510(k) Report

510(k) · Cleared

Cleared

Endius Minit Posterior Cervical and Upper Thoracic Fixation System

K060683510(k) TraditionalCleared Apr 18, 200634-day reviewClass II21 CFR 888.3050

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

Endius, Inc. · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Apr 18, 2006 as substantially equivalent to K052180 (Medtronic Sofamor Danek, 2005) and 2 other predicates after a 34-day review. Its family tree reaches back 3 generations to 2001. 32 later devices descend from it.

Decided
Apr 18, 2006
Review
34 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K003780 (2001). 6 ancestors in all, the oldest K991089 (1999). 32 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1999: 1 other ancestor2004: 1 other ancestor2007: 1 descendant cleared2015: 3 descendants cleared2008: 2 descendants cleared2014: 1 descendant cleared2018: 2 descendants cleared2017: 3 descendants cleared2016: 4 descendants cleared2020: 3 descendants cleared2022: 2 descendants cleared2021: 1 descendant cleared2019: 1 descendant cleared2024: 3 descendants cleared2023: 2 descendants cleared2026: 4 descendants clearedK003780 · Vertex Reconstruction System · Medtronic Sofamor Danek, Inc. · 2001K042498 · Vertex Reconstruction System · Medtronic Sofamor Danek · 2004 · recalledK052180 · Modification to Vertex Reconstruction System · Medtronic Sofamor Danek · 20051995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 4 descendants4 generations forward: 9 descendants5 generations forward: 8 descendants6 generations forward: 4 descendants7 generations forward: 2 descendants K052180 · Modification to Vertex Reconstruction System · Medtronic Sofamor Danek · 2005K042498 · Vertex Reconstruction System · Medtronic Sofamor Danek · 2004 · recalledK003780 · Vertex Reconstruction System · Medtronic Sofamor Danek, Inc. · 20010+5
  1. Root · 3 generations backK003780 Vertex Reconstruction SystemMedtronic Sofamor Danek, Inc. · 2001
  2. 2 generations backK042498 Vertex Reconstruction SystemMedtronic Sofamor Danek · 2004 · Recalled
  3. 1 generation backK052180 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2005
  4. This deviceK060683 Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc. · 2006
  5. Descendant · cites it directly · 31 of its ownK070282 Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc. · 2007
  6. Descendant · 2 generations on · 27 of its ownK133556 Virage Oct Spinal Fixation SystemZimmer Spine, Inc. · 2014 · Recalled
  7. Descendant · 3 generations on · 13 of its ownK171444 YUKON OCT Spinal SystemK2m, Inc. · 2017 · Recalled
  8. Descendant · 3 generations on · 13 of its ownK150918 PASS OCT Spinal SystemMedicrea International SA · 2015
  9. Descendant · 3 generations on · 5 of its ownK182182 YUKON OCT Spinal SystemK2m · 2018

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2007: 12008: 22014: 12015: 32016: 42017: 32018: 22019: 12020: 32021: 12022: 22023: 22024: 32026: 4
2007high 4 (2016) · low 0 (2009)2026

Most influential descendants

Showing 5 of 32 · See all
  • K070282Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc. · 2007 · cites it directly31descendants
  • K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc. · 2014 · 2 generations on27descendants
  • K171444YUKON OCT Spinal SystemK2m, Inc. · 2017 · 3 generations on13descendants
  • K150918PASS OCT Spinal SystemMedicrea International SA · 2015 · 3 generations on13descendants
  • K182182YUKON OCT Spinal SystemK2m · 2018 · 3 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K003780Vertex Reconstruction SystemMedtronic Sofamor Danek, Inc.2001—
−2K042498Vertex Reconstruction SystemMedtronic Sofamor Danek20041
−1K052180Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2005—
0 (this device)K060683Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc.2006—
+1K070282Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc.2007—
+2K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.20142
+3K171444YUKON OCT Spinal SystemK2m, Inc.20173
+3K150918PASS OCT Spinal SystemMedicrea International SA2015—
+3K182182YUKON OCT Spinal SystemK2m2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200010
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200820
201410
201530
201640
201730
201820
201910
202030
202110
202220
202320
202430
202640
FIG. 1 — Lineage of K060683, 2001–2026Source: 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 KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against? (4)

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
*K052180Modification to Vertex Reconstruction System
Summary page 2
…t Notification Endius Minit PCT System March 14, 2006 5.5 Predicate Devices Device Name(s) & 510(k) Number: * Medtronic Sofamor Danek VERTEX Reconstruction System, K052180 * Synthes Spine Cervifix (K991089, KO01864) and Starlock Systems 5.6 Device Description The Endius Minit Posterior Cervical…
Medtronic Sofamor Danek2005—
*K991089Synthes Cervifix System
Summary page 2
…m March 14, 2006 5.5 Predicate Devices Device Name(s) & 510(k) Number: * Medtronic Sofamor Danek VERTEX Reconstruction System, K052180 * Synthes Spine Cervifix (K991089, KO01864) and Starlock Systems 5.6 Device Description The Endius Minit Posterior Cervical and Upper Thoracic Fixation System is…
Synthes Spine1999—
*K001864Synthes Cervifix SystemSynthes Spine2000—
*—Synthes Spine Starlock Systems
Named without a submission number
—

Also cleared against K052180: 3 other devices →

What descends from it? (32)

See all 32

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K070282Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc.200731
K142752Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System…Zimmer Spine, Inc.20150

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?

  • The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 11 months on median.
  • 1 of the 6 ancestors has a recall of any class.
  • Of its descendants, K070282 (Endius, Inc., 2007) has gone furthest, with 31 descendants of its own.
  • 3 other devices also cite its predicate K052180.

How does its category compare?

All KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWP

9in 2015

2007: 142008: 132009: 122010: 142011: 122012: 182013: 122014: 132015: 9
2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007: 96 days median2008: 50 days median2009: 89 days median2010: 186 days median2011: 67 days median2012: 112 days median2013: 99 days median2014: 138 days median2015: 113 days median
2007high 186 (2010) · low 50 (2008)2026

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

Recalls per year · KWP

2in 2022

2007: 22008: 12009: 232010: 22011: 62012: 12013: 32015: 12016: 32018: 12019: 22022: 2
2007high 23 (2009) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWP

494in 2025

2007: 2102008: 5942009: 6822010: 4742011: 7922012: 9182013: 1,0902014: 1,0222015: 1,3482016: 1,3792017: 8642018: 6572019: 5182020: 7962021: 5252022: 3352023: 3322024: 4362025: 494
2007high 1,379 (2016) · low 210 (2007)2025

MAUDE reports naming product code KWP, 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
200714962210
200813501594
2009128923682
2010141862474
201112676792
2012181121918
2013129931,090
20141313801,022
2015911311,348
20160—31,379
20170—0864
20180—1657
20190—2518
20200—0796
20210—0525
20220—2335
20230—0332
20240—0436
20250—0494
20260—0—

What is it indicated for?

When intended to promote fusion of the cervical spine and the thoracic spine, (C1 -T3), the Endius Minit Posterior Cervical and Upper Thoracic Fixation System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. Hooks and Rods The hooks and rods are also intended to…

Read the full statement (114 words)

When intended to promote fusion of the cervical spine and the thoracic spine, (C1 -T3), the Endius Minit Posterior Cervical and Upper Thoracic Fixation System is indicated for the following:

DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Hooks and Rods

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-'1'3) spine.

Screws/Connectors

The use of screws is limited to placement in the TI -T3 in treating thoracic conditions only.

Screws arc not intended to be placed in the cervical spine.

Indications for use as stated in the FDA summary.

Also cleared against K052180

3 other devices cite the same predicate.

  • K071905Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC · 2007
  • K062934SierraSeaspine, Inc. · 2006
  • K052734Modification to: Vertex Reconstruction SystemMedtronic Sofamor Danek · 2005

More from Endius, Inc.

33 FDA decisions under this applicant name. See the company

  • K080258Modification to Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc. · 2008
  • K073510Endius Title 2 Poly Axial Spinal SystemEndius, Inc. · 2008
  • K073267Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc. · 2008
  • K072840Endius Title 2 Polyaxial Spinal SystemEndius, Inc. · 2007
  • K070282Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc. · 2007

Recent decisions in KWP

The KWP category page

  • K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2015
  • K150753OASYS SystemStryker Corporation · 2015
  • K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc. · 2015
  • K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
  • K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 20153 recalls

https://510kreport.com/device/K060683 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060683: Endius Minit Posterior Cervical and Upper Thoracic Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060683

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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