510(k) · Cleared
ClearedAtlas Spinal Cage, Models SC-150-007, 009, 011, 013, 015, 017.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Edge, LLC · MQP Spinal Vertebral Body Replacement Device
Cleared on Jun 8, 2006 as substantially equivalent to K990148 (Depuy Motech Acromed, 1999) and 1 other predicate after a 65-day review. Its family tree reaches back 5 generations to 2001. 1 later device descends from it.
- Decided
- Jun 8, 2006
- Review
- 65 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K003275 (2001). 7 ancestors in all, the oldest K841189 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK003275 Synthes Synmesh Spacer SystemSynthes (Usa) · 2001 · Recalled
- 4 generations backK020152 Synthes Vertebral Spacer TISynthes (Usa) · 2002
- 3 generations backK024364 Synthes Vertebral Spacer TI (Curved and Narrow)Synthes (Usa) · 2003
- 2 generations backK031302 Sustain SpacerGlobus Medical, Inc. · 2003
- 1 generation backK040284 Sustain Radiolucent SpacerGlobus Medical, Inc. · 2004
- This deviceK060916 Atlas Spinal Cage, Models SC-150-007, 009, 011, 013, 015, 017.Spinal Edge, LLC · 2006
- Descendant · cites it directly · 0 of its ownK092774 Atlas Intervertebral Body CageSpinal Edge, LLC · 2010
Most influential descendants
Showing 1 of 1 · See all- K092774Atlas Intervertebral Body CageSpinal Edge, LLC · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003275 | Synthes Synmesh Spacer System | Synthes (Usa) | 2001 | 14 |
| −4 | K020152 | Synthes Vertebral Spacer TI | Synthes (Usa) | 2002 | — |
| −3 | K024364 | Synthes Vertebral Spacer TI (Curved and Narrow) | Synthes (Usa) | 2003 | — |
| −2 | K031302 | Sustain Spacer | Globus Medical, Inc. | 2003 | — |
| −1 | K040284 | Sustain Radiolucent Spacer | Globus Medical, Inc. | 2004 | — |
| 0 (this device) | K060916 | Atlas Spinal Cage, Models SC-150-007, 009, 011, 013, 015, 017. | Spinal Edge, LLC | 2006 | — |
| +1 | K092774 | Atlas Intervertebral Body Cage | Spinal Edge, LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 |
|---|---|---|---|
| * | K990148 | Stackable Cage SystemSummary page 1…Name: Spinal Vertebral Body Replacement Device (21 CFR 888.3060), Class 11 3. Predicate Devices K990148 - Stackable Cage System - DePuy AcroMed, Inc. K040284 - Sustain Radiolucent Spacer - Globus Medical, Inc. 4.… | 1999 |
| * | K040284 | Sustain Radiolucent SpacerSummary page 1…(21 CFR 888.3060), Class 11 3. Predicate Devices K990148 - Stackable Cage System - DePuy AcroMed, Inc. K040284 - Sustain Radiolucent Spacer - Globus Medical, Inc. 4. Device Description The Spinal Edge ATLAS Spinal Cage… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092774 | Atlas Intervertebral Body Cage | 2010 | 0 |
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 5 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K092774 (Spinal Edge, LLC, 2010) has gone furthest, with 0 descendants of its own.
- 20 other devices also cite its predicate K990148.
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 Spinal Edge ATLAS Spinal Cage is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damage or unstable vertebral body due to tumor or trauma. The Spinal Edge ATLAS Spinal Cage is intended to be used with supplemental spinal fixation system 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…
Read the full statement (118 words)
The Spinal Edge ATLAS Spinal Cage is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damage or unstable vertebral body due to tumor or trauma. The Spinal Edge ATLAS Spinal Cage is intended to be used with supplemental spinal fixation system 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 of the spacer may if indicated be packed with bone grafting material. The Spinal Edge ATLAS Spinal Cage is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period of time.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060916 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060916: Atlas Spinal Cage, Models SC-150-007, 009, 011, 013, 015, 017..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060916
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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