# K240350: AnyPlus II Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: GS Medical Co., Ltd.
- Decided: Apr 3, 2024 after 58 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: 6 generations back to K000319 (2000). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172546: AnyPlus® Spinal Fixation System, GS Medical Co., Ltd. (2017) Summary page 5.

## Indications for use
The GS Medical AnyPlus II Spinal Fixation System is composed of a non-cervical spinal fixation devices. It is intended for use as posterior pedicle screw fixation system (T1-S2), a posterior hook fixation system (T1-L5), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. System components are to be used for immobilization and stabilization of the spine as an adjunct to fusion. These devices are indicated for all following indications regardless of intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.

Source page: https://510kreport.com/device/K240350
Methodology: https://510kreport.com/methodology