# K112551: S4 Spinal System

- Pathway: 510(k) (Special)
- Applicant: Aesculap Implant System, Inc.
- Decided: Nov 21, 2011 after 81 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: 8 generations back to K980447 (1998). 96 ancestors in all.
61 later devices descend from it; 4 cite it directly.
0 of 158 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100623: Aesculap Implant Systems S4 Spinal System, Aesculap Implant Systems (2010) Summary page 1.
- K071945: S4 Spinal System, Aesculap Implant Systems (2007) Summary page 1.
- K062085: S4 Spinal System, Aesculap (2007) Summary page 1.
- K032219: Revolution Spinal Fixation System, Spinal Innovations, Inc. (2003) Summary page 1.
- K001080: Spine System Evolution, Aesculap, Inc. (2000)

## Most influential descendants
- K123352: S4 Spinal System (2012), 51 descendants of its own
- K130291: S4 Spinal System (2013), 44 descendants of its own
- K182377: CarboClear® Pedicle Screw System (2018), 39 descendants of its own
- K190545: VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 (2019), 29 descendants of its own
- K190526: High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws (2019), 28 descendants of its own

## Indications for use
The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for treatment of the following acute and chronic instabilities or deformities: 1) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) 2) spondylolisthesis, 3) trauma (i.e., fracture or dislocation), 4) spinal stenosis, 5) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), 6) tumor, 7) pseudoarthrosis, and 8) failed previous fusion.

Source page: https://510kreport.com/device/K112551
Methodology: https://510kreport.com/methodology