510(k) · Cleared
Recalled · Class II · 2013Atlas Spine Spacer
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 Sep 4, 2009 as substantially equivalent to K063205 (Atlas Spine, LLC, 2007) and 1 other predicate after a 115-day review. Its family tree reaches back 1 generation to 2007. 6 later devices descend from it. It has been recalled once.
- Decided
- Sep 4, 2009
- Review
- 115 days
- Class
- Class II
- Product code
- MQP
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K063205 (2007). 2 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK063205 Atlas Spine Vertebral Body ReplacementAtlas Spine, LLC · 2007 · Recalled
- This deviceK091406 Atlas Spine SpacerAtlas Spine, LLC · 2009
- Descendant · cites it directly · 4 of its ownK100743 Atlas Spine Pivoting SystemAtlas Spine, Inc. · 2010
- Descendant · 2 generations on · 2 of its ownK172419 Velofix™ TLIF CageU&I Corporation · 2017
- Descendant · 3 generations on · 1 of its ownK181829 Velofix TLIF CageU&I Corporation · 2018
- Descendant · 2 generations on · 0 of its ownK243816 Testa TP Pivoting Spacer SystemSpine Wave, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK183243 Velofix TLIF CageU&I Corporation · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K100743Atlas Spine Pivoting SystemAtlas Spine, Inc. · 2010 · cites it directly4descendants
- K172419Velofix™ TLIF CageU&I Corporation · 2017 · 2 generations on2descendants
- K181829Velofix TLIF CageU&I Corporation · 2018 · 3 generations on1descendant
- K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc. · 2025 · 2 generations on0descendants
- K183243Velofix TLIF CageU&I Corporation · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K063205 | Atlas Spine Vertebral Body Replacement | Atlas Spine, LLC | 2007 | 1 |
| 0 (this device) | K091406 | Atlas Spine Spacer | Atlas Spine, LLC | 2009 | — |
| +1 | K100743 | Atlas Spine Pivoting System | Atlas Spine, Inc. | 2010 | — |
| +2 | K172419 | Velofix™ TLIF Cage | U&I Corporation | 2017 | — |
| +3 | K181829 | Velofix TLIF Cage | U&I Corporation | 2018 | — |
| +2 | K243816 | Testa TP Pivoting Spacer System | Spine Wave, Inc. | 2025 | — |
| +3 | K183243 | Velofix TLIF Cage | U&I Corporation | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K063205 | Atlas Spine Vertebral Body ReplacementSummary page 1…BR] Predicate Devices: Atlas Spine Vertebral Body Replacement Atlas Spine, Inc. K063205 SeaSpine Spacer System SeaSpine, Inc.… | 2007 |
| * | K082310 | Hollywood, Pacifica, Redondo, VenturaSummary page 1…K063205 SeaSpine Spacer System SeaSpine, Inc. K082310 Intended Use: Intervertebral Body Fusion Device: The Atlas Spine Spacer is indicated for intervertebral body fusion procedures… | 2008 |
What descends from it? (6)
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)
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?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K100743 (Atlas Spine, Inc., 2010) has gone furthest, with 4 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. 2009, 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?
Intervertebral Body Fusion Device: The Atlas Spine Spacer is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels(s).…
Read the full statement (256 words)
Intervertebral Body Fusion Device: The Atlas Spine Spacer is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels(s). This device is to be used with autogenous bone graft. The Atlas Spine Spacer is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Vertebral Body Replacement: When used as a vertebral body replacement, the Atlas Spine Spacer 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 Spacer is also indicated for treating fractures of the thoracic and lumbar spine.
The Atlas Spine Spacer 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 Spacer can be packed with autograft and/or allograft. 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/K091406 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091406: Atlas Spine Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091406
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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