510(k) Report

510(k) · Cleared

Recalled · 2005

Spinal Concepts Inc. Nex-Link Spinal Fixation System

K031985510(k) TraditionalCleared Sep 11, 200376-day reviewClass II21 CFR 888.3070Recalls 4

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

Spinal Concepts, Inc. · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Sep 11, 2003 after a 76-day review. The FDA summary names its predicate without a number. 75 later devices descend from it. It has been recalled 4 times.

Decided
Sep 11, 2003
Review
76 days
Class
Class II
Product code
MNI
Recalls
4
Predicates
0

75 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 2005: 2 descendants cleared2006: 4 descendants cleared2011: 2 descendants cleared2012: 4 descendants cleared2015: 4 descendants cleared2014: 3 descendants cleared2018: 4 descendants cleared2016: 6 descendants cleared2013: 3 descendants cleared2007: 1 descendant cleared2023: 7 descendants cleared2020: 9 descendants cleared2017: 3 descendants cleared2022: 5 descendants cleared2021: 3 descendants cleared2019: 2 descendants cleared2026: 8 descendants cleared2024: 4 descendants cleared2025: 1 descendant cleared200020052010201520202025
  1. This deviceK031985 Spinal Concepts Inc. Nex-Link Spinal Fixation SystemSpinal Concepts, Inc. · 2003
  2. Descendant · cites it directly · 67 of its ownK050979 S4 Spinal SystemAesculap, Inc. · 2005
  3. Descendant · 2 generations on · 32 of its ownK060152 Modification to S4 Spinal SystemAesculap, Inc. · 2006
  4. Descendant · cites it directly · 16 of its ownK103414 Venus Cervical Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2011
  5. Descendant · cites it directly · 15 of its ownK120879 Lexus Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2012
  6. Descendant · 2 generations on · 15 of its ownK110197 Exactech Gibralt Spinal SystemExactech, Inc. · 2011 · Recalled

Showing 5 of 75 descendants. See all descendants

Descendants cleared per year

2005: 22006: 42007: 12011: 22012: 42013: 32014: 32015: 42016: 62017: 32018: 42019: 22020: 92021: 32022: 52023: 72024: 42025: 12026: 8
2005high 9 (2020) · low 0 (2008)2026

Most influential descendants

Showing 5 of 75 · See all
  • K050979S4 Spinal SystemAesculap, Inc. · 2005 · cites it directly67descendants
  • K060152Modification to S4 Spinal SystemAesculap, Inc. · 2006 · 2 generations on32descendants
  • K103414Venus Cervical Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2011 · cites it directly16descendants
  • K120879Lexus Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2012 · cites it directly15descendants
  • K110197Exactech Gibralt Spinal SystemExactech, Inc. · 2011 · 2 generations on15descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K031985Spinal Concepts Inc. Nex-Link Spinal Fixation SystemSpinal Concepts, Inc.2003—
+1K050979S4 Spinal SystemAesculap, Inc.2005—
+2K060152Modification to S4 Spinal SystemAesculap, Inc.2006—
+1K103414Venus Cervical Spinal Fixation SystemL&K BIOMED Co., Ltd.2011—
+1K120879Lexus Cervical Fixation SystemL&K BIOMED Co., Ltd.2012—
+2K110197Exactech Gibralt Spinal SystemExactech, Inc.20111

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200520
200640
200710
201120
201240
201330
201430
201540
201660
201730
201840
201920
202090
202130
202250
202370
202440
202510
202680
FIG. 1 — Lineage of K031985, 2003–2026Source: 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 MNI? 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
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What was it cleared against? (1)

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
*—Medtronic Sofamor Danek VERTEX Reconstruction System
Named without a submission number
—

What descends from it? (75)

See all 75

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

NumberDeviceApplicantDecidedDescendants
K050979S4 Spinal SystemAesculap, Inc.200567
K103414Venus Cervical Spinal Fixation SystemL&K BIOMED Co., Ltd.201116
K120879Lexus Cervical Fixation SystemL&K BIOMED Co., Ltd.201215
K052566Nex-Link Spinal Fixation System Open Polyaxial Screws, Models 2112, 2113, 2118, 2119…Abbott Spine, Inc.20064
K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143
K062505Nex-Link Spinal Fixation System Offset Connectors, 2121-XX SeriesAbbott Spine, Inc.20063
K113346Neon SystemUlrich GmbH & Co. KG20121
K052247Nex-Link Spinal Fixation System Variable Crosslink, Model 721-XXAbbott Spine, Inc.20051
K142752Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System…Zimmer Spine, Inc.20150
K121136Renoir Posterior Cervial Fixation SystemAccel Spine20120

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

Recalls of this device

DateClassRecallRoot causeReason
Dec 1, 2005Not classifiedZ-0605-2011Device DesignThe devices may fracture, resulting in surgical delay or the need for intervention to remove fragments from the surgical site.
Dec 1, 2005Not classifiedZ-0602-2011Device DesignThe devices may fracture, resulting in surgical delay or the need for intervention to remove fragments from the surgical site.
Dec 1, 2005Not classifiedZ-0603-2011Device DesignThe devices may fracture, resulting in surgical delay or the need for intervention to remove fragments from the surgical site.
Dec 1, 2005Not classifiedZ-0604-2011Device DesignThe devices may fracture, resulting in surgical delay or the need for intervention to remove fragments from the surgical site.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K050979 (Aesculap, Inc., 2005) has gone furthest, with 67 descendants of its own.

How does its category compare?

All MNI devices

MNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MNI

1in 2017

2007: 202008: 232009: 182010: 162011: 172012: 192013: 142014: 62015: 122016: 72017: 1
2007high 23 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNI

168in 2016

2007: 82 days median2008: 64 days median2009: 86 days median2010: 74 days median2011: 111 days median2012: 75 days median2013: 77 days median2014: 104 days median2015: 54 days median2016: 168 days median
2007high 168 (2016) · low 54 (2015)2026

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

Recalls per year · MNI

1in 2018

2007: 262008: 82009: 32010: 12012: 12013: 42015: 12018: 1
2007high 26 (2007) · low 0 (2011)2026

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

Adverse event reports per year · MNI

80in 2025

2007: 832008: 1082009: 1382010: 1262011: 1462012: 2002013: 8242014: 3012015: 2602016: 1172017: 2472018: 1342019: 1882020: 1152021: 2702022: 2142023: 1222024: 1142025: 80
2007high 824 (2013) · low 80 (2025)2025

MAUDE reports naming product code MNI, 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
200720822683
200823648108
200918863138
201016741126
2011171110146
201219751200
201314774824
201461040301
201512541260
201671680117
20171—0247
20180—1134
20190—0188
20200—0115
20210—0270
20220—0214
20230—0122
20240—0114
20250—080
20260—0—

What is it indicated for?

When intended to promote fusion of the cervical spine and the thoracic spine, (C 1-T3), the NexLink Spinal 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 are also intended to provide stabilization to promote fusion following…

Read the full statement (107 words)

When intended to promote fusion of the cervical spine and the thoracic spine, (C 1-T3), the NexLink Spinal 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 are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C 1-T3). spine.

The use of multiaxial screws is limited to placement in T1 -T3 in treating thoracic conditions only. The multiaxial screws are not intended to be placed in the cervical spine.

Indications for use as stated in the FDA summary.

More from Spinal Concepts, Inc.

33 FDA decisions under this applicant name. See the company

  • K051000Fortitude Vue Vertebral Body Replacement DeviceSpinal Concepts, Inc. · 2005
  • K050706Harmony Port System, Model 1907 SeriesSpinal Concepts, Inc. · 20051 recall
  • K040096Spinal Concepts, Inc. Tandem Spinous Process Plate SystemSpinal Concepts, Inc. · 2004
  • K033663Spinal Concepts Inc. CodaSpinal Concepts, Inc. · 2004
  • K033517Spinal Concepts Inc. Cadence and TraxisSpinal Concepts, Inc. · 20041 recall

Recent decisions in MNI

The MNI category page

  • K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd. · 2017
  • K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd. · 2016
  • K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc. · 2016
  • K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A. · 2016
  • K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A. · 2016

https://510kreport.com/device/K031985 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031985: Spinal Concepts Inc. Nex-Link Spinal 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/K031985

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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