# K180433: Ennovate®

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap Implant Systems, LLC
- Decided: Apr 26, 2018 after 65 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K003155 (2001). 375 ancestors in all.
1 later device descends 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)
- K162134: ENNOVATE Spinal System, Aesculap Implant Systems, LLC (2016) Summary page 4.

## Most influential descendants
- K210963: ENNOVATE Spinal System (2021), 0 descendants of its own

## Recalls of this device
- Jul 15, 2022 · Class II · Z-1638-2022: Potential for the incorrect screw to be included in the package.

## 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/K180433
Methodology: https://510kreport.com/methodology