510(k) · Cleared
ClearedLanx Spinal 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 Mar 25, 2011 as substantially equivalent to K043484 (Lanx, LLC, 2005) and 6 other predicates after a 143-day review. Its family tree reaches back 3 generations to 2004. 18 later devices descend from it.
- Decided
- Mar 25, 2011
- Review
- 143 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 3 generations to K033826 (2004). 10 ancestors in all, the oldest K032037 (2003). 18 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK033826 Orthopedic Alliance Spine SystemOrthopedic Alliance, LLC · 2004 · Recalled
- 2 generations backK043484 Lanx Spinal Fixation SystemLanx, LLC · 2005
- 1 generation backK071633 Lanx Deformity SystemLanx, LLC · 2007
- This deviceK103237 Lanx Spinal SystemLanx, Inc. · 2011
- Descendant · cites it directly · 17 of its ownK120399 Lanx Spinal Fixation SystemLanx, LLC · 2012
- Descendant · cites it directly · 8 of its ownK121940 Lanx Spinal Fixation SystemLanx, Inc. · 2012
- Descendant · 2 generations on · 7 of its ownK122145 Lanx Spinal Fixation SystemLanx, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 6 of its ownK123093 Stabilink Mis Spinal Fixation SystemSouthern Spine, LLC · 2012
- Descendant · 3 generations on · 5 of its ownK133363 Interbridge Interspinous Posterior Fixation SystemLdr Spine USA, Inc. · 2014
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K120399Lanx Spinal Fixation SystemLanx, LLC · 2012 · cites it directly17descendants
- K121940Lanx Spinal Fixation SystemLanx, Inc. · 2012 · cites it directly8descendants
- K122145Lanx Spinal Fixation SystemLanx, Inc. · 2012 · 2 generations on7descendants
- K123093Stabilink Mis Spinal Fixation SystemSouthern Spine, LLC · 2012 · 2 generations on6descendants
- K133363Interbridge Interspinous Posterior Fixation SystemLdr Spine USA, Inc. · 2014 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K033826 | Orthopedic Alliance Spine System | Orthopedic Alliance, LLC | 2004 | 1 |
| −2 | K043484 | Lanx Spinal Fixation System | Lanx, LLC | 2005 | — |
| −1 | K071633 | Lanx Deformity System | Lanx, LLC | 2007 | — |
| 0 (this device) | K103237 | Lanx Spinal System | Lanx, Inc. | 2011 | — |
| +1 | K120399 | Lanx Spinal Fixation System | Lanx, LLC | 2012 | — |
| +1 | K121940 | Lanx Spinal Fixation System | Lanx, Inc. | 2012 | — |
| +2 | K122145 | Lanx Spinal Fixation System | Lanx, Inc. | 2012 | 1 |
| +2 | K123093 | Stabilink Mis Spinal Fixation System | Southern Spine, LLC | 2012 | — |
| +3 | K133363 | Interbridge Interspinous Posterior Fixation System | Ldr Spine USA, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 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? (8)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K043484 | Lanx Spinal Fixation SystemSummary page 1…hosis (KWP), 21 CFR 888.3050 Device Class: Class II and Class Ill Predicate Device Information Lanx Spinal Fixation System K043484, K071633, K071877, K083581, K0905252, K092536, K093285, K100935 Intended Use / Indications for Use T… | 2005 |
| * | K071633 | Lanx Deformity SystemSummary page 1…P), 21 CFR 888.3050 Device Class: Class II and Class Ill Predicate Device Information Lanx Spinal Fixation System K043484, K071633, K071877, K083581, K0905252, K092536, K093285, K100935 Intended Use / Indications for Use The Lanx S… | 2007 |
| * | K071877 | Lanx Spinal Fixation SystemSummary page 1…21 CFR 888.3050 Device Class: Class II and Class Ill Predicate Device Information Lanx Spinal Fixation System K043484, K071633, K071877, K083581, K0905252, K092536, K093285, K100935 Intended Use / Indications for Use The Lanx Spinal Fix… | 2007 |
| * | K083581 | Lanx Spinal Fixation SystemSummary page 1…21 CFR 888.3050 Device Class: Class II and Class Ill Predicate Device Information Lanx Spinal Fixation System K043484, K071633, K071877, K083581, K0905252, K092536, K093285, K100935 Intended Use / Indications for Use The Lanx Spinal Fixation Sys… | 2009 |
| Kept off the family tree | K090525 | FDA’s K090525 is Loi System Our reading of the summary gave K090525, FDA’s number for Loi System (Palomar Medical Products, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Lanx Spinal Fixation System”. Kept off the family tree. Summary page 1…21 CFR 888.3050 Device Class: Class II and Class Ill Predicate Device Information Lanx Spinal Fixation System K043484, K071633, K071877, K083581, K0905252, K092536, K093285, K100935 Intended Use / Indications for Use The Lanx Spinal Fixation System (SFS)… | 2009 |
| * | K092536 | Spinal Fixation SystemSummary page 1…CFR 888.3050 Device Class: Class II and Class Ill Predicate Device Information Lanx Spinal Fixation System K043484, K071633, K071877, K083581, K0905252, K092536, K093285, K100935 Intended Use / Indications for Use The Lanx Spinal Fixation System (SFS) is intend… | 2009 |
| * | K093285 | Modification to Lanx Spinal Fixation SystemSummary page 1…Class II and Class Ill Predicate Device Information Lanx Spinal Fixation System K043484, K071633, K071877, K083581, K0905252, K092536, K093285, K100935 Intended Use / Indications for Use The Lanx Spinal Fixation System (SFS) is intended to be used to help provide immobil… | 2009 |
| * | K100935 | Lanx Spinal Fixation SystemSummary page 1…ss II and Class Ill Predicate Device Information Lanx Spinal Fixation System K043484, K071633, K071877, K083581, K0905252, K092536, K093285, K100935 Intended Use / Indications for Use The Lanx Spinal Fixation System (SFS) is intended to be used to help provide immobilization a… | 2010 |
What descends from it? (18)
See all 182 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)
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 7 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K120399 (Lanx, LLC, 2012) has gone furthest, with 17 descendants of its own.
- 5 other devices also cite its predicate K043484.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 allograft. The Lanx Spinal Fixation System is intended for posterior, non-cervical (TI-52/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization and stabilization of spinal segments in…
Read the full statement (221 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 (TI-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 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 (TI-SI). 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 Spinous Process Fusion Plate is intended for use with bone graft material, not intended for standalone use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103237 · printed Nov 3, 2026
Cite this page
510(k) Report. “K103237: Lanx Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K103237
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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