510(k) Report

510(k) · Cleared

Cleared

Lanx Spinal Fixation System

K121940510(k) SpecialCleared Aug 2, 201231-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 Aug 2, 2012 as substantially equivalent to K043484 (Lanx, LLC, 2005) and 10 other predicates after a 31-day review. Its family tree reaches back 5 generations to 2004. 8 later devices descend from it.

Decided
Aug 2, 2012
Review
31 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
12

Its longest line of descent runs back 5 generations to K033826 (2004). 14 ancestors in all, the oldest K032037 (2003). 8 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor2010: 1 other ancestor2009: 4 other ancestors2007: 1 other ancestor2005: 1 other ancestor2003: 1 other ancestor2012: 1 descendant cleared2015: 3 descendants cleared2014: 2 descendants cleared2016: 2 descendants clearedK033826 · Orthopedic Alliance Spine System · Orthopedic Alliance, LLC · 2004 · recalledK043484 · Lanx Spinal Fixation System · Lanx, LLC · 2005K071633 · Lanx Deformity System · Lanx, LLC · 2007K103237 · Lanx Spinal System · Lanx, Inc. · 2011K120399 · Lanx Spinal Fixation System · Lanx, LLC · 2012200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant K120399 · Lanx Spinal Fixation System · Lanx, LLC · 2012K103237 · Lanx Spinal System · Lanx, Inc. · 2011K071633 · Lanx Deformity System · Lanx, LLC · 2007K043484 · Lanx Spinal Fixation System · Lanx, LLC · 2005K033826 · Orthopedic Alliance Spine System · Orthopedic Alliance, LLC · 2004 · recalled−50
  1. Root · 5 generations backK033826 Orthopedic Alliance Spine SystemOrthopedic Alliance, LLC · 2004 · Recalled
  2. 4 generations backK043484 Lanx Spinal Fixation SystemLanx, LLC · 2005
  3. 3 generations backK071633 Lanx Deformity SystemLanx, LLC · 2007
  4. 2 generations backK103237 Lanx Spinal SystemLanx, Inc. · 2011
  5. 1 generation backK120399 Lanx Spinal Fixation SystemLanx, LLC · 2012
  6. This deviceK121940 Lanx Spinal Fixation SystemLanx, Inc. · 2012
  7. Descendant · cites it directly · 6 of its ownK123093 Stabilink Mis Spinal Fixation SystemSouthern Spine, LLC · 2012
  8. Descendant · 2 generations on · 5 of its ownK133363 Interbridge Interspinous Posterior Fixation SystemLdr Spine USA, Inc. · 2014
  9. Descendant · 2 generations on · 3 of its ownK142378 Interspinous Plate SystemPrecision Spine, Inc. · 2014
  10. Descendant · 3 generations on · 2 of its ownK151863 Precision Spine Interspinous Plate SystemPrecision Spine, Inc. · 2015
  11. Descendant · 4 generations on · 0 of its ownK160465 Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc. · 2016

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2012: 12014: 22015: 32016: 2
2012high 3 (2015) · low 0 (2013)2026

Most influential descendants

Showing 5 of 8 · See all
  • K123093Stabilink Mis Spinal Fixation SystemSouthern Spine, LLC · 2012 · cites it directly6descendants
  • K133363Interbridge Interspinous Posterior Fixation SystemLdr Spine USA, Inc. · 2014 · 2 generations on5descendants
  • K142378Interspinous Plate SystemPrecision Spine, Inc. · 2014 · 2 generations on3descendants
  • K151863Precision Spine Interspinous Plate SystemPrecision Spine, Inc. · 2015 · 3 generations on2descendants
  • K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc. · 2016 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K033826Orthopedic Alliance Spine SystemOrthopedic Alliance, LLC20041
−4K043484Lanx Spinal Fixation SystemLanx, LLC2005—
−3K071633Lanx Deformity SystemLanx, LLC2007—
−2K103237Lanx Spinal SystemLanx, Inc.2011—
−1K120399Lanx Spinal Fixation SystemLanx, LLC2012—
0 (this device)K121940Lanx Spinal Fixation SystemLanx, Inc.2012—
+1K123093Stabilink Mis Spinal Fixation SystemSouthern Spine, LLC2012—
+2K133363Interbridge Interspinous Posterior Fixation SystemLdr Spine USA, Inc.2014—
+2K142378Interspinous Plate SystemPrecision Spine, Inc.2014—
+3K151863Precision Spine Interspinous Plate SystemPrecision Spine, Inc.2015—
+4K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
200710
200940
201010
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201420
201530
201620
FIG. 1 — Lineage of K121940, 2004–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (12)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K043484Lanx Spinal Fixation System
Summary page 1
…r Spinal Interlamninal Fixation Orthosis (per 21 CER 888.3050 and/or 888.3070) Predicate Device Information Lanx Spinal Fixation System (K043484, K071633, K071877, K090252, K083581, K092536, K093285, K1 00935, K103091, K103237,.K120399, K120682) Intended Use / Indications…
Lanx, LLC2005—
*K071633Lanx Deformity System
Summary page 1
…Interlamninal Fixation Orthosis (per 21 CER 888.3050 and/or 888.3070) Predicate Device Information Lanx Spinal Fixation System (K043484, K071633, K071877, K090252, K083581, K092536, K093285, K1 00935, K103091, K103237,.K120399, K120682) Intended Use / Indications for Use…
Lanx, LLC2007—
*K071877Lanx Spinal Fixation System
Summary page 1
…inal Fixation Orthosis (per 21 CER 888.3050 and/or 888.3070) Predicate Device Information Lanx Spinal Fixation System (K043484, K071633, K071877, K090252, K083581, K092536, K093285, K1 00935, K103091, K103237,.K120399, K120682) Intended Use / Indications for Use The Lanx…
Lanx, LLC2007—
*K090252Modification to: Lanx Spinal Fixation System
Summary page 1
…tion Orthosis (per 21 CER 888.3050 and/or 888.3070) Predicate Device Information Lanx Spinal Fixation System (K043484, K071633, K071877, K090252, K083581, K092536, K093285, K1 00935, K103091, K103237,.K120399, K120682) Intended Use / Indications for Use The Lanx Spinal Fi…
Lanx, Inc.2009—
*K083581Lanx Spinal Fixation System
Summary page 1
…Orthosis (per 21 CER 888.3050 and/or 888.3070) Predicate Device Information Lanx Spinal Fixation System (K043484, K071633, K071877, K090252, K083581, K092536, K093285, K1 00935, K103091, K103237,.K120399, K120682) Intended Use / Indications for Use The Lanx Spinal Fixation Sy…
Lanx, Inc.2009—
*K092536Spinal Fixation System
Summary page 1
…Orthosis (per 21 CER 888.3050 and/or 888.3070) Predicate Device Information Lanx Spinal Fixation System (K043484, K071633, K071877, K090252, K083581, K092536, K093285, K1 00935, K103091, K103237,.K120399, K120682) Intended Use / Indications for Use The Lanx Spinal Fixation System (SF5…
Lanx, Inc.2009—
*K093285Modification to Lanx Spinal Fixation System
Summary page 1
…Orthosis (per 21 CER 888.3050 and/or 888.3070) Predicate Device Information Lanx Spinal Fixation System (K043484, K071633, K071877, K090252, K083581, K092536, K093285, K1 00935, K103091, K103237,.K120399, K120682) Intended Use / Indications for Use The Lanx Spinal Fixation System (SF5) is inte…
Lanx, LLC2009—
*K100935Lanx Spinal Fixation System
Summary page 1
…Orthosis (per 21 CER 888.3050 and/or 888.3070) Predicate Device Information Lanx Spinal Fixation System (K043484, K071633, K071877, K090252, K083581, K092536, K093285, K1 00935, K103091, K103237,.K120399, K120682) Intended Use / Indications for Use The Lanx Spinal Fixation System (SF5) is intended to be…
Lanx, Inc.2010—
*K103091Lanx Spinal Fixation System
Summary page 1
…per 21 CER 888.3050 and/or 888.3070) Predicate Device Information Lanx Spinal Fixation System (K043484, K071633, K071877, K090252, K083581, K092536, K093285, K1 00935, K103091, K103237,.K120399, K120682) Intended Use / Indications for Use The Lanx Spinal Fixation System (SF5) is intended to be used to…
Lanx, Inc.2011—
*K103237Lanx Spinal System
Summary page 1
…R 888.3050 and/or 888.3070) Predicate Device Information Lanx Spinal Fixation System (K043484, K071633, K071877, K090252, K083581, K092536, K093285, K1 00935, K103091, K103237,.K120399, K120682) Intended Use / Indications for Use The Lanx Spinal Fixation System (SF5) is intended to be used to help prov…
Lanx, Inc.2011—
*K120399Lanx Spinal Fixation System
Summary page 1
…0 and/or 888.3070) Predicate Device Information Lanx Spinal Fixation System (K043484, K071633, K071877, K090252, K083581, K092536, K093285, K1 00935, K103091, K103237,.K120399, K120682) Intended Use / Indications for Use The Lanx Spinal Fixation System (SF5) is intended to be used to help provide immob…
Lanx, LLC2012—
Kept off the family treeK120682Lanx Spinal Fixation System
Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
Summary page 1
…888.3070) Predicate Device Information Lanx Spinal Fixation System (K043484, K071633, K071877, K090252, K083581, K092536, K093285, K1 00935, K103091, K103237,.K120399, K120682) Intended Use / Indications for Use The Lanx Spinal Fixation System (SF5) is intended to be used to help provide immobilization…

Also cleared against K043484: 5 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K123093Stabilink Mis Spinal Fixation SystemSouthern Spine, LLC20126
K143388Affix IIS Spinous Process Plate SystemNu Vasive, Incorporated20150

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 11 months on median.
  • 1 of the 14 ancestors has a recall of any class.
  • Of its descendants, K123093 (Southern Spine, LLC, 2012) has gone furthest, with 6 descendants of its own.
  • 5 other devices also cite its predicate K043484.

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. 2012, 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 Lain Spinal Fixation System (SFS) is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fulsion of the thoracic, lumbar and/or sacral spine. The system is intended for use with autograt or allograft. The Lain Spinal Fixation System is intended for posterior, non-cervical (TlI-52/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization and stabilization of spinal segments in…

Read the full statement (219 words)

The Lain Spinal Fixation System (SFS) is intended to be used to help provide

immobilization and stabilization of spinal segments as an adjunct to fulsion of the thoracic,

lumbar and/or sacral spine. The system is intended for use with autograt or allograft.

The Lain Spinal Fixation System is intended for posterior, non-cervical (TlI-52/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 fuision.

The Lain Spinous Process Fusion Plate (SPFP) is a posterior, non-pedicle supplemental

fixation device, intended for use at a single level in the non-cervical spine (Tl-S 1). It is

intended for plate fixation/attachment to spinous processes for the purpose of achieving

supplemental fusion in the following conditions: degenerative disc disease (defined as back

pain of discogenic origin wit degenerationof the disc confirmed by history and radiographic

studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The Lain

SPFP is intended for use with bone graft material, not intended for stand-alone use.

Indications for use as stated in the FDA summary.

Also cleared against K043484

5 other devices cite the same predicate.

  • K121924Integra Interspinous Process SystemSeaspine, Inc. · 2013
  • K103237Lanx Spinal SystemLanx, Inc. · 2011
  • K090252Modification to: Lanx Spinal Fixation SystemLanx, Inc. · 2009
  • K071877Lanx Spinal Fixation SystemLanx, LLC · 2007
  • K071633Lanx Deformity SystemLanx, LLC · 2007

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/K121940 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121940: Lanx 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/K121940

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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