# K123939: S4 Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap Implant Systems, Inc.
- Decided: Mar 12, 2013 after 82 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). 67 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002824: Macs Modular Anterior Construct System, Aesculap, Inc. (2001) Summary page 1.
- K032219: Revolution Spinal Fixation System, Spinal Innovations, Inc. (2003) Summary page 1.
- K100623: Aesculap Implant Systems S4 Spinal System, Aesculap Implant Systems (2010) Summary page 1.

## Most influential descendants
- K162134: ENNOVATE Spinal System (2016), 2 descendants of its own
- K180433: Ennovate® (2018), 1 descendant of its own
- K210963: ENNOVATE Spinal System (2021), 0 descendants of its own

## Indications for use
The 54 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and ion-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 wit 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/K123939
Methodology: https://510kreport.com/methodology