510(k) · Cleared
ClearedLanx VBR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lanx, LLC · MQP Spinal Vertebral Body Replacement Device
Cleared on Oct 7, 2005 as substantially equivalent to K003709 (United States Surgical, A Division of Tyco Healthc, 2001) and 3 other predicates after a 38-day review. Its family tree reaches back 5 generations to 1984. 455 later devices descend from it.
- Decided
- Oct 7, 2005
- Review
- 38 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K841189 (1984). 12 ancestors in all. 455 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 4 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 3 generations backK020887 Ebi Ais Spine SystemEbi, L.P. · 2002
- 2 generations backK040482 Ebi Esl Spine Spacer SystemEbi, L.P. · 2004
- 1 generation backK042268 Ebi Cas Spine Spacer SystemEbi, L.P. · 2004
- This deviceK052384 Lanx VBR SystemLanx, LLC · 2005
- Descendant · cites it directly · 451 of its ownK083815 Lanx Fusion SystemLanx, Inc. · 2009
- Descendant · 2 generations on · 328 of its ownK102738 Lanx Fusion SystemLanx, LLC · 2011 · Recalled
- Descendant · 3 generations on · 324 of its ownK123767 Lanx Fusion System- SALanx, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 269 of its ownK131122 S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC · 2013
- Descendant · 3 generations on · 265 of its ownK140106 S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc. · 2014
Showing 5 of 455 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 455 · See all- K083815Lanx Fusion SystemLanx, Inc. · 2009 · cites it directly451descendants
- K102738Lanx Fusion SystemLanx, LLC · 2011 · 2 generations on328descendants
- K123767Lanx Fusion System- SALanx, Inc. · 2013 · 3 generations on324descendants
- K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC · 2013 · 2 generations on269descendants
- K140106S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc. · 2014 · 3 generations on265descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −4 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −3 | K020887 | Ebi Ais Spine System | Ebi, L.P. | 2002 | — |
| −2 | K040482 | Ebi Esl Spine Spacer System | Ebi, L.P. | 2004 | — |
| −1 | K042268 | Ebi Cas Spine Spacer System | Ebi, L.P. | 2004 | — |
| 0 (this device) | K052384 | Lanx VBR System | Lanx, LLC | 2005 | — |
| +1 | K083815 | Lanx Fusion System | Lanx, Inc. | 2009 | — |
| +2 | K102738 | Lanx Fusion System | Lanx, LLC | 2011 | 1 |
| +3 | K123767 | Lanx Fusion System- SA | Lanx, Inc. | 2013 | 4 |
| +2 | K131122 | S128 Anterior Lumbar Interbody Fusion (Alif) System | Renovis Surgical Technologies, LLC | 2013 | — |
| +3 | K140106 | S128 Anterior Lumbar Interbody Fusion (Alif) System | Renovis Surgical Technologies, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 6 | 0 |
| 2014 | 9 | 0 |
| 2015 | 6 | 0 |
| 2016 | 6 | 0 |
| 2017 | 13 | 0 |
| 2018 | 28 | 0 |
| 2019 | 19 | 0 |
| 2020 | 34 | 0 |
| 2021 | 35 | 0 |
| 2022 | 51 | 0 |
| 2023 | 63 | 0 |
| 2024 | 66 | 0 |
| 2025 | 57 | 0 |
| 2026 | 54 | 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 MQP? 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 MQP device
- #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K003709 | Surgical Dynamics Mesh Cage SystemSummary page 1…MQP 4. Equivalent Predicate Device: Lanx LLCbelieves that the L.an-x VBR is substantially equivalent to the followings I. K003709, Mesh Cage, Surgical Dynamics 2. KOO 1340, Stackable Cage, DePuy 3. K040928, PEEK Cage, Interpore/Cross… | 2001 |
| * | K001340 | Stackable Cage SystemSummary page 3…icate Device: Lanxv LLCbelieves that the Lain VBR is substantially equivalent to the following: 1, K003709, Mesh Cage, Surgical Dynamics 2. K001340, Stackable Cage, DePuy 3. K040928, PEEK Cage, Interpore/Cross 4. K042268, EBI CAS Spine Spacer System, EBI. L… | 2000 |
| * | K040928 | Expandable Peek VBR ImplantSummary page 1…L.an-x VBR is substantially equivalent to the followings I. K003709, Mesh Cage, Surgical Dynamics 2. KOO 1340, Stackable Cage, DePuy 3. K040928, PEEK Cage, Interpore/Cross 4. K042268, EBI CAS Spine Spacer System, EBI. LP. Equivalence can be seen in th… | 2004 |
| * | K042268 | Ebi Cas Spine Spacer SystemSummary page 1…lowings I. K003709, Mesh Cage, Surgical Dynamics 2. KOO 1340, Stackable Cage, DePuy 3. K040928, PEEK Cage, Interpore/Cross 4. K042268, EBI CAS Spine Spacer System, EBI. LP. Equivalence can be seen in the design, material composition, surgical technique… | 2004 |
What descends from it? (455)
See all 4553 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 21 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K083815 (Lanx, Inc., 2009) has gone furthest, with 451 descendants of its own.
- 13 other devices also cite its predicate K003709.
How does its category compare?
All MQP devicesMQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQP
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQP
187in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQP
168in 2025
MAUDE reports naming product code MQP, 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 | 30 | 107 | 2 | 61 |
| 2008 | 17 | 47 | 0 | 76 |
| 2009 | 11 | 115 | 14 | 111 |
| 2010 | 6 | 174 | 2 | 166 |
| 2011 | 8 | 237 | 1 | 121 |
| 2012 | 7 | 82 | 2 | 141 |
| 2013 | 3 | 90 | 0 | 207 |
| 2014 | 5 | 125 | 0 | 216 |
| 2015 | 8 | 126 | 0 | 258 |
| 2016 | 0 | — | 0 | 129 |
| 2017 | 9 | 97 | 0 | 141 |
| 2018 | 6 | 152 | 0 | 130 |
| 2019 | 8 | 93 | 0 | 117 |
| 2020 | 3 | 103 | 15 | 157 |
| 2021 | 0 | — | 0 | 208 |
| 2022 | 1 | — | 1 | 137 |
| 2023 | 1 | — | 0 | 71 |
| 2024 | 4 | 187 | 0 | 98 |
| 2025 | 0 | — | 0 | 168 |
| 2026 | 3 | 102 | 0 | — |
What is it indicated for?
The Lanx VBR System is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for usc as a vertebral body replacement in the thoracolumbar spine (from TI to L5) The Lanx VBR System may also be used in the thoracolumbar spine (i.e., Ti- L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in…
Read the full statement (157 words)
The Lanx VBR System is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for usc as a vertebral body replacement in the thoracolumbar spine (from TI to L5) The Lanx VBR System may also be used in the thoracolumbar spine (i.e., Ti- L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body, The Lanx VBR System is also indicated for treating fractures of the thoracic and lumbar spine. The Lanx VBR System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. For either indication the system must be used with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052384 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052384: Lanx VBR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052384
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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