510(k) Report

510(k) · Cleared

Cleared

X-spine Cortical Bone Screw System

K180153510(k) TraditionalCleared Mar 15, 201855-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

X-Spine Systems, Inc. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Mar 15, 2018 as substantially equivalent to K152132 (X-Spine Systems, Inc., 2015) and 2 other predicates after a 55-day review. Its family tree reaches back 16 generations to 2004.

Decided
Mar 15, 2018
Review
55 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
3

Its longest line of descent runs back 16 generations to K040583 (2004). 213 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2015: 2 other ancestors2005: 20 other ancestors2014: 2 other ancestors2012: 4 other ancestors2010: 7 other ancestors2009: 10 other ancestors2002: 10 other ancestors2001: 17 other ancestors2000: 15 other ancestors1997: 3 other ancestors1995: 3 other ancestors2013: 1 other ancestor2007: 12 other ancestors2004: 22 other ancestors2003: 14 other ancestors1998: 9 other ancestors2011: 7 other ancestors2008: 14 other ancestors2006: 13 other ancestors1999: 3 other ancestors1996: 6 other ancestors1994: 1 other ancestor1984: 1 other ancestor1978: 1 other ancestor×7: 7 generations cleared close together, K040583 (2004), K041118 (2004), K042025 (2004), K043151 (2005), K050809 (2005), K052187 (2005), K053101 (2006) ×2: 2 generations cleared close together, K091442 (2009), K091974 (2009) K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010×2: 2 generations cleared close together, K112473 (2011), K113174 (2011) K130646 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2013K133221 · Arsenal Spinal Fixation System · Alphatec Spine, Inc. · 2014 · recalledK143149 · Arsenal Spinal Fixation System · Alphatec Spine, Inc. · 2015K152968 · Arsenal Spinal Fixation System · Alphatec Spine, Inc. · 201519801990200020102020
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 11 other ancestors3 generations back: 15 other ancestors4 generations back: 24 other ancestors5 generations back: 58 other ancestors6 generations back: 38 other ancestors7 generations back: 22 other ancestors8 generations back: 18 other ancestors9 generations back: 8 other ancestors10 generations back: 1 other ancestor K152968 · Arsenal Spinal Fixation System · Alphatec Spine, Inc. · 2015K143149 · Arsenal Spinal Fixation System · Alphatec Spine, Inc. · 2015K133221 · Arsenal Spinal Fixation System · Alphatec Spine, Inc. · 2014 · recalledK130646 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2013K113174 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2011 · recalledK112473 · CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2011K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010K091974 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2009 · recalledK091442 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2009K053101 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2006K052187 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K050809 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2005K043151 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K042025 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2004 · recalledK041118 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek · 2004K040583 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2004−15−10−50
  1. Root · 16 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 12 generations between
  3. 3 generations backK133221 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2014 · Recalled
  4. 2 generations backK143149 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015
  5. 1 generation backK152968 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015
  6. This deviceK180153 X-spine Cortical Bone Screw SystemX-Spine Systems, Inc. · 2018
Show all 16 generations
  1. Root · 16 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 15 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 14 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 13 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 12 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 11 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 10 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 9 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 8 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 7 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 6 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 5 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 4 generations backK130646 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
  14. 3 generations backK133221 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2014 · Recalled
  15. 2 generations backK143149 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015
  16. 1 generation backK152968 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015
  17. This deviceK180153 X-spine Cortical Bone Screw SystemX-Spine Systems, Inc. · 2018
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−16K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−15K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−14K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−13K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−12K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−11K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−10K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−9K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−8K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−7K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−6K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−5K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−4K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013—
−3K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20142
−2K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.2015—
−1K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.2015—
0 (this device)K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
199410
199530
199660
199730
199890
199930
2000150
2001170
2002100
2003140
2004220
2005200
2006130
2007120
2008140
2009100
201070
201170
201240
201310
201420
201520
FIG. 1 — Lineage of K180153, 2004–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K152132X-spine Pedicle Screw System
Summary page 5
…rpose for this submission is to submit a new medical device for review. VI. PREDICATE DEVICES Primary Predicate: • X-spine Pedicle Screw System (K152132) [Fortex®] Additional Predicates: • Arsenal Spinal Fixation System (K152968) [Alphatec Spine, Inc.] •…
X-Spine Systems, Inc.20151
*K152968Arsenal Spinal Fixation System
Summary page 5
…VICES Primary Predicate: • X-spine Pedicle Screw System (K152132) [Fortex®] Additional Predicates: • Arsenal Spinal Fixation System (K152968) [Alphatec Spine, Inc.] • Xia 4.5 Spinal System (K050461) [Stryker Spine] VII. INDICATIONS FOR USE The X-s…
Alphatec Spine, Inc.2015—
*K050461Xia 4.5 Spinal System
Summary page 5
…System (K152132) [Fortex®] Additional Predicates: • Arsenal Spinal Fixation System (K152968) [Alphatec Spine, Inc.] • Xia 4.5 Spinal System (K050461) [Stryker Spine] VII. INDICATIONS FOR USE The X-spine Cortical Bone Screw System is intended for posterior, non-cerv…
Stryker Spine2005—

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 14 years and passes through 5 companies; a new generation was cleared every 10 months on median.
  • 27 of the 213 ancestors have a recall of any class.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007: 382008: 362009: 442010: 372011: 482012: 602013: 352014: 462015: 552016: 502017: 632018: 562019: 392020: 482021: 322022: 342023: 442024: 392025: 242026 (partial year): 30
2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007: 87 days median2008: 59 days median2009: 71 days median2010: 111 days median2011: 84 days median2012: 79 days median2013: 73 days median2014: 90 days median2015: 90 days median2016: 84 days median2017: 69 days median2018: 61 days median2019: 84 days median2020: 68 days median2021: 61 days median2022: 88 days median2023: 72 days median2024: 57 days median2025: 61 days median2026 (partial year): 91 days median
2007high 111 (2010) · low 57 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NKB

1in 2025

2007: 42008: 52009: 332010: 42011: 32012: 132014: 3, 1 Class I2015: 32016: 12017: 12018: 32019: 12020: 12022: 52023: 22024: 32025: 12026 (partial year): 3
2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007: 342008: 822009: 1712010: 4622011: 5772012: 1,7472013: 1,9622014: 1,6712015: 1,4462016: 1,5852017: 1,6182018: 1,6842019: 1,9152020: 2,0762021: 1,7452022: 1,3392023: 9192024: 1,6142025: 1,171
2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20073887434
20083659582
2009447133171
2010371114462
201148843577
20126079131,747
2013357301,962
201446903 (1)1,671
2015559031,446
2016508411,585
2017636911,618
2018566131,684
2019398411,915
2020486812,076
2021326101,745
2022348851,339
202344722919
2024395731,614
2025246111,171
202630913—

What is it indicated for?

The X-spine Cortical Bone Screw System is intended for posterior, non-cervical pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine for the following indications: * Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the…

Read the full statement (149 words)

The X-spine Cortical Bone Screw System is intended for posterior, non-cervical pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine for the following indications:

* Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies

* Severe spondylolisthesis (Grades 3 and 4) of the L.5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion

* Spondylolisthesis

* Trauma (i.e. fracture or dislocation)

= Spinal stenosis

» Deformities or curvatures (i.e. scoliosis, kyphosis)

» Spinal tumor

» Pseudoarthrosis, and/or

* Failed previous fusion

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from X-Spine Systems, Inc.

34 FDA decisions under this applicant name. See the company

  • K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc. · 20181 recall
  • K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc. · 20171 recall
  • K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc. · 20171 recall
  • K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc. · 2017
  • K170224Spider Cervical Plating SystemX-Spine Systems, Inc. · 2017

Recent decisions in NKB

The NKB category page

  • K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. · 2026
  • K263062NOVIX Pedicle Screw SystemTdm Co., Ltd. · 2026
  • K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
  • K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc. · 2026
  • K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026

https://510kreport.com/device/K180153 · printed Nov 5, 2026

Cite this page

510(k) Report. “K180153: X-spine Cortical Bone Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180153

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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