510(k) Report

510(k) · Cleared

Cleared

Spinal Fixation System

K092536510(k) TraditionalCleared Oct 30, 200972-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

Lanx, Inc. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Oct 30, 2009 after a 72-day review. The FDA summary names its predicate without a number. 21 later devices descend from it.

Decided
Oct 30, 2009
Review
72 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
0

21 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2014: 3 descendants cleared2011: 1 descendant cleared2012: 4 descendants cleared2015: 4 descendants cleared2016: 3 descendants cleared2017: 2 descendants cleared2018: 1 descendant cleared2020: 1 descendant cleared2026: 2 descendants cleared20052010201520202025
  1. This deviceK092536 Spinal Fixation SystemLanx, Inc. · 2009
  2. Descendant · cites it directly · 18 of its ownK103237 Lanx Spinal SystemLanx, Inc. · 2011
  3. Descendant · 2 generations on · 17 of its ownK120399 Lanx Spinal Fixation SystemLanx, LLC · 2012
  4. Descendant · cites it directly · 8 of its ownK121940 Lanx Spinal Fixation SystemLanx, Inc. · 2012
  5. Descendant · 3 generations on · 7 of its ownK122145 Lanx Spinal Fixation SystemLanx, Inc. · 2012 · Recalled
  6. Descendant · 2 generations on · 6 of its ownK123093 Stabilink Mis Spinal Fixation SystemSouthern Spine, LLC · 2012

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2011: 12012: 42014: 32015: 42016: 32017: 22018: 12020: 12026: 2
2011high 4 (2012) · low 0 (2013)2026

Most influential descendants

Showing 5 of 21 · See all
  • K103237Lanx Spinal SystemLanx, Inc. · 2011 · cites it directly18descendants
  • K120399Lanx Spinal Fixation SystemLanx, LLC · 2012 · 2 generations on17descendants
  • K121940Lanx Spinal Fixation SystemLanx, Inc. · 2012 · cites it directly8descendants
  • K122145Lanx Spinal Fixation SystemLanx, Inc. · 2012 · 3 generations on7descendants
  • K123093Stabilink Mis Spinal Fixation SystemSouthern Spine, LLC · 2012 · 2 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K092536Spinal Fixation SystemLanx, Inc.2009—
+1K103237Lanx Spinal SystemLanx, Inc.2011—
+2K120399Lanx Spinal Fixation SystemLanx, LLC2012—
+1K121940Lanx Spinal Fixation SystemLanx, Inc.2012—
+3K122145Lanx Spinal Fixation SystemLanx, Inc.20121
+2K123093Stabilink Mis Spinal Fixation SystemSouthern Spine, LLC2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201240
201430
201540
201630
201720
201810
202010
202620
FIG. 1 — Lineage of K092536, 2009–2026Source: 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 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? (3)

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
*—Lanx Spinal Fixation System
Named without a submission number
—
*—Stryker Spine Xia 3 Spinal System
Named without a submission number
—
*—Expedium Spine System
Named without a submission number
—

What descends from it? (21)

See all 21

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

NumberDeviceApplicantDecidedDescendants
K103237Lanx Spinal SystemLanx, Inc.201118
K121940Lanx Spinal Fixation SystemLanx, Inc.20128
K141508Romeo 2 Pad Posterior Axial DeviceSpineart20141

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?

  • Of its descendants, K103237 (Lanx, Inc., 2011) has gone furthest, with 18 descendants of its own.

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 Lanx Spinal Fixation System (SFS) is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The System is intended for use with autograft or allograft. The Lanx Spinal Fixation System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization and stabilization of spinal segments in…

Read the full statement (128 words)

The Lanx Spinal Fixation System (SFS) is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The System is intended for use with autograft or allograft.

The Lanx Spinal Fixation System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Indications for use as stated in the FDA summary.

More from Lanx, Inc.

23 FDA decisions under this applicant name. See the company

  • K131547Lanx Fusion SystemLanx, Inc. · 20131 recall
  • K131156Lanx Spinal Fixation SystemLanx, Inc. · 2013
  • K123767Lanx Fusion System- SALanx, Inc. · 20134 recalls
  • K121316Lanx Spinal Fization SystemLanx, Inc. · 2012
  • K122145Lanx Spinal Fixation SystemLanx, Inc. · 20121 recall

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/K092536 · printed Nov 4, 2026

Cite this page

510(k) Report. “K092536: Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092536

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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