510(k) · Cleared
ClearedAtlas Spine Pivoting System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atlas Spine, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Aug 10, 2010 as substantially equivalent to K080699 (Alphatec Spine, Inc., 2008) and 2 other predicates after a 147-day review. Its family tree reaches back 6 generations to 2001. 4 later devices descend from it.
- Decided
- Aug 10, 2010
- Review
- 147 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K010530 (2001). 14 ancestors in all, the oldest P950002 (1996). 4 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 5 generations backK062083 Synfix -LRSynthes Spine Co.Lp · 2007
- 4 generations backK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · Recalled
- 3 generations backK073470 Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008
- 2 generations backK083661 Avs TL Peek SpacersStryker Corp. · 2009
- 1 generation backK092017 Pivotec Lumbar Interbody Fusion Device (Lifd)Captiva Spine, Inc. · 2009
- This deviceK100743 Atlas Spine Pivoting SystemAtlas Spine, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK172419 Velofix™ TLIF CageU&I Corporation · 2017
- Descendant · 2 generations on · 1 of its ownK181829 Velofix TLIF CageU&I Corporation · 2018
- Descendant · cites it directly · 0 of its ownK243816 Testa TP Pivoting Spacer SystemSpine Wave, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK183243 Velofix TLIF CageU&I Corporation · 2019
Most influential descendants
Showing 4 of 4 · See all- K172419Velofix™ TLIF CageU&I Corporation · 2017 · cites it directly2descendants
- K181829Velofix TLIF CageU&I Corporation · 2018 · 2 generations on1descendant
- K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc. · 2025 · cites it directly0descendants
- K183243Velofix TLIF CageU&I Corporation · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −5 | K062083 | Synfix -LR | Synthes Spine Co.Lp | 2007 | — |
| −4 | K072253 | Synfix-LR Spacer | Synthes Spine Co.Lp | 2007 | 1 |
| −3 | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXX | Stryker Spine | 2008 | — |
| −2 | K083661 | Avs TL Peek Spacers | Stryker Corp. | 2009 | — |
| −1 | K092017 | Pivotec Lumbar Interbody Fusion Device (Lifd) | Captiva Spine, Inc. | 2009 | — |
| 0 (this device) | K100743 | Atlas Spine Pivoting System | Atlas Spine, Inc. | 2010 | — |
| +1 | K172419 | Velofix™ TLIF Cage | U&I Corporation | 2017 | — |
| +2 | K181829 | Velofix TLIF Cage | U&I Corporation | 2018 | — |
| +1 | K243816 | Testa TP Pivoting Spacer System | Spine Wave, Inc. | 2025 | — |
| +2 | K183243 | Velofix TLIF Cage | U&I Corporation | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 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 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 |
|---|---|---|---|
| * | K080699 | Novel Spinal Spacer SystemSummary page 1…ce [IBFD] Predicate Device: Novel® Spinal Spacer System Alphatec Spinal, Inc.~ K080699 Atlas Spine Spacer Atlas Spine, Inc.… | 2008 |
| * | K091406 | Atlas Spine Spacer | 2009 |
| * | K092017 | Pivotec Lumbar Interbody Fusion Device (Lifd)Summary page 1…6 Pivotec Lumbar Interbody Fusion Device Captiva Spine, Inc. K092017 Device Description: The Atlas Spine Pivoting System is an intervertebral body fusion device for use with autogenous bone graft… | 2009 |
What descends from it? (4)
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 9 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 5 of the 14 ancestors have a recall of any class.
- Of its descendants, K172419 (U&I Corporation, 2017) has gone furthest, with 2 descendants of its own.
- 10 other devices also cite its predicate K080699.
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?
The Atlas Spine Pivoting System is indicated for spinal 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 level(s). These patients should have had six months of non-operative treatment. The Atlas Spine Pivoting System is to be used with a supplemental fixation system and autogenous bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100743 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100743: Atlas Spine Pivoting System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100743
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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