# K191655: MEGAFIX® Pedicle Screw Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Seohancare Co., Ltd.
- Decided: Mar 6, 2020 after 259 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). 381 ancestors in all.
No later device cites it as a predicate yet.
1 of 382 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131878: Lliad, Kora, Zenius Pedicle Screw System, Medyssey USA, Inc. (2013) Summary page 5.
- K111362: Rexious Spinal Fixation System, Dio Medical Co., Ltd. (2011) Summary page 5.
- K183080: Mega Plus Spine System, Bk Meditech, Co., Ltd. (2018) Summary page 5.
- K123164: Spinefrontier Pedfuse Pedicle Screw System, Spinefrontier, Inc. (2013) Summary page 5.
- K141282: PGS 5.5 MM Cannulated Pedicle Screw, Pinnacle Spine Group (2014) Summary page 5.

## Indications for use
The MEGAFIX(R) Pedicle Screw Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft or allograft. This system is intended for posterior, non-cervical pedicle fixation of the lumbar and sacral spine for following indications: Degenerative Disc Disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis (Grade 1 and 2) of the L5-S1; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Source page: https://510kreport.com/device/K191655
Methodology: https://510kreport.com/methodology