# K210963: ENNOVATE Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap Implant Systems, LLC
- Decided: Jul 19, 2021 after 110 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: 21 generations back to K853033 (1985). 516 ancestors in all.
No later device cites it as a predicate yet.
1 of 517 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.
- K180433: Ennovate®, Aesculap Implant Systems, LLC (2018) Summary page 4.
- K151727: Everest Spinal System, K2m, Inc. (2015) Summary page 4.
- K130877: Expedium Spine System, Medos International SARL (2013) Summary page 4.
- K151974: Polaris Spinal System, Biomet Spine (2015) Summary page 4.

## 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/K210963
Methodology: https://510kreport.com/methodology