510(k) · Cleared
ClearedAtlas Intervertebral Body Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Edge, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Feb 2, 2010 as substantially equivalent to K060916 (Spinal Edge, LLC, 2006) and 2 other predicates after a 146-day review. Its family tree reaches back 7 generations to 1984.
- Decided
- Feb 2, 2010
- Review
- 146 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K841189 (1984). 19 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 6 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 5 generations backK020887 Ebi Ais Spine SystemEbi, L.P. · 2002
- 4 generations backK040482 Ebi Esl Spine Spacer SystemEbi, L.P. · 2004
- 3 generations backK042268 Ebi Cas Spine Spacer SystemEbi, L.P. · 2004
- 2 generations backK052384 Lanx VBR SystemLanx, LLC · 2005
- 1 generation backK083815 Lanx Fusion SystemLanx, Inc. · 2009
- This deviceK092774 Atlas Intervertebral Body CageSpinal Edge, LLC · 2010
View 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 | K020887 | Ebi Ais Spine System | Ebi, L.P. | 2002 | — |
| −4 | K040482 | Ebi Esl Spine Spacer System | Ebi, L.P. | 2004 | — |
| −3 | K042268 | Ebi Cas Spine Spacer System | Ebi, L.P. | 2004 | — |
| −2 | K052384 | Lanx VBR System | Lanx, LLC | 2005 | — |
| −1 | K083815 | Lanx Fusion System | Lanx, Inc. | 2009 | — |
| 0 (this device) | K092774 | Atlas Intervertebral Body Cage | Spinal Edge, LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 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 MAX? 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K060916 | Atlas Spinal Cage, Models SC-150-007, 009, 011, 013, 015, 017.Summary page 1…and (21 CFR 888.3080), Class 1I Product Code MAX 3. Predicate Devices K060916 - Atlas Spinal Cage K083815 - Lanx Fusion System K990148 - Stackable Cage System 4. Device… | 2006 |
| * | K083815 | Lanx Fusion SystemSummary page 1…080), Class 1I Product Code MAX 3. Predicate Devices K060916 - Atlas Spinal Cage K083815 - Lanx Fusion System K990148 - Stackable Cage System 4. Device Description This submission is… | 2009 |
| * | K990148 | Stackable Cage SystemSummary page 1…MAX 3. Predicate Devices K060916 - Atlas Spinal Cage K083815 - Lanx Fusion System K990148 - Stackable Cage System 4. Device Description This submission is intended to seek clearance for a product… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 19 ancestors has a recall of any class.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
When used as vertebral body replacement, the ATLAS -Intervertebral Body Cage is indicated for use in the thoracolumbar spine (T I-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma. The ATLAS Intervertebral Body Cage is intended to be used. with supplemental fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e. posterior pedicle screw and rod systems, anterior plate systems, and…
Read the full statement (235 words)
When used as vertebral body replacement, the ATLAS -Intervertebral Body Cage is indicated for use in the thoracolumbar spine (T I-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma. The ATLAS Intervertebral Body Cage is intended to be used. with supplemental fixation systems that have been labeled 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) the interior spacer may be packed with bone graftingtmaterial. The ATLAS Intervertebral Body Cage has been designed to provide anterior column support even in the absence of fusion for a prolonged period of time.
When used as a lumbar intervertebral body fusion device the ATLAS Intervertebral Body Cage is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 to SI. DDD is defined and discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have six months of non-operative treatment. These DDD patients may have had previous non-fusion spinal surgery at the involved spinal level(s). The ATLAS Intervertebral Body Cage is implanted via an anterior or posterior approach and is combined with supplemental fixation.
For either intended use, the ATLAS Intervertebral Body Cage must be used with supplemental internal fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092774 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092774: Atlas Intervertebral Body Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092774
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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