510(k) · Cleared
Recalled · Class II · 2012Lanx Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lanx, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Aug 17, 2012 as substantially equivalent to K120399 (Lanx, LLC, 2012) and 2 other predicates after a 29-day review. Its family tree reaches back 8 generations to 1995. 7 later devices descend from it. It has been recalled once.
- Decided
- Aug 17, 2012
- Review
- 29 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 8 generations to K950697 (1995). 70 ancestors in all, the oldest K933881 (1994). 7 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 7 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 6 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 5 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 4 generations backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
- 3 generations backK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008
- 2 generations backK090230 Expedium Spine SystemDepuy Spine, Inc. · 2009
- 1 generation backK120099 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
- This deviceK122145 Lanx Spinal Fixation SystemLanx, Inc. · 2012
- Descendant · cites it directly · 4 of its ownK171838 TiLock2 Spinal SystemGenesys Spine · 2017
- Descendant · 2 generations on · 2 of its ownK201427 Trivergent Spinal Fixation SystemBenvenue Medical, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK253169 Duet™ Spinal Fixation SystemBox Spine, LLC · 2026
- Descendant · cites it directly · 1 of its ownK152132 X-spine Pedicle Screw SystemX-Spine Systems, Inc. · 2015 · Recalled
- Descendant · 4 generations on · 0 of its ownK262712 Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K171838TiLock2 Spinal SystemGenesys Spine · 2017 · cites it directly4descendants
- K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc. · 2020 · 2 generations on2descendants
- K253169Duet™ Spinal Fixation SystemBox Spine, LLC · 2026 · 3 generations on1descendant
- K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc. · 2015 · cites it directly1descendant
- K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −7 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −6 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −5 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −4 | K060979 | Xia Titanium and 4.5 Spinal Systems | Stryker Spine | 2006 | — |
| −3 | K082942 | Modfication to: Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −2 | K090230 | Expedium Spine System | Depuy Spine, Inc. | 2009 | — |
| −1 | K120099 | Range Spinal System (Mesa and Denali) | K2m, Inc. | 2012 | — |
| 0 (this device) | K122145 | Lanx Spinal Fixation System | Lanx, Inc. | 2012 | — |
| +1 | K171838 | TiLock2 Spinal System | Genesys Spine | 2017 | — |
| +2 | K201427 | Trivergent Spinal Fixation System | Benvenue Medical, Inc. | 2020 | — |
| +3 | K253169 | Duet™ Spinal Fixation System | Box Spine, LLC | 2026 | — |
| +1 | K152132 | X-spine Pedicle Screw System | X-Spine Systems, Inc. | 2015 | 1 |
| +4 | K262712 | Duet™ Spinal Fixation System | Duet Spine Holdings, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 7 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 6 | 0 |
| 2004 | 7 | 0 |
| 2005 | 8 | 0 |
| 2006 | 4 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2026 | 2 | 0 |
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 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K120399 | Lanx Spinal Fixation SystemSummary page 1…21 CFR §888.3070, §888.3050 Device Class: Class 11 and Class Ill Predicate Device Information Lanx Spinal Fixation System (K 120399) GS Medical AnyPlus Spinal Fixation System (K091717) K2M Range Spinal System (K 120099) Device Description The Lanx Spinal Fix… | 2012 |
| * | K091717 | Any Plus Spinal Fixation SystemSummary page 1…050 Device Class: Class 11 and Class Ill Predicate Device Information Lanx Spinal Fixation System (K 120399) GS Medical AnyPlus Spinal Fixation System (K091717) K2M Range Spinal System (K 120099) Device Description The Lanx Spinal Fixation System consists of various screws, hooks, rods… | 2010 |
| * | K120099 | Range Spinal System (Mesa and Denali)Summary page 1…Class 11 and Class Ill Predicate Device Information Lanx Spinal Fixation System (K 120399) GS Medical AnyPlus Spinal Fixation System (K091717) K2M Range Spinal System (K 120099) Device Description The Lanx Spinal Fixation System consists of various screws, hooks, rods, plates, connectors, etc. that are… | 2012 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 30, 2012 | Class II | Z-1146-2015 | Process control | Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 5 months on median.
- 7 of the 70 ancestors have a recall of any class.
- Of its descendants, K171838 (Genesys Spine, 2017) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K120399.
How does its category compare?
All NKB devicesNKB 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
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
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 allogiift. 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 allogiift.
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.
https://510kreport.com/device/K122145 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122145: 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/K122145
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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