510(k) · Cleared
ClearedLanx Facet Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lanx, Inc. · MRW System, Facet Screw Spinal Device
Cleared on Aug 16, 2010 as substantially equivalent to K020411 (Nuvasive, Inc., 2002) and 1 other predicate after a 94-day review. Its family tree reaches back 1 generation to 2002. 2 later devices descend from it.
- Decided
- Aug 16, 2010
- Review
- 94 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K020411 (2002). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK020411 Nuvasive Triad Facet Screw SystemNuvasive, Inc. · 2002
- This deviceK101364 Lanx Facet Screw SystemLanx, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK202309 Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty…Zimmer Biomet Spine, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK113011 Spartan S3 Facet SystemAmendia, Inc. · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K020411 | Nuvasive Triad Facet Screw System | Nuvasive, Inc. | 2002 | — |
| 0 (this device) | K101364 | Lanx Facet Screw System | Lanx, Inc. | 2010 | — |
| +1 | K202309 | Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation… | Zimmer Biomet Spine, Inc. | 2020 | — |
| +1 | K113011 | Spartan S3 Facet System | Amendia, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2020 | 1 | 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 MRW? 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 MRW device
- #1 K230840 PMT Facet Fixation System, Lumbar (PMT FFS-LX)score 26.0 · 6 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K020411 | Nuvasive Triad Facet Screw SystemSummary page 1…me of Device Lanx Facet Screw System Common or Usual Name Facet Screw System Classification Unclassified, Product Code - MRW Predicate Device NuVasive Facet Screw (K02041 1, K01 323) Globus Corridor Fixation System (K083442) Intended Use I Indications for Use The Lanx Facet Screw System is intended… | 2002 |
| Kept off the family tree | K010323 | NuVasive Facet Screw Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K083442 | Corridor Fixation SystemSummary page 1…al Name Facet Screw System Classification Unclassified, Product Code - MRW Predicate Device NuVasive Facet Screw (K02041 1, K01 323) Globus Corridor Fixation System (K083442) Intended Use I Indications for Use The Lanx Facet Screw System is intended to stabilize the spine as an aid to fusion through… | 2009 |
What descends from it? (2)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All MRW devicesMRW System, Facet Screw Spinal Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MRW
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MRW
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MRW
3in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRW
3in 2025
MAUDE reports naming product code MRW, 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 | 0 | — | 0 | 1 |
| 2008 | 3 | 88 | 0 | 0 |
| 2009 | 6 | 89 | 0 | 2 |
| 2010 | 6 | 108 | 0 | 7 |
| 2011 | 3 | 122 | 3 | 62 |
| 2012 | 4 | 119 | 0 | 6 |
| 2013 | 7 | 110 | 0 | 4 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 2 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 2 | — | 0 | 4 |
| 2019 | 3 | 90 | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 3 | 252 | 0 | 0 |
| 2023 | 3 | 190 | 0 | 1 |
| 2024 | 7 | 50 | 0 | 2 |
| 2025 | 7 | 97 | 0 | 3 |
| 2026 | 5 | 169 | 0 | — |
What is it indicated for?
The Lanx Facet Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1 for 3.5mm and 4.0mmn screws .and from LI to SI for 4.5mm screws. For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the…
Read the full statement (180 words)
The Lanx Facet Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1 for 3.5mm and 4.0mmn screws .and from LI to SI for 4.5mm screws. For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle. The Lanx Facet Screw System is indicated for treatment of any or all of the following:
* pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity;
* spondylolisthesis;
* spondylolysis;
* degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies;
* degeneration of the facets with instability and;
* trauma including spinal fractures and/or dislocations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101364 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101364: Lanx Facet Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101364
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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