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 Jan 11, 2023 as substantially equivalent to K211958 (Medtronic Sofamor Danek USA, Inc., 2021) and 2 other predicates after a 92-day review. Its family tree reaches back 23 generations to 2004. 1 of the 385 devices in its family, counting itself, has a Class I recall. 11 later devices descend from it.
- Decided
- Jan 11, 2023
- Review
- 92 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 23 generations to K040583 (2004). 373 ancestors in all, the oldest K841189 (1984). 11 later devices descend from it, 3 citing it directly. 1 of the 385 devices in this family, counting this one, has a Class I recall.
- Root · 23 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 19 generations between
- 3 generations backK201362 CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System…Medtronic · 2020
- 2 generations backK210637 CD Horizon™ Spinal SystemMedtronic · 2021
- 1 generation backK211958 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2021
- This deviceK223181 NuVasive Reline SystemNu Vasive, Incorporated · 2023
- Descendant · cites it directly · 6 of its ownK232650 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2023
- Descendant · 2 generations on · 4 of its ownK251804 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2025
- Descendant · 2 generations on · 2 of its ownK253990 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
- Descendant · 2 generations on · 2 of its ownK253721 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2025
- Descendant · cites it directly · 2 of its ownK241519 Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc. · 2024
Show all 23 generations
- Root · 23 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 22 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 21 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 20 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 19 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 18 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 17 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 16 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 15 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 14 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 13 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 12 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 11 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 10 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 9 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 8 generations backK143019 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 7 generations backK153463 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 6 generations backK170679 CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use…Medtronic Sofamor Danek · 2017
- 5 generations backK191148 Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™…Medtronic Sofamor Danek USA, Inc. · 2019
- 4 generations backK193011 CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc. · 2020
- 3 generations backK201362 CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System…Medtronic · 2020
- 2 generations backK210637 CD Horizon™ Spinal SystemMedtronic · 2021
- 1 generation backK211958 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2021
- This deviceK223181 NuVasive Reline SystemNu Vasive, Incorporated · 2023
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K100952 Modification to Synthes Matrix System6 generations back · 2010
Most influential descendants
Showing 5 of 11 · See all- K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2023 · cites it directly6descendants
- K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2025 · 2 generations on4descendants
- K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026 · 2 generations on2descendants
- K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2025 · 2 generations on2descendants
- K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc. · 2024 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −22 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −21 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −20 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −19 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −18 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −17 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −16 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −15 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −14 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −13 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −12 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −11 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −10 | K122862 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −9 | K141605 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| −8 | K143019 | CD HORIZON Spinal System, IPC POWEREASE System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −7 | K153463 | CD HORIZON Spinal System, IPC POWEREASE System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −6 | K170679 | CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the… | Medtronic Sofamor Danek | 2017 | — |
| −5 | K191148 | Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™… | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| −4 | K193011 | CD Horizon™ Fenestrated Screw Set | Medtronic Sofamor Danek USA, Inc. | 2020 | — |
| −3 | K201362 | CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™… | Medtronic | 2020 | — |
| −2 | K210637 | CD Horizon™ Spinal System | Medtronic | 2021 | — |
| −1 | K211958 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| 0 (this device) | K223181 | NuVasive Reline System | Nu Vasive, Incorporated | 2023 | — |
| +1 | K232650 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2023 | — |
| +2 | K251804 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2025 | — |
| +2 | K253990 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026 | — |
| +2 | K253721 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2025 | — |
| +1 | K241519 | Invictus® Small Stature Spinal Fixation System | Alphatec Spine, Inc. | 2024 | — |
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 | 10 | 0 |
| 1998 | 15 | 0 |
| 1999 | 14 | 0 |
| 2000 | 23 | 0 |
| 2001 | 26 | 0 |
| 2002 | 16 | 0 |
| 2003 | 21 | 0 |
| 2004 | 36 | 0 |
| 2005 | 27 | 0 |
| 2006 | 19 | 0 |
| 2007 | 14 | 0 |
| 2008 | 15 | 0 |
| 2009 | 10 | 0 |
| 2010 | 10 | 1 |
| 2011 | 9 | 0 |
| 2012 | 3 | 0 |
| 2013 | 9 | 0 |
| 2014 | 8 | 0 |
| 2015 | 7 | 0 |
| 2016 | 5 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 6 | 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? (3)
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 |
|---|---|---|---|
| * | K211958 | CD Horizon Spinal SystemSummary page 5…NKB, KWP, KWQ C. Predicate Devices The subject device is substantially equivalent to the primary predicate device CD Horizon™ Spinal System (K211958) and additional predicate devices, NuVasive Reline 4.5-5.0 System (K190636) and GSB Global Spinal Balance System (K132014).… | 2021 |
| * | K190636 | NuVasive® Reline® 4.5-5.0 SystemSummary page 5…substantially equivalent to the primary predicate device CD Horizon™ Spinal System (K211958) and additional predicate devices, NuVasive Reline 4.5-5.0 System (K190636) and GSB Global Spinal Balance System (K132014). D. Device Description The NuVasive Reline System is a pedicle screw syste… | 2019 |
| * | K132014 | GSB Global Spinal Balance SystemSummary page 5…ate device CD Horizon™ Spinal System (K211958) and additional predicate devices, NuVasive Reline 4.5-5.0 System (K190636) and GSB Global Spinal Balance System (K132014). D. Device Description The NuVasive Reline System is a pedicle screw system that consists of a variety of screws, ho… | 2013 |
What descends from it? (11)
See all 113 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 · 6 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 7 months on median.
- 44 of the 373 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K232650 (S.M.A.I.O, 2023) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K211958.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 in skeletally mature patients, the NuVasive Reline System is intended to provide immobilization and stabilization of spinal segments 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 (335 words)
When used as a pedicle screw fixation system in skeletally mature patients, the NuVasive Reline System is intended to provide immobilization and stabilization of spinal segments 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 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. Pseudoarthrosis
7. Tumor resection and/or
8. Failed previous fusion
When used for posterior non-cervical screw fixation in pediatric patients, NuVasive Reline System is indicated as an adjunct to fusion to treat:
1. adolescent idiopathic scoliosis.
2. progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including infantile and juvenile idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis,
3. spondylolisthesis,
4. spondylolysis,
5. pseudarthrosis,
6. failed prior fusion and
7. fracture caused by tumor and/or trauma in pediatric patients.
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 System rods may be connected to the Armada System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223181: 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/K223181
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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