510(k) · Cleared
ClearedNuVasive Reline Cervical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nu Vasive, Incorporated · NKG Posterior Cervical Screw System
Cleared on Sep 9, 2022 as substantially equivalent to K213654 (Nu Vasive, Incorporated, 2022) and 1 other predicate after a 119-day review. Its family tree reaches back 21 generations to 2004. 1 of the 332 devices in its family, counting itself, has a Class I recall.
- Decided
- Sep 9, 2022
- Review
- 119 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 21 generations to K040583 (2004). 331 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet. 1 of the 332 devices in this family, counting this one, has a Class I recall.
- Root · 21 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 17 generations between
- 3 generations backK180198 NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated · 2018
- 2 generations backK191553 NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated · 2019
- 1 generation backK213654 NuVasive Reline Cervical SystemNu Vasive, Incorporated · 2022
- This deviceK221388 NuVasive Reline Cervical SystemNu Vasive, Incorporated · 2022
Show all 21 generations
- Root · 21 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 20 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 19 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 18 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 17 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 16 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 15 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 14 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 13 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 12 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 11 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 10 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 9 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 8 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 7 generations backK132111 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 6 generations backK141604 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 5 generations backK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
- 4 generations backK161014 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
- 3 generations backK180198 NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated · 2018
- 2 generations backK191553 NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated · 2019
- 1 generation backK213654 NuVasive Reline Cervical SystemNu Vasive, Incorporated · 2022
- This deviceK221388 NuVasive Reline Cervical SystemNu Vasive, Incorporated · 2022
Class I recalls in this family
- K100952 Modification to Synthes Matrix System6 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −20 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −19 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −18 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −17 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −16 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −15 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −14 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −13 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −12 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −11 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −10 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −9 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −8 | K131321 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −7 | K132111 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −6 | K141604 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| −5 | K143684 | NuVasive Reline System | Nu Vasive, Incorporated | 2015 | — |
| −4 | K161014 | NuVasive® Reline® System | Nu Vasive, Incorporated | 2016 | — |
| −3 | K180198 | NuVasive® VuePoint® II OCT System | Nu Vasive, Incorporated | 2018 | — |
| −2 | K191553 | NuVaisve® Reline® Cervical System | Nu Vasive, Incorporated | 2019 | — |
| −1 | K213654 | NuVasive Reline Cervical System | Nu Vasive, Incorporated | 2022 | — |
| 0 (this device) | K221388 | NuVasive Reline Cervical System | Nu Vasive, Incorporated | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 2 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 13 | 0 |
| 1996 | 8 | 0 |
| 1997 | 11 | 0 |
| 1998 | 15 | 0 |
| 1999 | 14 | 0 |
| 2000 | 23 | 0 |
| 2001 | 25 | 0 |
| 2002 | 17 | 0 |
| 2003 | 21 | 0 |
| 2004 | 32 | 0 |
| 2005 | 24 | 0 |
| 2006 | 15 | 0 |
| 2007 | 13 | 0 |
| 2008 | 16 | 0 |
| 2009 | 8 | 0 |
| 2010 | 9 | 1 |
| 2011 | 7 | 0 |
| 2012 | 1 | 0 |
| 2013 | 5 | 0 |
| 2014 | 6 | 0 |
| 2015 | 6 | 0 |
| 2016 | 1 | 0 |
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 K252327 CMORE® CT System; CMORE® CT System Navigated…score 19.6 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K213654 | NuVasive Reline Cervical SystemSummary page 4…uct Code: NKG, KWP C. Predicate Devices The subject device is substantially equivalent to the primary predicate Reline Cervical System (K213654) and additional predicate Reline Cervical System (K191553). D. Device Description The NuVasive Reline Cervical System is… | 2022 |
| * | K191553 | NuVaisve® Reline® Cervical SystemSummary page 4…ces The subject device is substantially equivalent to the primary predicate Reline Cervical System (K213654) and additional predicate Reline Cervical System (K191553). D. Device Description The NuVasive Reline Cervical System is an occipito-cervico-thoracic posterior system manufac… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 6 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 7 months on median.
- 38 of the 331 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All NKG devicesNKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · NKG
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKG
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKG
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NKG
153in 2025
MAUDE reports naming product code NKG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 17 | 71 | 0 | 4 |
| 2016 | 16 | 87 | 0 | 73 |
| 2017 | 15 | 108 | 0 | 99 |
| 2018 | 12 | 61 | 1 | 127 |
| 2019 | 8 | 50 | 1 | 214 |
| 2020 | 14 | 59 | 2 | 236 |
| 2021 | 7 | 56 | 0 | 704 |
| 2022 | 7 | 108 | 0 | 175 |
| 2023 | 10 | 58 | 0 | 131 |
| 2024 | 3 | 100 | 0 | 206 |
| 2025 | 6 | 58 | 0 | 153 |
| 2026 | 4 | 169 | 0 | — |
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 (180 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.
https://510kreport.com/device/K221388 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221388: NuVasive 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/K221388
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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