510(k) Report

510(k) · Cleared

Cleared

CD HORIZON™ Fenestrated Screw Set

K170347510(k) TraditionalCleared Apr 4, 201760-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 · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Apr 4, 2017 as substantially equivalent to K113174 (Medtronic Sofamor Danek USA, Inc., 2011) and 1 other predicate after a 60-day review. Its family tree reaches back 13 generations to 2004. 91 later devices descend from it.

Decided
Apr 4, 2017
Review
60 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
2

Its longest line of descent runs back 13 generations to K040583 (2004). 83 ancestors in all, the oldest K841189 (1984). 91 later devices descend from it, 9 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2015: 1 other ancestor2011: 2 other ancestors2004: 18 other ancestors2010: 2 other ancestors2009: 1 other ancestor2008: 2 other ancestors2006: 6 other ancestors2005: 9 other ancestors2003: 6 other ancestors2002: 5 other ancestors2000: 4 other ancestors1999: 1 other ancestor2007: 2 other ancestors1996: 1 other ancestor2001: 7 other ancestors1998: 2 other ancestors1984: 1 other ancestor2021: 6 descendants cleared2019: 4 descendants cleared2018: 2 descendants cleared2020: 9 descendants cleared2024: 17 descendants cleared2023: 13 descendants cleared2022: 6 descendants cleared2026: 21 descendants cleared2025: 13 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) K152604 · KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set · Medtronic Sofamor Danek USA, Incorporated · 201619801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 4 other ancestors3 generations back: 21 other ancestors4 generations back: 19 other ancestors5 generations back: 16 other ancestors6 generations back: 10 other ancestors 1 generation forward: 9 descendants2 generations forward: 19 descendants3 generations forward: 11 descendants4 generations forward: 15 descendants5 generations forward: 13 descendants6 generations forward: 15 descendants7 generations forward: 9 descendants K152604 · KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set · Medtronic Sofamor Danek USA, Incorporated · 2016K113174 · 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 backK152604 KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated · 2016
  6. This deviceK170347 CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA · 2017
  7. Descendant · cites it directly · 50 of its ownK191148 Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™…Medtronic Sofamor Danek USA, Inc. · 2019
  8. Descendant · cites it directly · 41 of its ownK193011 CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc. · 2020
  9. Descendant · cites it directly · 41 of its ownK173487 CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018
  10. Descendant · 2 generations on · 39 of its ownK182377 CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018
  11. Descendant · 2 generations on · 38 of its ownK201362 CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System…Medtronic · 2020
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 backK152604 KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated · 2016
  14. This deviceK170347 CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA · 2017

Showing 5 of 91 descendants. See all descendants

Descendants cleared per year

2018: 22019: 42020: 92021: 62022: 62023: 132024: 172025: 132026: 21
2018high 21 (2026) · low 2 (2018)2026

Most influential descendants

Showing 5 of 91 · See all
  • K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc. · 2019 · cites it directly50descendants
  • K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc. · 2020 · cites it directly41descendants
  • K173487CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018 · cites it directly41descendants
  • K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018 · 2 generations on39descendants
  • K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic · 2020 · 2 generations on38descendants
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
−1K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016—
0 (this device)K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA2017—
+1K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™…Medtronic Sofamor Danek USA, Inc.2019—
+1K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.2020—
+1K173487CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.2018—
+2K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.2018—
+2K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™…Medtronic2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199610
199820
199910
200040
200170
200250
200360
2004180
200590
200660
200720
200820
200910
201020
201120
201510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201820
201940
202090
202160
202260
2023130
2024170
2025130
2026210
FIG. 1 — Lineage of K170347, 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? (2)

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
*K113174CD Horizon Spinal System
Summary page 4
…ulation Number 21 CFR 888.3070 Thoracolumbosacral Pedicle Screw System Regulation Name and Device Product Classification Code Predicate Devices K113174 - CD HORIZON™ Spinal System (SE 11/21/11) Secondary Predicate K152604 – C…
Medtronic Sofamor Danek USA, Inc.20111
*K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set
Summary page 4
…sification Code Predicate Devices K113174 - CD HORIZON™ Spinal System (SE 11/21/11) Secondary Predicate K152604 – CD HORIZON™ Fenestrated Screw Set (SE 01/06/16) The predicate devices have not been subject to a de…
Medtronic Sofamor Danek USA, Incorporated2016—

Also cleared against K113174: 36 other devices →

What descends from it? (91)

See all 91

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

NumberDeviceApplicantDecidedDescendants
K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950
K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041
K173487CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201841
K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216
K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215
K203506PERLA® TL posterior osteosynthesis systemSpineart20213
K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242
K201648Sterispine™ PSSafe Orthopaedics20201
K183091Elaris Pedicle Screw SystemSpinewelding AG20190

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 13 years and passes through 5 companies; a new generation was cleared every 4 months on median.
  • 16 of the 83 ancestors have a recall of any class.
  • Of its descendants, K191148 (Medtronic Sofamor Danek USA, Inc., 2019) has gone furthest, with 50 descendants of its own.
  • 36 other devices also cite its predicate K113174.

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. 2017, 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?

When used without cement, the CD HORIZON Fenestrated Screws (with or without SEXTANT® or LONGITUDE® instrumentation) are 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…

Read the full statement (161 words)

When used without cement, the CD HORIZON Fenestrated Screws (with or without SEXTANT® or LONGITUDE® instrumentation) are 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), pseudarthrosis, and/or failed previous fusion.

When used in conjunction with KYPHON HV-RT™ Fenestrated Screw Bone Cement, the CD HORIZON™ Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CD HORIZON™ Fenestrated Screws augmented with KYPHON HV-RT™ Fenestrated Screw Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

Indications for use as stated in the FDA summary.

Also cleared against K113174

36 other devices cite the same predicate.

  • K252729Universal Spinal SystemDouble Medical Technology, Inc. · 2025
  • K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2025
  • K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc. · 2024
  • K223494CD Horizon Spinal SystemMedtronic · 2023
  • K221244CD Horizon™ Spinal SystemMedtronic · 2022
  • K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International · 2022

More from Medtronic Sofamor Danek USA

9 FDA decisions under this applicant name. See the company

  • K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
  • K133904CD Horizon Spinal System Growth Rod SetMedtronic Sofamor Danek USA · 2014
  • K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  • K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  • K123978Capstone L Spinal SystemMedtronic Sofamor Danek USA · 2013

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/K170347 · printed Nov 6, 2026

Cite this page

510(k) Report. “K170347: CD HORIZON™ Fenestrated Screw Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170347

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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