# K162134: ENNOVATE Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap Implant Systems, LLC
- Decided: Dec 14, 2016 after 135 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: 18 generations back to K003155 (2001). 374 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 377 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130291: S4 Spinal System, Aesculap Implant System, Inc. (2013) Summary page 4.
- K123939: S4 Spinal System, Aesculap Implant Systems, Inc. (2013) Summary page 4.
- K123352: S4 Spinal System, Aesculap Implant Systems, Inc. (2012) Summary page 4.
- K112551: S4 Spinal System, Aesculap Implant System, Inc. (2011) Summary page 4.
- K100623: Aesculap Implant Systems S4 Spinal System, Aesculap Implant Systems (2010) Summary page 4.
- K090657: Modification to: S4 Spinal System, Aesculap Implant Systems (2009) Summary page 4.
- K071945: S4 Spinal System, Aesculap Implant Systems (2007) Summary page 4.
- K062085: S4 Spinal System, Aesculap (2007) Summary page 4.
- K032219: Revolution Spinal Fixation System, Spinal Innovations, Inc. (2003) Summary page 4.
- K090230: Expedium Spine System, Depuy Spine, Inc. (2009) Summary page 4.
- K082942: Modfication to: Expedium Spine System, Depuy Spine, Inc. (2008) Summary page 4.
- K041119: Expedium Spine System, Depuy Spine, Inc. (2004) Summary page 4.
- K073364: Expedium 4.5MM Spine System, Depuy Spine, Inc. (2008) Summary page 4.
- K070300: Expedium SFX Cross Connector System, Depuy Spine, Inc. (2007) Summary page 4.
- K151974: Polaris Spinal System, Biomet Spine (2015) Summary page 4.
- K133746: Polaris Spinal System, Biomet Spine (Aka Ebi, LLC) (2014) Summary page 4.
- K123549: Polaris Spinal System - Ballista II Percutaneous Screw Placement System, Biomet Spine (Aka Ebi, LLC) (2013) Summary page 4.
- K090203: 5.5 Helical Flange Spinal System, Polaris Components, Ebi, L.P. (2009) Summary page 4.
- K111957: Polaris Spinal System, Biomet Spine (Ebi, LLC) (2011) Summary page 4.

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

## Indications for use
The ENNOVATE 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 ENNOVATE System can be used in both an Open and Minimally Invasive Surgery (MIS). 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/K162134
Methodology: https://510kreport.com/methodology