510(k) · Cleared
ClearedNuVasive Reline System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nu Vasive, Incorporated · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Apr 23, 2015 as substantially equivalent to K142499 (Nu Vasive, Incorporated, 2014) and 4 other predicates after a 120-day review. Its family tree reaches back 16 generations to 2004. 1 of the 224 devices in its family, counting itself, has a Class I recall. 77 later devices descend from it.
- Decided
- Apr 23, 2015
- Review
- 120 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 16 generations to K040583 (2004). 146 ancestors in all, the oldest K841189 (1984). 77 later devices descend from it, 2 citing it directly. 1 of the 224 devices in this family, counting this one, has a Class I recall.
- Root · 16 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 12 generations between
- 3 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 2 generations backK132111 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 1 generation backK141604 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- This deviceK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
- Descendant · cites it directly · 67 of its ownK160989 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
- Descendant · cites it directly · 48 of its ownK161014 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
- Descendant · 2 generations on · 41 of its ownK180498 NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated · 2018
- Descendant · 2 generations on · 39 of its ownK170126 NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated · 2017
- Descendant · 3 generations on · 28 of its ownK190526 High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd. · 2019
Show all 16 generations
- Root · 16 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 13 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 12 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 11 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 10 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 9 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 8 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 7 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 6 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 5 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 4 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 3 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 2 generations backK132111 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 1 generation backK141604 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- This deviceK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
Showing 5 of 77 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K100952 Modification to Synthes Matrix System2 generations back · 2010
Most influential descendants
Showing 5 of 77 · See all- K160989NuVasive® Reline® SystemNu Vasive, Incorporated · 2016 · cites it directly67descendants
- K161014NuVasive® Reline® SystemNu Vasive, Incorporated · 2016 · cites it directly48descendants
- K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated · 2018 · 2 generations on41descendants
- K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated · 2017 · 2 generations on39descendants
- K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd. · 2019 · 3 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −15 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −14 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −13 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −12 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −11 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −10 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −9 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −8 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −7 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −6 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −5 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −4 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −3 | K131321 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −2 | K132111 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −1 | K141604 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| 0 (this device) | K143684 | NuVasive Reline System | Nu Vasive, Incorporated | 2015 | — |
| +1 | K160989 | NuVasive® Reline® System | Nu Vasive, Incorporated | 2016 | — |
| +1 | K161014 | NuVasive® Reline® System | Nu Vasive, Incorporated | 2016 | — |
| +2 | K180498 | NuVasive Reline Fenestrated Screws, High V+ Bone Cement | Nu Vasive, Incorporated | 2018 | — |
| +2 | K170126 | NuVasive® Reline® 4.5-5.0 System | Nu Vasive, Incorporated | 2017 | — |
| +3 | K190526 | High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws | CarboFix Orthopedics, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 1999 | 3 | 0 |
| 2000 | 14 | 0 |
| 2001 | 10 | 0 |
| 2002 | 7 | 0 |
| 2003 | 11 | 0 |
| 2004 | 19 | 0 |
| 2005 | 13 | 0 |
| 2006 | 6 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 5 | 0 |
| 2010 | 5 | 1 |
| 2011 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 6 | 0 |
| 2020 | 4 | 0 |
| 2021 | 6 | 0 |
| 2022 | 6 | 0 |
| 2023 | 15 | 0 |
| 2024 | 11 | 0 |
| 2025 | 10 | 0 |
| 2026 | 13 | 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 NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K142499 | Reline SystemSummary page 5…NKB, OSH, MNI, MNH, KWQ,KWP C. Predicate Devices The subject device is substantially equivalent to the primary predicate device Reline System (K142499) and additional predicate devices, GSB Global Balance System (K132014), SpheRx II Pedicle Screw System (K091502), Synthes US… | 2014 |
| * | K132014 | GSB Global Spinal Balance SystemSummary page 5…The subject device is substantially equivalent to the primary predicate device Reline System (K142499) and additional predicate devices, GSB Global Balance System (K132014), SpheRx II Pedicle Screw System (K091502), Synthes USS Universal Spine System (K111358), and Medtronic CD HORIZON Spin… | 2013 |
| * | K091502 | Nuvasive Spherx II SystemSummary page 5…to the primary predicate device Reline System (K142499) and additional predicate devices, GSB Global Balance System (K132014), SpheRx II Pedicle Screw System (K091502), Synthes USS Universal Spine System (K111358), and Medtronic CD HORIZON Spinal System (K141604). D. Device Description… | 2009 |
| * | K111358 | Synthes UssSummary page 5…(K142499) and additional predicate devices, GSB Global Balance System (K132014), SpheRx II Pedicle Screw System (K091502), Synthes USS Universal Spine System (K111358), and Medtronic CD HORIZON Spinal System (K141604). D. Device Description The NuVasive Reline System is a pedicle screw sy… | 2011 |
| * | K141604 | CD Horizon Spinal SystemSummary page 5…lobal Balance System (K132014), SpheRx II Pedicle Screw System (K091502), Synthes USS Universal Spine System (K111358), and Medtronic CD HORIZON Spinal System (K141604). D. Device Description The NuVasive Reline System is a pedicle screw system that consists of a variety screws, hooks… | 2014 |
What descends from it? (77)
See all 772 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 5 companies; a new generation was cleared every 5 months on median.
- 21 of the 146 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K160989 (Nu Vasive, Incorporated, 2016) has gone furthest, with 67 descendants of its own.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
When used as a pedicle screw fixation system, the NuVasive Reline 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…
Read the full statement (319 words)
When used as a pedicle screw fixation system, the NuVasive Reline 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)
When used for posterior non-cervical screw fixation in pediatric patients, NuVasive Reline System implants are indicated
as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally the NuVasive Reline 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.
The NuVasive Reline 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 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
In order to achieve additional levels of fixation, the Reline System rods may be connected to the Armada System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143684 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143684: NuVasive Reline System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143684
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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