# K173814: DeGen Medical E3 MIS Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Degen Medical
- Decided: Jan 29, 2018 after 45 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: 19 generations back to K003155 (2001). 445 ancestors in all.
No later device cites it as a predicate yet.
1 of 446 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172101: ROMEO® 2 Posterior Osteosynthesis System, Spineart (2017) Summary page 4.
- K142531: F1-Modular Pedicle Screw System, Degen Medical (2015) Summary page 4.
- K160926: F1 MPS Modular Pedicle Screw System, Degen Medical (2016) Summary page 4.
- K161363: Arsenal Spinal Fixation System, Alphatec Spine, Inc. (2016) Summary page 4.

## Indications for use
The DeGen Medical E3 MIS Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used for posterior noncervical pedicle screw fixation in pediatric patients, the DeGen Medical E3 MIS Pedicle Screw System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The DeGen Medical E3 MIS Pedicle Screw System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Source page: https://510kreport.com/device/K173814
Methodology: https://510kreport.com/methodology