510(k) Report

510(k) · Cleared

Cleared

Mili (Minimally Invasive Lumbar Implant) System

K083004510(k) TraditionalCleared Jul 2, 2009267-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Aesculap Implant Systems, Inc. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Jul 2, 2009 as substantially equivalent to K032219 (Spinal Innovations, Inc., 2003) and 1 other predicate after a 267-day review. Its family tree reaches back 1 generation to 2002.

Decided
Jul 2, 2009
Review
267 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K013196 (2002). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 1 other ancestorK013196 · Ascend Spinal Fixation System with the Shadow Spinal System · Spinal Innovations, LLC · 2002200020022004200620082010
Other ancestors, by generation 1 generation back: 1 other ancestor K013196 · Ascend Spinal Fixation System with the Shadow Spinal System · Spinal Innovations, LLC · 20020
  1. Root · 1 generation backK013196 Ascend Spinal Fixation System with the Shadow Spinal SystemSpinal Innovations, LLC · 2002
  2. This deviceK083004 Mili (Minimally Invasive Lumbar Implant) SystemAesculap Implant Systems, Inc. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K013196Ascend Spinal Fixation System with the Shadow Spinal SystemSpinal Innovations, LLC2002—
0 (this device)K083004Mili (Minimally Invasive Lumbar Implant) SystemAesculap Implant Systems, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310
FIG. 1 — Lineage of K083004, 2002–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new NKB device

  1. #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K032219Revolution Spinal Fixation System
Summary page 1
…AL EQUIVALENCE Aesculap Implant Systems (AIS), Inc., believes that the MILl System is substantially equivalent to the S4 Lumbar Spinal System (also known as Revolution) (K032219), and the Ascend Spinal Fixation System with the Shadow Spinal System (K013196). DEVICE DESCRIPTION The Aesculap Implant Systems…
Spinal Innovations, Inc.2003—
*K013196Ascend Spinal Fixation System with the Shadow Spinal System
Summary page 1
…tem is substantially equivalent to the S4 Lumbar Spinal System (also known as Revolution) (K032219), and the Ascend Spinal Fixation System with the Shadow Spinal System (K013196). DEVICE DESCRIPTION The Aesculap Implant Systems (AIS) MILl System is a minimally invasive posterior plating system for the tho…
Spinal Innovations, LLC2002—

Also cleared against K032219: 8 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 2 ancestors has a recall.
  • 8 other devices also cite its predicate K032219.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007: 382008: 362009: 442010: 372011: 482012: 602013: 352014: 462015: 552016: 502017: 632018: 562019: 392020: 482021: 322022: 342023: 442024: 392025: 242026 (partial year): 30
2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007: 87 days median2008: 59 days median2009: 71 days median2010: 111 days median2011: 84 days median2012: 79 days median2013: 73 days median2014: 90 days median2015: 90 days median2016: 84 days median2017: 69 days median2018: 61 days median2019: 84 days median2020: 68 days median2021: 61 days median2022: 88 days median2023: 72 days median2024: 57 days median2025: 61 days median2026 (partial year): 91 days median
2007high 111 (2010) · low 57 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NKB

1in 2025

2007: 42008: 52009: 332010: 42011: 32012: 132014: 3, 1 Class I2015: 32016: 12017: 12018: 32019: 12020: 12022: 52023: 22024: 32025: 12026 (partial year): 3
2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007: 342008: 822009: 1712010: 4622011: 5772012: 1,7472013: 1,9622014: 1,6712015: 1,4462016: 1,5852017: 1,6182018: 1,6842019: 1,9152020: 2,0762021: 1,7452022: 1,3392023: 9192024: 1,6142025: 1,171
2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20073887434
20083659582
2009447133171
2010371114462
201148843577
20126079131,747
2013357301,962
201446903 (1)1,671
2015559031,446
2016508411,585
2017636911,618
2018566131,684
2019398411,915
2020486812,076
2021326101,745
2022348851,339
202344722919
2024395731,614
2025246111,171
202630913—

What is it indicated for?

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…

Read the full statement (172 words)

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.

Indications for use as stated in the FDA summary.

Also cleared against K032219

8 other devices cite the same predicate.

  • K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC · 2016
  • K123939S4 Spinal SystemAesculap Implant Systems, Inc. · 2013
  • K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd. · 2013
  • K112551S4 Spinal SystemAesculap Implant System, Inc. · 2011
  • K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems · 20101 recall
  • K090657Modification to: S4 Spinal SystemAesculap Implant Systems · 2009

More from Aesculap Implant Systems, Inc.

22 FDA decisions under this applicant name. See the company

  • K153629ArcadiusXP C Spinal SystemAesculap Implant Systems, Inc. · 2016
  • K132421Aesculap Peek XP Spinal Implant SystemAesculap Implant Systems, Inc. · 2014
  • K123939S4 Spinal SystemAesculap Implant Systems, Inc. · 2013
  • K123352S4 Spinal SystemAesculap Implant Systems, Inc. · 2012
  • K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011

Recent decisions in NKB

The NKB category page

  • K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. · 2026
  • K263062NOVIX Pedicle Screw SystemTdm Co., Ltd. · 2026
  • K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
  • K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc. · 2026
  • K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026

https://510kreport.com/device/K083004 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083004: Mili (Minimally Invasive Lumbar Implant) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083004

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026