510(k) Report

510(k) · Cleared

Cleared

Lanx Spinal Fization System

K121316510(k) TraditionalCleared Sep 10, 2012131-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 Sep 10, 2012 as substantially equivalent to K103091 (Lanx, Inc., 2011) and 5 other predicates after a 131-day review. Its family tree reaches back 4 generations to 2003. 3 later devices descend from it.

Decided
Sep 10, 2012
Review
131 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
6

Its longest line of descent runs back 4 generations to K032037 (2003). 13 ancestors in all. 3 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 3 other ancestors2010: 1 other ancestor2008: 1 other ancestor2005: 2 other ancestors2004: 2 other ancestors2013: 1 descendant cleared2018: 1 descendant cleared2020: 1 descendant clearedK032037 · CD Horizon (Addition of Spinous Process Plate) · Medtronic Sofamor Danek · 2003K043053 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K071877 · Lanx Spinal Fixation System · Lanx, LLC · 2007K100354 · Primal OK Interspinous Fusion System · Osteomed LP · 2010200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 1 other ancestor3 generations back: 2 other ancestors4 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 1 descendant K100354 · Primal OK Interspinous Fusion System · Osteomed LP · 2010K071877 · Lanx Spinal Fixation System · Lanx, LLC · 2007K043053 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K032037 · CD Horizon (Addition of Spinous Process Plate) · Medtronic Sofamor Danek · 20030
  1. Root · 4 generations backK032037 CD Horizon (Addition of Spinous Process Plate)Medtronic Sofamor Danek · 2003
  2. 3 generations backK043053 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  3. 2 generations backK071877 Lanx Spinal Fixation SystemLanx, LLC · 2007
  4. 1 generation backK100354 Primal OK Interspinous Fusion SystemOsteomed LP · 2010
  5. This deviceK121316 Lanx Spinal Fization SystemLanx, Inc. · 2012
  6. Descendant · cites it directly · 1 of its ownK131156 Lanx Spinal Fixation SystemLanx, Inc. · 2013
  7. Descendant · 2 generations on · 0 of its ownK202309 Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty…Zimmer Biomet Spine, Inc. · 2020
  8. Descendant · cites it directly · 0 of its ownK173334 SeaSpine Spinous Process SystemSeaSpine Orthopedics Corporation · 2018

Most influential descendants

Showing 3 of 3 · See all
  • K131156Lanx Spinal Fixation SystemLanx, Inc. · 2013 · cites it directly1descendant
  • K202309Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero…Zimmer Biomet Spine, Inc. · 2020 · 2 generations on0descendants
  • K173334SeaSpine Spinous Process SystemSeaSpine Orthopedics Corporation · 2018 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K032037CD Horizon (Addition of Spinous Process Plate)Medtronic Sofamor Danek2003—
−3K043053Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−2K071877Lanx Spinal Fixation SystemLanx, LLC2007—
−1K100354Primal OK Interspinous Fusion SystemOsteomed LP2010—
0 (this device)K121316Lanx Spinal Fization SystemLanx, Inc.2012—
+1K131156Lanx Spinal Fixation SystemLanx, Inc.2013—
+2K202309Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation…Zimmer Biomet Spine, Inc.2020—
+1K173334SeaSpine Spinous Process SystemSeaSpine Orthopedics Corporation2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200420
200520
200810
201010
201130

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201810
202010
FIG. 1 — Lineage of K121316, 2003–2020Source: 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? (6)

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
*K103091Lanx Spinal Fixation System
Summary page 1
…le Screw Spinal System and/or Spinal Interlaminal Fixation Orthosis (per 21 CFR 888.3050 and/or 888.3070). Predicate Device Information K103091 Lanx Spinous Process Plate K073278 Nuvasive Affix Spinous Process Plating System K103205 Alphatec S…
Lanx, Inc.2011—
*K073278Spinous Process Plate System
Summary page 1
…inal Fixation Orthosis (per 21 CFR 888.3050 and/or 888.3070). Predicate Device Information K103091 Lanx Spinous Process Plate K073278 Nuvasive Affix Spinous Process Plating System K103205 Alphatec Spine BridgePoint Spinous Process Fixation Sys…
Nuvasive, Inc.2008—
*K103205Bridgepoint Spinous Process Camp- Posterior Fixation System
Summary page 1
…FR 888.3050 and/or 888.3070). Predicate Device Information K103091 Lanx Spinous Process Plate K073278 Nuvasive Affix Spinous Process Plating System K103205 Alphatec Spine BridgePoint Spinous Process Fixation System K100354 OsteoMed PrimaLOK Interspinous Fusion Syst…
Alphatec Spine, Inc.2011—
*K100354Primal OK Interspinous Fusion System
Summary page 1
…Lanx Spinous Process Plate K073278 Nuvasive Affix Spinous Process Plating System K103205 Alphatec Spine BridgePoint Spinous Process Fixation System K100354 OsteoMed PrimaLOK Interspinous Fusion System K102 195 Globus SP-Fix Spinous Process Fixation Plate K102020…
Osteomed LP2010—
*K102195SP-Fix Spinous Process Fixation Plate
Summary page 1
…pinous Process Plating System K103205 Alphatec Spine BridgePoint Spinous Process Fixation System K100354 OsteoMed PrimaLOK Interspinous Fusion System K102 195 Globus SP-Fix Spinous Process Fixation Plate K102020 SpineFrontier InSpan Interspinous Fixation System Inten…
Globus Medical, Inc.2011—
*K102020Vega Span Spinous Process Plate System
Summary page 1
…BridgePoint Spinous Process Fixation System K100354 OsteoMed PrimaLOK Interspinous Fusion System K102 195 Globus SP-Fix Spinous Process Fixation Plate K102020 SpineFrontier InSpan Interspinous Fixation System Intended Use / Indications for Use The Lanx Spinal Fixation System…
Spinefrontier, Inc.2010—

Also cleared against K103091: 3 other devices →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K131156Lanx Spinal Fixation SystemLanx, Inc.20131
K173334SeaSpine Spinous Process SystemSeaSpine Orthopedics Corporation20180

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 9 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
  • 1 of the 13 ancestors has a recall of any class.
  • Of its descendants, K131156 (Lanx, Inc., 2013) has gone furthest, with 1 descendant of its own.
  • 3 other devices also cite its predicate K103091.

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 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 (219 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.

The Lanx 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 (T1-S1). 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 with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The Lanx 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 K103091

3 other devices cite the same predicate.

  • K123232Spineology Spinous Process PlateSpineology, Inc. · 2013
  • K123093Stabilink Mis Spinal Fixation SystemSouthern Spine, LLC · 2012
  • K121940Lanx Spinal Fixation SystemLanx, Inc. · 2012

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
  • K122145Lanx Spinal Fixation SystemLanx, Inc. · 20121 recall
  • K121940Lanx Spinal Fixation SystemLanx, Inc. · 2012

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/K121316 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121316: Lanx Spinal Fization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121316

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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