510(k) Report

510(k) · Cleared

Cleared

CD Horizon™ Spinal System

K210637510(k) TraditionalCleared Apr 30, 202158-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 · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Apr 30, 2021 as substantially equivalent to K201407 (Medtronic Sofamor Danek USA, Inc., 2020) and 10 other predicates after a 58-day review. Its family tree reaches back 21 generations to 2004. 34 later devices descend from it.

Decided
Apr 30, 2021
Review
58 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
11

Its longest line of descent runs back 21 generations to K040583 (2004). 190 ancestors in all, the oldest K841189 (1984). 34 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2021: 1 other ancestor2020: 2 other ancestors2018: 3 other ancestors2014: 4 other ancestors2011: 3 other ancestors2006: 10 other ancestors2019: 1 other ancestor2016: 2 other ancestors2015: 4 other ancestors2013: 5 other ancestors2012: 2 other ancestors2008: 5 other ancestors2004: 22 other ancestors2003: 8 other ancestors2002: 8 other ancestors2000: 11 other ancestors1999: 3 other ancestors2017: 3 other ancestors2010: 4 other ancestors2009: 2 other ancestors2005: 16 other ancestors2001: 10 other ancestors1997: 5 other ancestors1994: 4 other ancestors2007: 4 other ancestors1998: 6 other ancestors1996: 2 other ancestors1995: 7 other ancestors1988: 2 other ancestors1987: 1 other ancestor1992: 2 other ancestors1989: 1 other ancestor1986: 2 other ancestors1984: 2 other ancestors1985: 1 other ancestor1990: 1 other ancestor2022: 1 descendant cleared2021: 1 descendant cleared2026: 15 descendants cleared2025: 7 descendants cleared2024: 6 descendants cleared2023: 4 descendants 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) ×2: 2 generations cleared close together, K121680 (2012), K122862 (2012) K141605 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2014K143019 · CD HORIZON Spinal System, IPC POWEREASE System · Medtronic Sofamor Danek USA, Inc. · 2015K153463 · CD HORIZON Spinal System, IPC POWEREASE System · Medtronic Sofamor Danek USA, Inc. · 2015K170679 · CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems · Medtronic Sofamor Danek · 2017×2: 2 generations cleared close together, K191148 (2019), K193011 (2020) K201362 · CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement · Medtronic · 202019801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 28 other ancestors3 generations back: 38 other ancestors4 generations back: 40 other ancestors5 generations back: 28 other ancestors6 generations back: 21 other ancestors7 generations back: 7 other ancestors 1 generation forward: 7 descendants2 generations forward: 11 descendants3 generations forward: 9 descendants4 generations forward: 7 descendants K201362 · CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement · Medtronic · 2020K193011 · CD Horizon™ Fenestrated Screw Set · Medtronic Sofamor Danek USA, Inc. · 2020K191148 · Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set · Medtronic Sofamor Danek USA, Inc. · 2019K170679 · CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems · Medtronic Sofamor Danek · 2017K153463 · CD HORIZON Spinal System, IPC POWEREASE System · Medtronic Sofamor Danek USA, Inc. · 2015K143019 · CD HORIZON Spinal System, IPC POWEREASE System · Medtronic Sofamor Danek USA, Inc. · 2015K141605 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2014K122862 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012K121680 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012K113174 · 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 · 2004−20−15−10−50
  1. Root · 21 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 17 generations between
  3. 3 generations backK191148 Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™…Medtronic Sofamor Danek USA, Inc. · 2019
  4. 2 generations backK193011 CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc. · 2020
  5. 1 generation backK201362 CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System…Medtronic · 2020
  6. This deviceK210637 CD Horizon™ Spinal SystemMedtronic · 2021
  7. Descendant · cites it directly · 20 of its ownK221244 CD Horizon™ Spinal SystemMedtronic · 2022
  8. Descendant · cites it directly · 17 of its ownK223494 CD Horizon Spinal SystemMedtronic · 2023
  9. Descendant · cites it directly · 15 of its ownK211958 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2021
  10. Descendant · 2 generations on · 11 of its ownK223181 NuVasive Reline SystemNu Vasive, Incorporated · 2023
  11. Descendant · 3 generations on · 6 of its ownK232650 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2023
Show all 21 generations
  1. Root · 21 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 20 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 19 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 18 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 17 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 16 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 15 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 14 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 13 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 12 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 11 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 10 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 9 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 8 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  15. 7 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
  16. 6 generations backK143019 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
  17. 5 generations backK153463 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
  18. 4 generations backK170679 CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use…Medtronic Sofamor Danek · 2017
  19. 3 generations backK191148 Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™…Medtronic Sofamor Danek USA, Inc. · 2019
  20. 2 generations backK193011 CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc. · 2020
  21. 1 generation backK201362 CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System…Medtronic · 2020
  22. This deviceK210637 CD Horizon™ Spinal SystemMedtronic · 2021

Showing 5 of 34 descendants. See all descendants

Descendants cleared per year

2021: 12022: 12023: 42024: 62025: 72026: 15
2021high 15 (2026) · low 1 (2021)2026

Most influential descendants

Showing 5 of 34 · See all
  • K221244CD Horizon™ Spinal SystemMedtronic · 2022 · cites it directly20descendants
  • K223494CD Horizon Spinal SystemMedtronic · 2023 · cites it directly17descendants
  • K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2021 · cites it directly15descendants
  • K223181NuVasive Reline SystemNu Vasive, Incorporated · 2023 · 2 generations on11descendants
  • K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2023 · 3 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−21K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−20K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−19K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−18K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−17K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−16K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−15K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−14K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−13K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−12K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−11K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−10K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−9K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−8K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−7K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014—
−6K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.2015—
−5K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.2015—
−4K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the…Medtronic Sofamor Danek2017—
−3K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™…Medtronic Sofamor Danek USA, Inc.2019—
−2K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.2020—
−1K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™…Medtronic2020—
0 (this device)K210637CD Horizon™ Spinal SystemMedtronic2021—
+1K221244CD Horizon™ Spinal SystemMedtronic2022—
+1K223494CD Horizon Spinal SystemMedtronic2023—
+1K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2021—
+2K223181NuVasive Reline SystemNu Vasive, Incorporated2023—
+3K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198420
198510
198620
198710
198820
198910
199010
199220
199440
199570
199620
199750
199860
199930
2000110
2001100
200280
200380
2004220
2005160
2006100
200740
200850
200920
201040
201130
201220
201350
201440
201540
201620
201730
201830
201910
202020
202110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
202210
202340
202460
202570
2026150
FIG. 1 — Lineage of K210637, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (11)

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
*K201407CD Horizon™ Spinal System
Summary page 7
…& Accessories (Simple, Powered) HBE, 882.4310, Class II II. Predicate Devices: Primary Predicate: CD Horizon TM Spinal System (K201407, S.E. 09/10/2020) Additional Predicate: CD Horizon TM Spinal System (K061591, S.E. 09/08/2006) CD Horizon TM S…
Medtronic Sofamor Danek USA, Inc.2020—
*K061591Modification to CD Horizon Spinal System
Summary page 7
…Predicate Devices: Primary Predicate: CD Horizon TM Spinal System (K201407, S.E. 09/10/2020) Additional Predicate: CD Horizon TM Spinal System (K061591, S.E. 09/08/2006) CD Horizon TM Spinal System (K042025, S.E. 08/25/2004) CD Horizon TM Spinal System (K170679, S.E. 0…
Medtronic Sofamor Danek, Inc.2006—
*K042025Modification to CD Horizon Spinal System
Summary page 7
…TM Spinal System (K201407, S.E. 09/10/2020) Additional Predicate: CD Horizon TM Spinal System (K061591, S.E. 09/08/2006) CD Horizon TM Spinal System (K042025, S.E. 08/25/2004) CD Horizon TM Spinal System (K170679, S.E. 05/11/2017) CD Horizon TM Spinal System (K 13174, S.E. 1…
Medtronic Sofamor Danek, Inc.20044
*K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…
Summary page 7
…l Predicate: CD Horizon TM Spinal System (K061591, S.E. 09/08/2006) CD Horizon TM Spinal System (K042025, S.E. 08/25/2004) CD Horizon TM Spinal System (K170679, S.E. 05/11/2017) CD Horizon TM Spinal System (K 13174, S.E. 11/21/2011) CD Horizon TM Spinal System (K1111520, S.E.…
Medtronic Sofamor Danek2017—
*K113174CD Horizon Spinal System
Summary page 12
…owing FDA primary and additional predicates cleared in K201407 (09/10/2020), K061591 (S.E. 09/08/2006), K042025 (S.E. 08/25/2004), K170679 (S.E. 05/11/2017), K113174 (S.E. 11/21/2011), K111520 (S.E. 10/26/2011), K140454 (S.E. 05/22/2014), K182121 (S.E. 11/02/2018), K203291 (S.E. 12/08/202…
Medtronic Sofamor Danek USA, Inc.20111
*K111520Ipc Powerease System
Summary page 12
…ional predicates cleared in K201407 (09/10/2020), K061591 (S.E. 09/08/2006), K042025 (S.E. 08/25/2004), K170679 (S.E. 05/11/2017), K113174 (S.E. 11/21/2011), K111520 (S.E. 10/26/2011), K140454 (S.E. 05/22/2014), K182121 (S.E. 11/02/2018), K203291 (S.E. 12/08/2020), K201362 (S.E. 08/19/202…
Medtronic Xomed, Inc.20112
*K140454Navigated CD Horizon Solera Screwdriver/Taps
Summary page 7
…05/11/2017) CD Horizon TM Spinal System (K 13174, S.E. 11/21/2011) CD Horizon TM Spinal System (K1111520, S.E. 10/26/2011) CD Horizon TM Spinal System (K140454, S.E. 05/22/2014) CD Horizon TM Spinal System (K182121, S.E. 11/02/2018) CD Horizon TM Spinal System (K203291, S.E. 1…
Medtronic Sofamor Danek USA, Inc.20141
*K182121CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition
Summary page 7
…11/21/2011) CD Horizon TM Spinal System (K1111520, S.E. 10/26/2011) CD Horizon TM Spinal System (K140454, S.E. 05/22/2014) CD Horizon TM Spinal System (K182121, S.E. 11/02/2018) CD Horizon TM Spinal System (K203291, S.E. 12/08/2020)…
Medtronic Sofamor Danek USA, Inc.2018—
*K203291CD Horizon Spinal System Instruments
Summary page 7
…10/26/2011) CD Horizon TM Spinal System (K140454, S.E. 05/22/2014) CD Horizon TM Spinal System (K182121, S.E. 11/02/2018) CD Horizon TM Spinal System (K203291, S.E. 12/08/2020) K210…
Medtronic Sofamor Danek USA, Inc.2020—
*K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement
Summary page 8
…K210637 Page 2 of 7 CD Horizon TM Spinal System (K201362, S.E. 08/19/2020) CD Horizon TM Spinal System (K203678, S.E. 01/15/2021) These predicate devices have not been sub…
Medtronic2020—
*K203678CD HORIZON™ Spinal System
Summary page 8
…Page 2 of 7 CD Horizon TM Spinal System (K201362, S.E. 08/19/2020) CD Horizon TM Spinal System (K203678, S.E. 01/15/2021) These predicate devices have not been subject to a design-related recall. III. Device Description:…
Medtronic Sofamor Danek USA, Inc.2021—

Also cleared against K201407: 5 other devices →

What descends from it? (34)

See all 34

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

NumberDeviceApplicantDecidedDescendants
K221244CD Horizon™ Spinal SystemMedtronic202220
K223494CD Horizon Spinal SystemMedtronic202317
K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115
K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245
K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243
K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260
K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250

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 17 years and passes through 4 companies; a new generation was cleared every 7 months on median.
  • 27 of the 190 ancestors have a recall of any class.
  • Of its descendants, K221244 (Medtronic, 2022) has gone furthest, with 20 descendants of its own.
  • 5 other devices also cite its predicate K201407.

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. 2021, 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 HorizonTM Spinal System with or without SextantTM instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD - 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)…

Read the full statement (605 words)

The CD HorizonTM Spinal System with or without SextantTM instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD - 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 HorizonTM Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion.

With the exception of DDD, CD Horizonm LegacyTm 3.5mm rods and associated components may be used for indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, CD HorizonTM Spinal System titanium, cobalt chrome, and stainless steel 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 HorizonTM 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 HorizonTM PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 - Si) in skeletally mature patients. Devices are intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.

The CD HorizonTM SpireTM plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (TI-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: DDD, spondylolisthesis, trauma, and/or tumor.

To achieve additional levels of fixation, CD HorizonTM Spinal System rods may be connected to the VertexTM Reconstruction System with the VertexTm rod connector. Refer to the VertexTM Reconstruction System package insert for a list of VertexTM indications.

Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the StealthStationTM System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Navigated Reusable Instruments are also compatible with the IPCTM PowereaseTM System.

Do not implant the instruments.

The IPCTM System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.

The IPCTM PowereaseTM System is indicated for drilling, tapping and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in placement or cutting of screws, posts and rods.

Do not implant instruments.

Indications for use as stated in the FDA summary.

Also cleared against K201407

5 other devices cite the same predicate.

  • K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd. · 2023
  • K223494CD Horizon Spinal SystemMedtronic · 2023
  • K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™ SPINAL SYSTEM; CD…Medtronic Sofamor Danek USA, Inc. · 2022
  • K221244CD Horizon™ Spinal SystemMedtronic · 2022
  • K202771CD Horizon Spinal SystemMedtronic · 2020

More from Medtronic

262 FDA decisions under this applicant name. See the company

  • K261792DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart VentMedtronic · 2026
  • P100047/S241HeartWare® HVAD SystemMedtronic · 2026
  • P100047/S240HeartWare™ HVAD™ SystemMedtronic · 2026
  • P100047/S239HeartWare® Ventricular Assist SystemMedtronic · 2026
  • K253530Trexon™ Monofilament Synthetic Absorbable SutureMedtronic · 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/K210637 · printed Nov 4, 2026

Cite this page

510(k) Report. “K210637: CD Horizon™ Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210637

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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