510(k) · Cleared
Recalled · Class II · 2013Atlas Spine Vertebral Body Replacement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atlas Spine, LLC · MQP Spinal Vertebral Body Replacement Device
Cleared on Feb 26, 2007 after a 126-day review. The FDA summary names no predicate by number. 7 later devices descend from it. It has been recalled once.
- Decided
- Feb 26, 2007
- Review
- 126 days
- Class
- Class II
- Product code
- MQP
- Recalls
- 1
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK063205 Atlas Spine Vertebral Body ReplacementAtlas Spine, LLC · 2007
- Descendant · cites it directly · 6 of its ownK091406 Atlas Spine SpacerAtlas Spine, LLC · 2009 · Recalled
- Descendant · 2 generations on · 4 of its ownK100743 Atlas Spine Pivoting SystemAtlas Spine, Inc. · 2010
- Descendant · 3 generations on · 2 of its ownK172419 Velofix™ TLIF CageU&I Corporation · 2017
- Descendant · 4 generations on · 1 of its ownK181829 Velofix TLIF CageU&I Corporation · 2018
- Descendant · 3 generations on · 0 of its ownK243816 Testa TP Pivoting Spacer SystemSpine Wave, Inc. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K091406Atlas Spine SpacerAtlas Spine, LLC · 2009 · cites it directly6descendants
- K100743Atlas Spine Pivoting SystemAtlas Spine, Inc. · 2010 · 2 generations on4descendants
- K172419Velofix™ TLIF CageU&I Corporation · 2017 · 3 generations on2descendants
- K181829Velofix TLIF CageU&I Corporation · 2018 · 4 generations on1descendant
- K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K063205 | Atlas Spine Vertebral Body Replacement | Atlas Spine, LLC | 2007 | — |
| +1 | K091406 | Atlas Spine Spacer | Atlas Spine, LLC | 2009 | 1 |
| +2 | K100743 | Atlas Spine Pivoting System | Atlas Spine, Inc. | 2010 | — |
| +3 | K172419 | Velofix™ TLIF Cage | U&I Corporation | 2017 | — |
| +4 | K181829 | Velofix TLIF Cage | U&I Corporation | 2018 | — |
| +3 | K243816 | Testa TP Pivoting Spacer System | Spine Wave, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2025 | 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 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?
The FDA summary names no predicate by number.
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091406 | Atlas Spine Spacer | 2009 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 26, 2013 | Class II | Z-1616-2016 | Device Design | The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K091406 (Atlas Spine, LLC, 2009) has gone furthest, with 6 descendants of its own.
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. 2007, this device’s year, is highlighted.
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 Atlas Spine Vertebral Body Replacement (VBR) is intended for use in the thoracolumbar spine (T1-L5) for partial or complete replacement (i.e., 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 Atlas Spine VBR is also indicated for treating fractures of the thoracic and…
Read the full statement (140 words)
The Atlas Spine Vertebral Body Replacement (VBR) is intended for use in the thoracolumbar spine (T1-L5) for partial or complete replacement (i.e., 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 Atlas Spine VBR is also indicated for treating fractures of the thoracic and lumbar spine.
The Atlas Spine VBR is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The interior of the Atlas Spine VBR can be packed with bone. The device must be used with supplemental internal fixation systems cleared for the conditions listed above (i.e., tumor or trauma of T1-L5).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063205 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063205: Atlas Spine Vertebral Body Replacement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063205
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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