510(k) · Cleared
Recalled · Class II · 2009Atlas Spine Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atlas Spine, LLC · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Oct 19, 2007 as substantially equivalent to K010515 (Interpore Cross Intl., 2001) and 3 other predicates after a 51-day review. Its family tree reaches back 5 generations to 1995. 5 later devices descend from it. It has been recalled once.
- Decided
- Oct 19, 2007
- Review
- 51 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 5 generations to K950697 (1995). 23 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 4 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 3 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 2 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 1 generation backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
- This deviceK072426 Atlas Spine Pedicle Screw SystemAtlas Spine, LLC · 2007
- Descendant · cites it directly · 4 of its ownK110842 Atlas Spine Pedicle Screw SystemAtlas Spine, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK112759 Apclo Pedicle Screw SystemsAtlas Spine, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK251154 RIVA Posterior Fixation System; RIVA Posterior Fixation System…Ht Medical D.B.A. Xenix Medical · 2025
- Descendant · 3 generations on · 0 of its ownK262193 RIVA® Posterior Fixation System with NanoACTIV Surface Technology…Xenix Medical · 2026
- Descendant · 2 generations on · 0 of its ownK111634 Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc. · 2012
Most influential descendants
Showing 5 of 5 · See all- K110842Atlas Spine Pedicle Screw SystemAtlas Spine, Inc. · 2011 · cites it directly4descendants
- K112759Apclo Pedicle Screw SystemsAtlas Spine, Inc. · 2011 · cites it directly2descendants
- K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical · 2025 · 2 generations on1descendant
- K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical · 2026 · 3 generations on0descendants
- K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc. · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −4 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −3 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −2 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −1 | K060979 | Xia Titanium and 4.5 Spinal Systems | Stryker Spine | 2006 | — |
| 0 (this device) | K072426 | Atlas Spine Pedicle Screw System | Atlas Spine, LLC | 2007 | — |
| +1 | K110842 | Atlas Spine Pedicle Screw System | Atlas Spine, Inc. | 2011 | — |
| +1 | K112759 | Apclo Pedicle Screw Systems | Atlas Spine, Inc. | 2011 | — |
| +2 | K251154 | RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation… | Ht Medical D.B.A. Xenix Medical | 2025 | — |
| +3 | K262193 | RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA®… | Xenix Medical | 2026 | — |
| +2 | K111634 | Xenon (TM) Pedicle Screw System | Alphatec Spine, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 NKB? 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 NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K010515 | Modification to Synergy Spinal SystemSummary page 1…redicate Devices: SynergyTM Spinal System Interpore Cross International K010515 Moss Miami Spinal System DePuy AcroMed, Inc.… | 2001 |
| * | K010742 | Moss Miami 5.5MM Titanium Pin NutSummary page 1…010515 Moss Miami Spinal System DePuy AcroMed, Inc. K010742 XIA® Spine System Stryker Spine… | 2001 |
| * | K984251 | Xia Spine SystemSummary page 1…K010742 XIA® Spine System Stryker Spine K984251, K060979 Intended Use: The Atlas Spine Pedicle Screw System is intended for noncervical pedicle fixation for the following ind… | 1999 |
| * | K060979 | Xia Titanium and 4.5 Spinal SystemsSummary page 1…K010742 XIA® Spine System Stryker Spine K984251, K060979 Intended Use: The Atlas Spine Pedicle Screw System is intended for noncervical pedicle fixation for the following indications:… | 2006 |
What descends from it? (5)
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 |
|---|---|---|---|---|
| Jun 4, 2009 | Class II | Z-2274-2012 | Component design/selection | Atlas Spine, Inc. recalled their Apelo Modular Screwdriver, a component of the Apelo Pedicle Screw System Instrumentation, because of complaints received about the tip breaking. If the tip is fractured inside of the modular screw, the tip… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 5 months on median.
- 2 of the 23 ancestors have a recall of any class.
- Of its descendants, K110842 (Atlas Spine, Inc., 2011) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K010515.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The Atlas Spine Pedicle Screw System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072426 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072426: Atlas Spine Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072426
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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