# K123352: S4 Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap Implant Systems, Inc.
- Decided: Dec 12, 2012 after 42 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: 11 generations back to K853033 (1985). 130 ancestors in all.
51 later devices descend from it; 6 cite it directly.
0 of 182 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112551: S4 Spinal System, Aesculap Implant System, Inc. (2011) Summary page 1.
- K062085: S4 Spinal System, Aesculap (2007) Summary page 1.
- K001080: Spine System Evolution, Aesculap, Inc. (2000)
- K033901: Merlin Spine System, Depuy Spine, Inc. (2004) Summary page 1.
- K063156: Modification to Expedium Spine System, Depuy Spine, Inc. (2006) Summary page 1.
- K073126: Expedium Spine System, Depuy Spine, Inc. (2007) Summary page 1.
- K073364: Expedium 4.5MM Spine System, Depuy Spine, Inc. (2008) Summary page 1.
- K081898: Expedium Spine System, Depuy Spine, Inc. (2008) Summary page 1.

## Most influential descendants
- 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
- K200596: G21 Cement, VADER® Pedicle System (2020), 27 descendants of its own

## Indications for use
The S4 Spinal System is intended for anterior/antera lateral and posterior, nan-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mnature patients and is intended to be used as ah 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) spondytolisthesis, 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/K123352
Methodology: https://510kreport.com/methodology