510(k) Report

510(k) · Cleared

Cleared

CD HORIZON Spinal System

K143569510(k) TraditionalCleared Feb 12, 201558-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

Medtronic Sofamor Danek USA, Inc. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Feb 12, 2015 as substantially equivalent to K143141 (Medtronic Sofamor Danek USA, Inc., 2014) and 8 other predicates after a 58-day review. Its family tree reaches back 13 generations to 2004. 15 later devices descend from it.

Decided
Feb 12, 2015
Review
58 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
9

Its longest line of descent runs back 13 generations to K040583 (2004). 87 ancestors in all, the oldest K841189 (1984). 15 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2014: 2 other ancestors2013: 1 other ancestor2005: 10 other ancestors1996: 2 other ancestors2011: 1 other ancestor2010: 3 other ancestors2009: 1 other ancestor2008: 2 other ancestors2006: 5 other ancestors2004: 17 other ancestors2003: 6 other ancestors2002: 5 other ancestors2000: 6 other ancestors1999: 1 other ancestor2007: 3 other ancestors2001: 6 other ancestors1998: 2 other ancestors1984: 1 other ancestor2015: 2 descendants cleared2020: 2 descendants cleared2021: 2 descendants cleared2019: 2 descendants cleared2016: 1 descendant cleared2022: 2 descendants cleared2026: 2 descendants cleared2024: 1 descendant cleared2023: 1 descendant cleared×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) K132639 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 201319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 24 other ancestors3 generations back: 19 other ancestors4 generations back: 15 other ancestors5 generations back: 4 other ancestors6 generations back: 7 other ancestors 1 generation forward: 2 descendants2 generations forward: 5 descendants3 generations forward: 5 descendants4 generations forward: 2 descendants5 generations forward: 1 descendant K132639 · 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 · 2004−10−50+5
  1. Root · 13 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 9 generations between
  3. 3 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  4. 2 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  5. 1 generation backK132639 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
  6. This deviceK143569 CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
  7. Descendant · cites it directly · 12 of its ownK151196 Nautilus Spinal SystemLife Spine, Inc. · 2015
  8. Descendant · 2 generations on · 10 of its ownK191575 ARx Spinal SystemLife Spine, Inc. · 2019
  9. Descendant · 2 generations on · 9 of its ownK200070 ARx Spinal SystemLife Spine, Inc. · 2020
  10. Descendant · 3 generations on · 5 of its ownK203163 ARx Illiac Spinal Screw SystemLife Spine, Inc. · 2020
  11. Descendant · 2 generations on · 2 of its ownK183430 Modular Spinal Fixation SystemLife Spine, Inc. · 2019
Show all 13 generations
  1. Root · 13 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 12 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 11 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 10 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 9 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 8 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 7 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 6 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 5 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 4 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 3 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 2 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 1 generation backK132639 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
  14. This deviceK143569 CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2015: 22016: 12019: 22020: 22021: 22022: 22023: 12024: 12026: 2
2015high 2 (2015) · low 0 (2017)2026

Most influential descendants

Showing 5 of 15 · See all
  • K151196Nautilus Spinal SystemLife Spine, Inc. · 2015 · cites it directly12descendants
  • K191575ARx Spinal SystemLife Spine, Inc. · 2019 · 2 generations on10descendants
  • K200070ARx Spinal SystemLife Spine, Inc. · 2020 · 2 generations on9descendants
  • K203163ARx Illiac Spinal Screw SystemLife Spine, Inc. · 2020 · 3 generations on5descendants
  • K183430Modular Spinal Fixation SystemLife Spine, Inc. · 2019 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−12K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−11K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−10K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−9K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−8K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−7K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−6K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−5K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−4K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−3K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−2K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−1K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013—
0 (this device)K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015—
+1K151196Nautilus Spinal SystemLife Spine, Inc.2015—
+2K191575ARx Spinal SystemLife Spine, Inc.2019—
+2K200070ARx Spinal SystemLife Spine, Inc.2020—
+3K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.2020—
+2K183430Modular Spinal Fixation SystemLife Spine, Inc.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199620
199820
199910
200060
200160
200250
200360
2004170
2005100
200650
200730
200820
200910
201030
201110
201310
201420

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201520
201610
201920
202020
202120
202220
202310
202410
202620
FIG. 1 — Lineage of K143569, 2004–2026Source: 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? (9)

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
*K143141CD HORIZON Spinal System
Summary page 6
…CD HORIZON® Spinal System Primary Predicate: K143141 (S.E. 12/01/2014) Additional Predicates:…
Medtronic Sofamor Danek USA, Inc.2014—
*K132328CD Horizon Spinal System
Summary page 6
…K143141 (S.E. 12/01/2014) Additional Predicates: K132328 (S.E. 12/06/2013) K091974 (S.E. 09/02/2009)…
Medtronic Sofamor Danek USA, Inc.2013—
*K091974Modification to CD Horizon Spinal System
Summary page 6
…Additional Predicates: K132328 (S.E. 12/06/2013) K091974 (S.E. 09/02/2009) K113174 (S.E. 11/21/2011)…
Medtronic Sofamor Danek USA, Inc.20091
*K113174CD Horizon Spinal System
Summary page 6
…K132328 (S.E. 12/06/2013) K091974 (S.E. 09/02/2009) K113174 (S.E. 11/21/2011) K042025 (S.E. 08/25/2004)…
Medtronic Sofamor Danek USA, Inc.20111
*K042025Modification to CD Horizon Spinal System
Summary page 6
…K091974 (S.E. 09/02/2009) K113174 (S.E. 11/21/2011) K042025 (S.E. 08/25/2004) K961633 (S.E. 12/05/1996)…
Medtronic Sofamor Danek, Inc.20044
*K961633CD Horizon Spinal System
Summary page 6
…K113174 (S.E. 11/21/2011) K042025 (S.E. 08/25/2004) K961633 (S.E. 12/05/1996) K132639 (S.E. 11/25/2013)…
Sofamor Danek USA,Inc.1996—
*K132639CD Horizon Spinal System
Summary page 6
…K042025 (S.E. 08/25/2004) K961633 (S.E. 12/05/1996) K132639 (S.E. 11/25/2013) K141494 (S.E. 08/06/2014)…
Medtronic Sofamor Danek USA, Inc.2013—
*K141494CD Horizon Spinal System
Summary page 6
…K961633 (S.E. 12/05/1996) K132639 (S.E. 11/25/2013) K141494 (S.E. 08/06/2014) K050439 (S.E. 03/24/2005) …
Medtronic Sofamor Danek USA, Inc.2014—
*K050439CD Horizon Spinal System
Summary page 6
…K132639 (S.E. 11/25/2013) K141494 (S.E. 08/06/2014) K050439 (S.E. 03/24/2005)  The predicates have not been subject to a design related recall. IV.…
Medtronic Sofamor Danek, Inc.2005—

What descends from it? (15)

See all 15

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K151196Nautilus Spinal SystemLife Spine, Inc.201512
K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151

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 11 years and passes through 3 companies; a new generation was cleared every 4 months on median.
  • 11 of the 87 ancestors have a recall of any class.
  • Of its descendants, K151196 (Life Spine, Inc., 2015) has gone furthest, with 12 descendants of its own.

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. 2015, 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 CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion 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, or lordosis), tumor…

Read the full statement (342 words)

The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion 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, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.

With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD HORIZON® SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disc disease (as previously defined), spondylolisthesis, trauma, and/or tumor.

In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.

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

More from Medtronic Sofamor Danek USA, Inc.

366 FDA decisions under this applicant name. See the company

  • P000058/S095Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion DeviceMedtronic Sofamor Danek USA, Inc. · 2026
  • P000054/S075Infuse Bone GraftMedtronic Sofamor Danek USA, Inc. · 2026
  • P000058/S099Infuse TM Bone Graft/Medtronic lnterbody Fusion DeviceMedtronic Sofamor Danek USA, Inc. · 2026
  • P000054/S078Infuse™ Bone GraftMedtronic Sofamor Danek USA, Inc. · 2026
  • K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026

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/K143569 · printed Nov 5, 2026

Cite this page

510(k) Report. “K143569: CD HORIZON Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143569

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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