510(k) · Cleared
ClearedAtlas Spine Vertebral Body Replacement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atlas Spine, Inc. · MQP Spinal Vertebral Body Replacement Device
Cleared on Mar 9, 2007 as substantially equivalent to K050553 (Alphatec/Nexmed, 2005) and 6 other predicates after a 113-day review. Its family tree reaches back 7 generations to 1984. 2 later devices descend from it.
- Decided
- Mar 9, 2007
- Review
- 113 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 7 generations to K841189 (1984). 28 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 6 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 5 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 4 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 3 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 2 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 1 generation backK050449 Quantum Vertebral Body ReplacementQuantum Orthopedics, Inc. · 2005
- This deviceK063464 Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK081880 Atlas Spine SpacerAtlas Spine, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK071497 Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc. · 2007
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 |
|---|---|---|---|---|---|
| −7 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −6 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −5 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −4 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −3 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −2 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −1 | K050449 | Quantum Vertebral Body Replacement | Quantum Orthopedics, Inc. | 2005 | — |
| 0 (this device) | K063464 | Atlas Spine Vertebral Body Replacement | Atlas Spine, Inc. | 2007 | — |
| +1 | K081880 | Atlas Spine Spacer | Atlas Spine, Inc. | 2008 | — |
| +1 | K071497 | Atlas Spine Vertebral Body Replacement | Atlas Spine, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 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? (7)
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 |
|---|---|---|---|
| * | K050553 | Novel VBR Spinal SystemSummary page 1…Class II per 21 CFR §888.3060 Product Code: MQP Predicate Devices: NovelTM VBR Spinal System K050553 Pioneer Vertebral Body Replacement Device K043206, K06115… | 2005 |
| * | K043206 | Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer)Summary page 1…inal System K050553 Pioneer Vertebral Body Replacement Device K043206, K061151 Quantum Vertebral Body Replacement K050449, K052… | 2005 |
| * | K061151 | Pioneer Vertebral Spacer (Vertebral Spacer)Summary page 1…em K050553 Pioneer Vertebral Body Replacement Device K043206, K061151 Quantum Vertebral Body Replacement K050449, K052641, K061… | 2006 |
| * | K050449 | Quantum Vertebral Body ReplacementSummary page 1…nt Device K043206, K061151 Quantum Vertebral Body Replacement K050449, K052641, K061576, K062004 Intended Use: The Atlas Spine Vertebral Body Replacement (VBR) is intended for use in the thoracolum… | 2005 |
| * | K052641 | Modification to: Quantum Vertebral Body ReplacementSummary page 1…K043206, K061151 Quantum Vertebral Body Replacement K050449, K052641, K061576, K062004 Intended Use: The Atlas Spine Vertebral Body Replacement (VBR) is intended for use in the thoracolumbar spine… | 2006 |
| * | K061576 | Modification to Quantum Vertebral Body Replacement SystemSummary page 1…K043206, K061151 Quantum Vertebral Body Replacement K050449, K052641, K061576, K062004 Intended Use: The Atlas Spine Vertebral Body Replacement (VBR) is intended for use in the thoracolumbar spine (T1-L5)… | 2006 |
| * | K062004 | Modification to Quantum Vertebral Body ReplacementSummary page 1…K043206, K061151 Quantum Vertebral Body Replacement K050449, K052641, K061576, K062004 Intended Use: The Atlas Spine Vertebral Body Replacement (VBR) is intended for use in the thoracolumbar spine (T1-L5) for parti… | 2006 |
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?
- The line of descent spans 23 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 28 ancestors have a recall of any class.
- Of its descendants, K081880 (Atlas Spine, Inc., 2008) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K050553.
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 (158 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. This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063464 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063464: Atlas Spine Vertebral Body Replacement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063464
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