510(k) · Cleared
ClearedLanx Anterior Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lanx, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Apr 7, 2010 as substantially equivalent to K922543 (Sofamor Danek Mfg., Inc., 1993) and 4 other predicates after a 210-day review. Its family tree reaches back 4 generations to 1993. 1 later device descends from it.
- Decided
- Apr 7, 2010
- Review
- 210 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K922543 (1993). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK922543 Z-Plate Anterior Fixation SystemSofamor Danek Mfg., Inc. · 1993
- 3 generations backK013665 Pyramid Anterior Plate Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
- 2 generations backK043548 Blackstone Unity Anterior Lumbar Plate Fixation SystemBlackstone Medical, Inc. · 2005
- 1 generation backK061229 Unity LX Anterolateral Lumbar Plate Fixation SystemBlackstone Medical, Inc. · 2006
- This deviceK092765 Lanx Anterior Plating SystemLanx, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK202309 Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty…Zimmer Biomet Spine, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K202309Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero…Zimmer Biomet Spine, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922543 | Z-Plate Anterior Fixation System | Sofamor Danek Mfg., Inc. | 1993 | — |
| −3 | K013665 | Pyramid Anterior Plate Fixation System | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −2 | K043548 | Blackstone Unity Anterior Lumbar Plate Fixation System | Blackstone Medical, Inc. | 2005 | — |
| −1 | K061229 | Unity LX Anterolateral Lumbar Plate Fixation System | Blackstone Medical, Inc. | 2006 | — |
| 0 (this device) | K092765 | Lanx Anterior Plating System | Lanx, Inc. | 2010 | — |
| +1 | K202309 | Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation… | Zimmer Biomet Spine, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 KWQ? 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 KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K922543 | Z-Plate Anterior Fixation SystemSummary page 1…sual Name Spinal Fixation System Classification KWQ- 21 CFR 888.3060, Spinal Intervertebral Body Fixation Orthosis Predicate Device Medtronic Sofamor Danek Z-Plate (K922543, K982875) Blackstone Medical Unity (K(043548, 1(061229) Synthes ATB (K022791) Intended Use / Indications for Use The Lanx Ant… | 1993 |
| * | K982875 | Modification to Zplate-Atl Anterior Fixation SystemSummary page 1…Spinal Fixation System Classification KWQ- 21 CFR 888.3060, Spinal Intervertebral Body Fixation Orthosis Predicate Device Medtronic Sofamor Danek Z-Plate (K922543, K982875) Blackstone Medical Unity (K(043548, 1(061229) Synthes ATB (K022791) Intended Use / Indications for Use The Lanx Anterior Pla… | 1999 |
| * | K043548 | Blackstone Unity Anterior Lumbar Plate Fixation SystemSummary page 1…ion KWQ- 21 CFR 888.3060, Spinal Intervertebral Body Fixation Orthosis Predicate Device Medtronic Sofamor Danek Z-Plate (K922543, K982875) Blackstone Medical Unity (K(043548, 1(061229) Synthes ATB (K022791) Intended Use / Indications for Use The Lanx Anterior Plating System is intended to provide f… | 2005 |
| * | K061229 | Unity LX Anterolateral Lumbar Plate Fixation SystemSummary page 1…21 CFR 888.3060, Spinal Intervertebral Body Fixation Orthosis Predicate Device Medtronic Sofamor Danek Z-Plate (K922543, K982875) Blackstone Medical Unity (K(043548, 1(061229) Synthes ATB (K022791) Intended Use / Indications for Use The Lanx Anterior Plating System is intended to provide fixation of… | 2006 |
| * | K022791 | Synthes Anterior Tension Band (Atb) SystemSummary page 1…l Intervertebral Body Fixation Orthosis Predicate Device Medtronic Sofamor Danek Z-Plate (K922543, K982875) Blackstone Medical Unity (K(043548, 1(061229) Synthes ATB (K022791) Intended Use / Indications for Use The Lanx Anterior Plating System is intended to provide fixation of the thoracic, lumbar a… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202309 | Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero… | 2020 | 0 |
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 17 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K202309 (Zimmer Biomet Spine, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 10 other devices also cite its predicate K922543.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, 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 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
The Lanx Anterior Plating System is intended to provide fixation of the thoracic, lumbar and/or sacral spine (T1-S1) as an adjunct to fusion using autograft or allograft in skeletally mature patients 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), * Spinal stenosis (indicated for L1-S1…
Read the full statement (142 words)
The Lanx Anterior Plating System is intended to provide fixation of the thoracic, lumbar and/or sacral spine (T1-S1) as an adjunct to fusion using autograft or allograft in skeletally mature patients 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),
* Spinal stenosis (indicated for L1-S1 only);
* Spondylolisthesis;
* Deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis);
* Trauma (i.e., fracture, dislocation, or subluxation);
* Spondylolysis;
* Tumor;
* Pseudoarthrosis; and/or
* Failed previous fusion.
The Lanx Anterior Plating System is indicated for use via the lateral or anterolateral surgical approach for fixation of the thoracic and thoracolumbar spine, or via the anterior surgical approach for fixation of the lumbosacral spine below the bifurcation of the great vessels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092765 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092765: Lanx Anterior Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092765
Report an extraction error
Are you the manufacturer?
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