510(k) Report

510(k) · Cleared

Cleared

Stabilink Mis Spinal Fixation System

K123093510(k) TraditionalCleared Dec 20, 201279-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

Southern Spine, LLC · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Dec 20, 2012 as substantially equivalent to K071877 (Lanx, LLC, 2007) and 6 other predicates after a 79-day review. Its family tree reaches back 6 generations to 2004. 6 later devices descend from it.

Decided
Dec 20, 2012
Review
79 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
7

Its longest line of descent runs back 6 generations to K033826 (2004). 15 ancestors in all, the oldest K032037 (2003). 6 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor2010: 1 other ancestor2009: 4 other ancestors2007: 1 other ancestor2003: 1 other ancestor2005: 1 other ancestor2014: 2 descendants cleared2015: 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 · 2012K121940 · Lanx Spinal Fixation System · Lanx, Inc. · 2012200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 3 other ancestors 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant K121940 · Lanx Spinal Fixation System · Lanx, Inc. · 2012K120399 · 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 · 6 generations backK033826 Orthopedic Alliance Spine SystemOrthopedic Alliance, LLC · 2004 · Recalled
  2. 5 generations backK043484 Lanx Spinal Fixation SystemLanx, LLC · 2005
  3. 4 generations backK071633 Lanx Deformity SystemLanx, LLC · 2007
  4. 3 generations backK103237 Lanx Spinal SystemLanx, Inc. · 2011
  5. 2 generations backK120399 Lanx Spinal Fixation SystemLanx, LLC · 2012
  6. 1 generation backK121940 Lanx Spinal Fixation SystemLanx, Inc. · 2012
  7. This deviceK123093 Stabilink Mis Spinal Fixation SystemSouthern Spine, LLC · 2012
  8. Descendant · cites it directly · 5 of its ownK133363 Interbridge Interspinous Posterior Fixation SystemLdr Spine USA, Inc. · 2014
  9. Descendant · cites it directly · 3 of its ownK142378 Interspinous Plate SystemPrecision Spine, Inc. · 2014
  10. Descendant · 2 generations on · 2 of its ownK151863 Precision Spine Interspinous Plate SystemPrecision Spine, Inc. · 2015
  11. Descendant · 3 generations on · 0 of its ownK160465 Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc. · 2016
  12. Descendant · 2 generations on · 0 of its ownK160568 Precision Spine Interspinous Plate SystemPrecision Spine, Inc. · 2016

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2014: 22015: 22016: 2
2014high 2 (2014) · low 0 (2017)2026

Most influential descendants

Showing 5 of 6 · See all
  • K133363Interbridge Interspinous Posterior Fixation SystemLdr Spine USA, Inc. · 2014 · cites it directly5descendants
  • K142378Interspinous Plate SystemPrecision Spine, Inc. · 2014 · cites it directly3descendants
  • K151863Precision Spine Interspinous Plate SystemPrecision Spine, Inc. · 2015 · 2 generations on2descendants
  • K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc. · 2016 · 3 generations on0descendants
  • K160568Precision Spine Interspinous Plate SystemPrecision Spine, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K033826Orthopedic Alliance Spine SystemOrthopedic Alliance, LLC20041
−5K043484Lanx Spinal Fixation SystemLanx, LLC2005—
−4K071633Lanx Deformity SystemLanx, LLC2007—
−3K103237Lanx Spinal SystemLanx, Inc.2011—
−2K120399Lanx Spinal Fixation SystemLanx, LLC2012—
−1K121940Lanx Spinal Fixation SystemLanx, Inc.2012—
0 (this device)K123093Stabilink Mis Spinal Fixation SystemSouthern Spine, LLC2012—
+1K133363Interbridge Interspinous Posterior Fixation SystemLdr Spine USA, Inc.2014—
+1K142378Interspinous Plate SystemPrecision Spine, Inc.2014—
+2K151863Precision Spine Interspinous Plate SystemPrecision Spine, Inc.2015—
+3K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.2016—
+2K160568Precision Spine Interspinous Plate SystemPrecision Spine, 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
201420
201520
201620
FIG. 1 — Lineage of K123093, 2004–2016Source: 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
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What was it cleared against? (7)

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
*K071877Lanx Spinal Fixation System
Summary page 1
…KWP Leaiallv Marketed Predicate Device: Lanx, Inc. - Lanx Spinal Fixation System (Includes Lanx Aspen and L-Plate Systems) - 510(k) # K(071877 (initial Aspen); K(083581; K090252; K(100935 (initial L-Plate); 1(103091; K121940 Medtronic Sofamor Danek, Inc. -…
Lanx, LLC2007—
*K083581Lanx Spinal Fixation System
Summary page 1
…allv Marketed Predicate Device: Lanx, Inc. - Lanx Spinal Fixation System (Includes Lanx Aspen and L-Plate Systems) - 510(k) # K(071877 (initial Aspen); K(083581; K090252; K(100935 (initial L-Plate); 1(103091; K121940 Medtronic Sofamor Danek, Inc. - CO HORIZON® Spinous Proce…
Lanx, Inc.2009—
*K090252Modification to: Lanx Spinal Fixation System
Summary page 1
…keted Predicate Device: Lanx, Inc. - Lanx Spinal Fixation System (Includes Lanx Aspen and L-Plate Systems) - 510(k) # K(071877 (initial Aspen); K(083581; K090252; K(100935 (initial L-Plate); 1(103091; K121940 Medtronic Sofamor Danek, Inc. - CO HORIZON® Spinous Process Plate…
Lanx, Inc.2009—
*K100935Lanx Spinal Fixation System
Summary page 1
…cate Device: Lanx, Inc. - Lanx Spinal Fixation System (Includes Lanx Aspen and L-Plate Systems) - 510(k) # K(071877 (initial Aspen); K(083581; K090252; K(100935 (initial L-Plate); 1(103091; K121940 Medtronic Sofamor Danek, Inc. - CO HORIZON® Spinous Process Plate (Also call…
Lanx, Inc.2010—
*K103091Lanx Spinal Fixation System
Summary page 1
…pinal Fixation System (Includes Lanx Aspen and L-Plate Systems) - 510(k) # K(071877 (initial Aspen); K(083581; K090252; K(100935 (initial L-Plate); 1(103091; K121940 Medtronic Sofamor Danek, Inc. - CO HORIZON® Spinous Process Plate (Also called Spire ) - 510(k) # K03203…
Lanx, Inc.2011—
*K121940Lanx Spinal Fixation System
Summary page 1
…xation System (Includes Lanx Aspen and L-Plate Systems) - 510(k) # K(071877 (initial Aspen); K(083581; K090252; K(100935 (initial L-Plate); 1(103091; K121940 Medtronic Sofamor Danek, Inc. - CO HORIZON® Spinous Process Plate (Also called Spire ) - 510(k) # K032037 Device…
Lanx, Inc.2012—
*K032037CD Horizon (Addition of Spinous Process Plate)
Summary page 1
…K(100935 (initial L-Plate); 1(103091; K121940 Medtronic Sofamor Danek, Inc. - CO HORIZON® Spinous Process Plate (Also called Spire ) - 510(k) # K032037 Device Description: The StabiLinktm MIS Spinal Fixation System is a posterior, non-pedicle supplemental fixation dev…
Medtronic Sofamor Danek2003—

Also cleared against K071877: 17 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K133363Interbridge Interspinous Posterior Fixation SystemLdr Spine USA, Inc.20145
K142378Interspinous Plate SystemPrecision Spine, Inc.20143
K142217Reliance Interspinous Plate SystemReliance Medical Systems, LLC20150

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 4 companies; a new generation was cleared every 11 months on median.
  • 1 of the 15 ancestors has a recall of any class.
  • Of its descendants, K133363 (Ldr Spine USA, Inc., 2014) has gone furthest, with 5 descendants of its own.
  • 17 other devices also cite its predicate K071877.

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. 2012, 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 StabiLinkTM MIS Spinal Fixation System 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 (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); tumor. It is not intended for stand-alone use.

Indications for use as stated in the FDA summary.

Also cleared against K071877

17 other devices cite the same predicate.

  • K173334SeaSpine Spinous Process SystemSeaSpine Orthopedics Corporation · 2018
  • K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC · 2017
  • K153302coflex-IFParadigm Spine, LLC · 2016
  • K140046Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC · 2015
  • K141508Romeo 2 Pad Posterior Axial DeviceSpineart · 2014
  • K133091Zip Mis Interspinous Fusion SystemAurora Spine · 2013

More from Southern Spine, LLC

4 FDA decisions under this applicant name. See the company

  • K211845Deploy Expandable Interbody SystemSouthern Spine, LLC · 2021
  • K130948C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC · 2013
  • K063764Southern Spine Anterior Cervical Stabilization System, Kwik- Fix Cervical System, and Kwik-Fix / TS Cervical…Southern Spine, LLC · 2007

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/K123093 · printed Nov 5, 2026

Cite this page

510(k) Report. “K123093: Stabilink Mis Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123093

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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