510(k) Report

510(k) · Cleared

Cleared

Nexlink Oct System, Model 7000 Series

K090060510(k) TraditionalCleared Jun 2, 2009144-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

Abbott Spine, Inc. · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Jun 2, 2009 as substantially equivalent to K021009 (Spinal Concepts, Inc., 2002) after a 144-day review. Its family tree reaches back 2 generations to 2001. 8 later devices descend from it.

Decided
Jun 2, 2009
Review
144 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K011969 (2001). 8 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared2015: 2 descendants cleared2012: 1 descendant cleared2023: 1 descendant cleared2014: 1 descendant cleared2016: 1 descendant cleared2017: 1 descendant clearedK011969 · Synthes Cervifix System · Synthes (Usa) · 2001K021009 · Octafix Occipital Cervical Plating System · Spinal Concepts, Inc. · 2002200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant K021009 · Octafix Occipital Cervical Plating System · Spinal Concepts, Inc. · 2002K011969 · Synthes Cervifix System · Synthes (Usa) · 20010+5
  1. Root · 2 generations backK011969 Synthes Cervifix SystemSynthes (Usa) · 2001
  2. 1 generation backK021009 Octafix Occipital Cervical Plating SystemSpinal Concepts, Inc. · 2002
  3. This deviceK090060 Nexlink Oct System, Model 7000 SeriesAbbott Spine, Inc. · 2009
  4. Descendant · cites it directly · 4 of its ownK121877 Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System…Exactech, Inc. · 2013
  5. Descendant · 2 generations on · 3 of its ownK133374 Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I · 2014
  6. Descendant · 3 generations on · 2 of its ownK150254 Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2015 · Recalled
  7. Descendant · 4 generations on · 1 of its ownK161498 Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2016
  8. Descendant · cites it directly · 1 of its ownK113346 Neon SystemUlrich GmbH & Co. KG · 2012

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2012: 12013: 12014: 12015: 22016: 12017: 12023: 1
2012high 2 (2015) · low 0 (2018)2026

Most influential descendants

Showing 5 of 8 · See all
  • K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc. · 2013 · cites it directly4descendants
  • K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I · 2014 · 2 generations on3descendants
  • K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2015 · 3 generations on2descendants
  • K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2016 · 4 generations on1descendant
  • K113346Neon SystemUlrich GmbH & Co. KG · 2012 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K011969Synthes Cervifix SystemSynthes (Usa)2001—
−1K021009Octafix Occipital Cervical Plating SystemSpinal Concepts, Inc.2002—
0 (this device)K090060Nexlink Oct System, Model 7000 SeriesAbbott Spine, Inc.2009—
+1K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System…Exactech, Inc.2013—
+2K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I2014—
+3K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20153
+4K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2016—
+1K113346Neon SystemUlrich GmbH & Co. KG2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201310
201410
201520
201610
201710
202310
FIG. 1 — Lineage of K090060, 2001–2023Source: 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? (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
*K021009Octafix Occipital Cervical Plating System
Summary page 1
…EM CLASSIFICATION REFERENCE: 21 CFR § 888.3050 PREDICATE DEVICE: OctaFix® Occipital Cervical Fixation System, K021009, Abbott Spine, cleared 18 June 2002. DEVICE DESCRIPTION: NexLink OCT is the…
Spinal Concepts, Inc.2002—

Also cleared against K021009: 2 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134
K113346Neon SystemUlrich GmbH & Co. KG20121
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 8 years and passes through 3 companies; a new generation was cleared every 7.0 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K121877 (Exactech, Inc., 2013) has gone furthest, with 4 descendants of its own.
  • 2 other devices also cite its predicate K021009.

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. 2009, this device’s year, is highlighted.

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?

The Nex-Link OCT Occipital Cervical Plating System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for the following indications: degenerative disc disease (neck pain of discogenic origin with degeneration of the disk as confirmed by patient history and radiological studies), spondylolisthesis, spinal stenosis, fracture/dislocation, atlanto-axial fracture with…

Read the full statement (132 words)

The Nex-Link OCT Occipital Cervical Plating System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for the following indications: degenerative disc disease (neck pain of discogenic origin with degeneration of the disk as confirmed by patient history and radiological studies), spondylolisthesis, spinal stenosis, fracture/dislocation, atlanto-axial fracture with instability, occipito-cervical dislocation, revision of previous cervical spine fusion surgery and tumors.

The Cancellous and Cortical Bone Screws (3.5mm and 4mm diameters; 6mm-20mm threaded lengths) are used with the NexLink OCT Occipital Cervical Plating System to allow for occipital fixation and limited to occipital fixation only. The 4mm Cannulated Side Loading Closed Screws are limited to placement in the upper thoracic spine (T1-T3) for additional stabilization of the cervical spine for the indications specified above.

Indications for use as stated in the FDA summary.

Also cleared against K021009

2 other devices cite the same predicate.

  • K062505Nex-Link Spinal Fixation System Offset Connectors, 2121-XX SeriesAbbott Spine, Inc. · 2006
  • K052402Vertex Reconstruction SystemMedtronic Sofamor Danek · 2005

More from Abbott Spine, Inc.

13 FDA decisions under this applicant name. See the company

  • K082032Sequoia Spinal System (Model 3306), Speedlink Transverse Connector (Models 3308, 3309, 3310)Abbott Spine, Inc. · 20081 recall
  • K081622Universal Clamp Stainless Steel SystemAbbott Spine, Inc. · 2008
  • K073202Ardis SpacerAbbott Spine, Inc. · 20081 Class I recall
  • K072672Sequoia Spinal System, Model 3300 SeriesAbbott Spine, Inc. · 20072 recalls
  • K071174Pathfinder System Polyaxial Pedicle ScrewsAbbott Spine, Inc. · 20074 recalls

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/K090060 · printed Nov 4, 2026

Cite this page

510(k) Report. “K090060: Nexlink Oct System, Model 7000 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090060

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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