003155 (2001). 405 ancestors in all.
No later device cites it as a predicate yet.
0 of 406 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183080: Mega Plus Spine System, Bk Meditech, Co., Ltd. (2018) Summary page 4.
- K151648: Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle Screw System, Valencia MIS Pedicle Screw System, Altus Partners, LLC (2015) Summary page 5.
- K171421: VERTICALE® Posterior Spinal Fixation System/VERTICALE® System, Silony Medical GmbH (2018) Summary page 5.
- K110280: Revlok Fenestrated Screw System, Globus Medical, Inc. (2011) Summary page 5.

## Indications for use
The Mega Plus MIS 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). The Mega Plus MIS Spine System can be used in an open approach and percutaneous approach.

Source page: https://510kreport.com/device/K200981
Methodology: https://510kreport.com/methodology