# K091717: Any Plus Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: GS Medical Co., Ltd.
- Decided: Jan 25, 2010 after 228 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: 4 generations back to K000319 (2000). 12 ancestors in all.
130 later devices descend from it; 8 cite it directly.
0 of 143 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053573: GSS Pedicle Screw System, GS Medical Co., Ltd. (2006) Summary page 1.
- K052123: Synthes Pangea System, Synthes (Usa) (2005) Summary page 1.
- K021564: Incompass Spinal Fixation System, Spinal Concepts, Inc. (2002) Summary page 1.

## Most influential descendants
- K120270: Venus Spinal Fixation System (2012), 111 descendants of its own
- K123549: Polaris Spinal System - Ballista II Percutaneous Screw Placement System (2013), 75 descendants of its own
- K131615: Polaris Spinal System (2013), 70 descendants of its own
- K133746: Polaris Spinal System (2014), 67 descendants of its own
- K143363: VENUS Spinal Fixation System (2015), 33 descendants of its own

## Indications for use
AnyPlus Spinal Fixation System are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1 -S2), a posterior hook fixation system (T 1-5), or as a anterolateral fixation system (T8-L_5). 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 of the following indications regardless of the 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/K091717
Methodology: https://510kreport.com/methodology