510(k) Report

510(k) · Cleared

Cleared

NuVaisve® Reline® Cervical System

K191553510(k) TraditionalCleared Aug 14, 201963-day reviewClass II21 CFR 888.3075

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

Nu Vasive, Incorporated · NKG Posterior Cervical Screw System

Cleared on Aug 14, 2019 as substantially equivalent to K180198 (Nu Vasive, Incorporated, 2018) and 3 other predicates after a 63-day review. Its family tree reaches back 19 generations to 2004. 1 of the 332 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.

Decided
Aug 14, 2019
Review
63 days
Class
Class II
Product code
NKG
Recalls
None
Predicates
4

Its longest line of descent runs back 19 generations to K040583 (2004). 329 ancestors in all, the oldest K841189 (1984). 2 later devices descend from it, 2 citing it directly. 1 of the 332 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2010: 9 other ancestors, 1 with a Class I recall12007: 13 other ancestors2000: 23 other ancestors2015: 6 other ancestors2009: 8 other ancestors2008: 16 other ancestors1999: 14 other ancestors1998: 15 other ancestors1997: 11 other ancestors2016: 1 other ancestor2006: 15 other ancestors2004: 32 other ancestors2003: 21 other ancestors2002: 17 other ancestors2001: 25 other ancestors1985: 2 other ancestors2014: 6 other ancestors2013: 5 other ancestors2012: 1 other ancestor2011: 7 other ancestors2005: 24 other ancestors1996: 8 other ancestors1994: 5 other ancestors1995: 13 other ancestors1993: 2 other ancestors1988: 2 other ancestors1987: 1 other ancestor1992: 2 other ancestors1989: 1 other ancestor1986: 2 other ancestors1984: 2 other ancestors1990: 1 other ancestor2022: 2 descendants clearedReference device: K160989 · NuVasive® Reline® System · Nu Vasive, Incorporated · 2016Reference device: K170126 · NuVasive® Reline® 4.5-5.0 System · Nu Vasive, Incorporated · 2017Reference device: K091502 · Nuvasive Spherx II System · Nuvasive, Inc. · 2009Reference device: K122081 · Nuvasive Long Lateral Spinal System · Nuvasive, Inc. · 2013Reference device: K191169 · NuVasive® Camber Laminoplasty System · Nu Vasive, Incorporated · 2019Reference device: K182974 · NuVasive Reline System · Nu Vasive, Incorporated · 2019×7: 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 · 2015K161014 · NuVasive® Reline® System · Nu Vasive, Incorporated · 2016K180198 · NuVasive® VuePoint® II OCT System · Nu Vasive, Incorporated · 201819801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 11 other ancestors3 generations back: 13 other ancestors4 generations back: 12 other ancestors5 generations back: 27 other ancestors, 1 with a Class I recall16 generations back: 67 other ancestors7 generations back: 76 other ancestors8 generations back: 37 other ancestors9 generations back: 31 other ancestors10 generations back: 19 other ancestors11 generations back: 8 other ancestors12 generations back: 4 other ancestors13 generations back: 2 other ancestors 1 generation forward: 2 descendants K180198 · NuVasive® VuePoint® II OCT System · Nu Vasive, Incorporated · 2018K161014 · 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
  1. Root · 19 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 15 generations between
  3. 3 generations backK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
  4. 2 generations backK161014 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
  5. 1 generation backK180198 NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated · 2018
  6. This deviceK191553 NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated · 2019
  7. Descendant · cites it directly · 1 of its ownK213654 NuVasive Reline Cervical SystemNu Vasive, Incorporated · 2022
  8. Descendant · cites it directly · 0 of its ownK221388 NuVasive Reline Cervical SystemNu Vasive, Incorporated · 2022
Show all 19 generations
  1. Root · 19 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 18 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 17 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 16 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 15 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 14 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 13 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 12 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 11 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 10 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 9 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 8 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 7 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 6 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  15. 5 generations backK132111 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  16. 4 generations backK141604 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
  17. 3 generations backK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
  18. 2 generations backK161014 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
  19. 1 generation backK180198 NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated · 2018
  20. This deviceK191553 NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated · 2019

Class I recalls in this family

  • K100952 Modification to Synthes Matrix System5 generations back · 2010

Most influential descendants

Showing 2 of 2 · See all
  • K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated · 2022 · cites it directly1descendant
  • K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated · 2022 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−19K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−18K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−17K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−16K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−15K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−14K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−13K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−12K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−11K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−10K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−9K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−8K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−7K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−6K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
−5K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
−4K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014—
−3K143684NuVasive Reline SystemNu Vasive, Incorporated2015—
−2K161014NuVasive® Reline® SystemNu Vasive, Incorporated2016—
−1K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated2018—
0 (this device)K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated2019—
+1K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated2022—
+1K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198420
198520
198620
198710
198820
198910
199010
199220
199320
199450
1995130
199680
1997110
1998150
1999140
2000230
2001250
2002170
2003210
2004320
2005240
2006150
2007130
2008160
200980
201091
201170
201210
201350
201460
201560
201610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202220
FIG. 1 — Lineage of K191553, 2004–2022Source: 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 NKG device

  1. #1 K252327 CMORE® CT System; CMORE® CT System Navigated…score 19.6 · 22 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? (4)

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
*K180198NuVasive® VuePoint® II OCT System
Summary page 4
….3050) Regulatory Class: Class II C. Predicate Devices The subject device is substantially equivalent to the primary predicate VuePoint II OCT System (K180198). Additional predicates include VuePoint OCT System (K071435), VuePoint OCT System (K093319), and DePuy Summit OCT Spinal Sy…
Nu Vasive, Incorporated2018—
*K071435Nuvasive Oct System
Summary page 4
…es The subject device is substantially equivalent to the primary predicate VuePoint II OCT System (K180198). Additional predicates include VuePoint OCT System (K071435), VuePoint OCT System (K093319), and DePuy Summit OCT Spinal System (K002733). Reference devices include NuVasive Relin…
Nuvasive, Inc.2007—
*K093319Nuvasive Vuepoint Oct System
Summary page 4
…ntially equivalent to the primary predicate VuePoint II OCT System (K180198). Additional predicates include VuePoint OCT System (K071435), VuePoint OCT System (K093319), and DePuy Summit OCT Spinal System (K002733). Reference devices include NuVasive Reline System (K160989), NuVasive Reline…
Nuvasive, Inc.2010—
*K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal System
Summary page 4
…ePoint II OCT System (K180198). Additional predicates include VuePoint OCT System (K071435), VuePoint OCT System (K093319), and DePuy Summit OCT Spinal System (K002733). Reference devices include NuVasive Reline System (K160989), NuVasive Reline 4.5-5.0 System (K170126), NuVasive SpheRx…
Depuyacromed2000—
†K160989NuVasive® Reline® SystemNu Vasive, Incorporated2016—
†K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated2017—
†K091502Nuvasive Spherx II SystemNuvasive, Inc.2009—
†K122081Nuvasive Long Lateral Spinal SystemNuvasive, Inc.2013—
†K191169NuVasive® Camber Laminoplasty SystemNu Vasive, Incorporated2019—
†K182974NuVasive Reline SystemNu Vasive, Incorporated2019—

Also cleared against K180198: 2 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221
K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220

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 · 5 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 15 years and passes through 5 companies; a new generation was cleared every 6 months on median.
  • 38 of the 329 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K213654 (Nu Vasive, Incorporated, 2022) has gone furthest, with 1 descendant of its own.
  • 2 other devices also cite its predicate K180198.

How does its category compare?

All NKG devices

NKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · NKG

6in 2025

2015: 172016: 162017: 152018: 122019: 82020: 142021: 72022: 72023: 102024: 32025: 62026 (partial year): 4
2007high 17 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKG

58in 2025

2015: 71 days median2016: 87 days median2017: 108 days median2018: 61 days median2019: 50 days median2020: 59 days median2021: 56 days median2022: 108 days median2023: 58 days median2024: 100 days median2025: 58 days median2026 (partial year): 169 days median
2007high 169 (2026) · low 50 (2019)2026

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

Recalls per year · NKG

2in 2020

2018: 12019: 12020: 2
2007high 2 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NKG

153in 2025

2015: 42016: 732017: 992018: 1272019: 2142020: 2362021: 7042022: 1752023: 1312024: 2062025: 153
2007high 704 (2021) · low 0 (2007)2025

MAUDE reports naming product code NKG, 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
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
2015177104
20161687073
201715108099
201812611127
20198501214
202014592236
20217560704
202271080175
202310580131
202431000206
20256580153
202641690—

What is it indicated for?

The NuVasive Reline Cervical System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and…

Read the full statement (179 words)

The NuVasive Reline Cervical System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Reline Cervical System is also 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 cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Reline Cervical System may be connected to the NuVasive® SpheRx® Spinal System, Precept® Spinal System, Armada® Spinal System, Reline®System and Reline® 4.5-5.0 System via the rod to rod connectors or transition rods.

Indications for use as stated in the FDA summary.

Also cleared against K180198

2 other devices cite the same predicate.

  • K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated · 2022
  • K211993Z-LINKPC SystemZavation Medical Products, LLC · 2021

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 NKG

The NKG category page

  • K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd. · 2026
  • K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd. · 2026
  • K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd. · 2026
  • K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc. · 2026
  • K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG · 2025

https://510kreport.com/device/K191553 · printed Nov 6, 2026

Cite this page

510(k) Report. “K191553: NuVaisve® Reline® Cervical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191553

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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