510(k) Report

510(k) · Cleared

Cleared

NuVasive® Reline® 4.5-5.0 System

K170126510(k) TraditionalCleared Mar 9, 201755-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

Nu Vasive, Incorporated · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Mar 9, 2017 as substantially equivalent to K160989 (Nu Vasive, Incorporated, 2016) and 5 other predicates after a 55-day review. Its family tree reaches back 18 generations to 2004. 1 of the 367 devices in its family, counting itself, has a Class I recall. 39 later devices descend from it.

Decided
Mar 9, 2017
Review
55 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
6

Its longest line of descent runs back 18 generations to K040583 (2004). 327 ancestors in all, the oldest K841189 (1984). 39 later devices descend from it, 3 citing it directly. 1 of the 367 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2016: 2 other ancestors2013: 5 other ancestors2009: 9 other ancestors2008: 15 other ancestors2006: 17 other ancestors2011: 8 other ancestors2007: 13 other ancestors2005: 25 other ancestors2004: 33 other ancestors2003: 21 other ancestors2001: 25 other ancestors1998: 15 other ancestors1997: 10 other ancestors1994: 5 other ancestors2015: 2 other ancestors2014: 6 other ancestors2012: 1 other ancestor2002: 16 other ancestors2000: 23 other ancestors1999: 14 other ancestors1996: 8 other ancestors2010: 8 other ancestors, 1 with a Class I recall11995: 13 other ancestors1984: 2 other ancestors1993: 2 other ancestors1988: 2 other ancestors1987: 1 other ancestor1992: 2 other ancestors1989: 1 other ancestor1986: 2 other ancestors1985: 2 other ancestors1990: 1 other ancestor2019: 4 descendants cleared2023: 8 descendants cleared2020: 3 descendants cleared2021: 4 descendants cleared2025: 4 descendants cleared2022: 3 descendants cleared2026: 11 descendants cleared2024: 2 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) K121680 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012×2: 2 generations cleared close together, K131321 (2013), K132111 (2013) K141604 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2014K143684 · NuVasive Reline System · Nu Vasive, Incorporated · 2015K160989 · NuVasive® Reline® System · Nu Vasive, Incorporated · 201619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 19 other ancestors3 generations back: 35 other ancestors4 generations back: 47 other ancestors, 1 with a Class I recall15 generations back: 52 other ancestors6 generations back: 56 other ancestors7 generations back: 28 other ancestors8 generations back: 32 other ancestors9 generations back: 21 other ancestors10 generations back: 8 other ancestors11 generations back: 4 other ancestors12 generations back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 8 descendants3 generations forward: 11 descendants4 generations forward: 14 descendants5 generations forward: 2 descendants6 generations forward: 1 descendant K160989 · NuVasive® Reline® System · Nu Vasive, Incorporated · 2016K143684 · NuVasive Reline System · Nu Vasive, Incorporated · 2015K141604 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2014K132111 · CD Horizon Spinal System · Medtronic Sofamor Danek USA · 2013K131321 · CD Horizon Spinal System · Medtronic Sofamor Danek USA · 2013K121680 · 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 · 2004−15−10−50+5
  1. Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 14 generations between
  3. 3 generations backK141604 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
  4. 2 generations backK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
  5. 1 generation backK160989 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
  6. This deviceK170126 NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated · 2017
  7. Descendant · cites it directly · 13 of its ownK190636 NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated · 2019
  8. Descendant · cites it directly · 13 of its ownK190360 LineSider™ Spinal SystemIntegrity Implants, Inc. · 2019
  9. Descendant · 2 generations on · 11 of its ownK223181 NuVasive Reline SystemNu Vasive, Incorporated · 2023
  10. Descendant · cites it directly · 11 of its ownK182974 NuVasive Reline SystemNu Vasive, Incorporated · 2019
  11. Descendant · 2 generations on · 10 of its ownK191575 ARx Spinal SystemLife Spine, Inc. · 2019
Show all 18 generations
  1. Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 17 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 16 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 15 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 14 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 13 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 12 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 11 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 10 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 9 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 8 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 7 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 6 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 5 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  15. 4 generations backK132111 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  16. 3 generations backK141604 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
  17. 2 generations backK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
  18. 1 generation backK160989 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
  19. This deviceK170126 NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated · 2017

Showing 5 of 39 descendants. See all descendants

Descendants cleared per year

2019: 42020: 32021: 42022: 32023: 82024: 22025: 42026: 11
2019high 11 (2026) · low 2 (2024)2026

Class I recalls in this family

  • K100952 Modification to Synthes Matrix System4 generations back · 2010

Most influential descendants

Showing 5 of 39 · See all
  • K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated · 2019 · cites it directly13descendants
  • K190360LineSider™ Spinal SystemIntegrity Implants, Inc. · 2019 · cites it directly13descendants
  • K223181NuVasive Reline SystemNu Vasive, Incorporated · 2023 · 2 generations on11descendants
  • K182974NuVasive Reline SystemNu Vasive, Incorporated · 2019 · cites it directly11descendants
  • K191575ARx Spinal SystemLife Spine, Inc. · 2019 · 2 generations on10descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−18K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−17K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−16K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−15K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−14K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−13K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−12K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−11K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−10K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−9K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−8K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−7K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−6K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−5K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
−4K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
−3K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014—
−2K143684NuVasive Reline SystemNu Vasive, Incorporated2015—
−1K160989NuVasive® Reline® SystemNu Vasive, Incorporated2016—
0 (this device)K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated2017—
+1K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated2019—
+1K190360LineSider™ Spinal SystemIntegrity Implants, Inc.2019—
+2K223181NuVasive Reline SystemNu Vasive, Incorporated2023—
+1K182974NuVasive Reline SystemNu Vasive, Incorporated2019—
+2K191575ARx Spinal SystemLife Spine, Inc.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198420
198520
198620
198710
198820
198910
199010
199220
199320
199450
1995130
199680
1997100
1998150
1999140
2000230
2001250
2002160
2003210
2004330
2005250
2006170
2007130
2008150
200990
201081
201180
201210
201350
201460
201520
201620

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201940
202030
202140
202230
202380
202420
202540
2026110
FIG. 1 — Lineage of K170126, 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.

1 device in this family has a Class I recall. 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? (6)

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
*K160989NuVasive® Reline® System
Summary page 5
…NKB, KWP, KWQ C. Predicate Devices The subject device is substantially equivalent to the primary predicate device NuVasive Reline System (K160989) and additional predicate devices, NuVasive Reline (K161014), NuVasive GSB Global Spinal Balance System (K132014), NuVasive…
Nu Vasive, Incorporated2016—
*K161014NuVasive® Reline® System
Summary page 5
…The subject device is substantially equivalent to the primary predicate device NuVasive Reline System (K160989) and additional predicate devices, NuVasive Reline (K161014), NuVasive GSB Global Spinal Balance System (K132014), NuVasive SpheRx II System (K062317), DePuy Spine Expedium Spine…
Nu Vasive, Incorporated2016—
*K132014GSB Global Spinal Balance System
Summary page 5
…imary predicate device NuVasive Reline System (K160989) and additional predicate devices, NuVasive Reline (K161014), NuVasive GSB Global Spinal Balance System (K132014), NuVasive SpheRx II System (K062317), DePuy Spine Expedium Spine System (K090230), and Medtronic CD HORIZON Spinal Sys…
Nuvasive, Inc.2013—
*K062317Modification to Nuvasive Spherx II System
Summary page 5
…e System (K160989) and additional predicate devices, NuVasive Reline (K161014), NuVasive GSB Global Spinal Balance System (K132014), NuVasive SpheRx II System (K062317), DePuy Spine Expedium Spine System (K090230), and Medtronic CD HORIZON Spinal System (K082236). D. Device Description…
Nuvasive, Inc.2006—
*K090230Expedium Spine System
Summary page 5
…evices, NuVasive Reline (K161014), NuVasive GSB Global Spinal Balance System (K132014), NuVasive SpheRx II System (K062317), DePuy Spine Expedium Spine System (K090230), and Medtronic CD HORIZON Spinal System (K082236). D. Device Description The NuVasive Reline 4.5-5.0 System is a ped…
Depuy Spine, Inc.2009—
*K082236CD Horizon Spinal System
Summary page 5
…obal Spinal Balance System (K132014), NuVasive SpheRx II System (K062317), DePuy Spine Expedium Spine System (K090230), and Medtronic CD HORIZON Spinal System (K082236). D. Device Description The NuVasive Reline 4.5-5.0 System is a pedicle screw system that consists of a variety screw…
Medtronic Sofamor Danek2008—

Also cleared against K160989: 3 other devices →

What descends from it? (39)

See all 39

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

NumberDeviceApplicantDecidedDescendants
K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913
K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913
K182974NuVasive Reline SystemNu Vasive, Incorporated201911

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 4 generations back · ◆ in the 2010 ancestors bar of FIG. 11 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 6 months on median.
  • 38 of the 327 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K190636 (Nu Vasive, Incorporated, 2019) has gone furthest, with 13 descendants of its own.
  • 3 other devices also cite its predicate K160989.

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 as a pedicle screw fixation system, the NuVasive Reline 4.5-5.0 System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine: 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed…

Read the full statement (324 words)

When used as a pedicle screw fixation system, the NuVasive Reline 4.5-5.0 System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine:

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

2. Degenerative spondylolisthesis with objective evidence of neurologic impairment

3. Fracture

4. Dislocation

5. Scoliosis

6. Kyphosis

7. Spinal tumor and/or

8. Failed previous fusion (pseudoarthrosis)

The NuVasive Reline 4.5-5.0 System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Reline 4.5-5.0 System is also intended for the following indications:

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

2. Spinal stenosis

3. Spondylolisthesis

4. Spinal deformities

5. Fracture

6. Pseudoarthosis

7. Tumor resection and/or

8. Failed previous fusion

When used for posterior non-cervical screw fixation in pediatric patients, NuVasive Reline 4.5-5.0 System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally the NuVasive Reline 4.5-5.0 System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis, spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.

In order to achieve additional levels of fixation, the NuVasive Reline 4.5-5.0 System rods may be connected to the Reline System.

Indications for use as stated in the FDA summary.

Also cleared against K160989

3 other devices cite the same predicate.

  • K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG · 2021
  • K182974NuVasive Reline SystemNu Vasive, Incorporated · 2019
  • K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated · 2018

More from Nu Vasive, Incorporated

112 FDA decisions under this applicant name. See the company

  • K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent…Nu Vasive, Incorporated · 2023
  • K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated · 2023
  • K230989Rod Registration FrameNu Vasive, Incorporated · 2023
  • K223181NuVasive Reline SystemNu Vasive, Incorporated · 2023
  • K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated · 2022

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/K170126 · printed Nov 6, 2026

Cite this page

510(k) Report. “K170126: NuVasive® Reline® 4.5-5.0 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170126

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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