# K083004: Mili (Minimally Invasive Lumbar Implant) System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap Implant Systems, Inc.
- Decided: Jul 2, 2009 after 267 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: 1 generation back to K013196 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032219: Revolution Spinal Fixation System, Spinal Innovations, Inc. (2003) Summary page 1.
- K013196: Ascend Spinal Fixation System with the Shadow Spinal System, Spinal Innovations, LLC (2002) Summary page 1.

## Indications for use
The MILl System is intended for posterior, non-cervical pedicle fixation of the spine. It is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of one or more of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolithesis (Grade 1/11) with objective evidence of neurological impairment, fracture, dislocation, scoliosis (one level), kyphosis, spinal tumor, failed previous fusion (pseudarthrosis), The MILl System, when used as a pedicle screw fixation system, is indicated for use in patients: a) who are receiving fusion using autogenous graft only; b) who are having the device fixed or attached to the thoracolumbar or sacral spine; and c) who are having the device removed after the development of a solid fusion mass. The MILl System is indicated only for one-level or adjacent two-level procedures.

Source page: https://510kreport.com/device/K083004
Methodology: https://510kreport.com/methodology