510(k) · Cleared
ClearedKHEIRON® Spinal Fixation System, including patient specific K-ROD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
S.M.A.I.O · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Sep 29, 2023 as substantially equivalent to K211981 (S.M.A.I.O, 2022) and 1 other predicate after a 29-day review. Its family tree reaches back 24 generations to 2004. 1 of the 423 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it.
- Decided
- Sep 29, 2023
- Review
- 29 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 24 generations to K040583 (2004). 416 ancestors in all, the oldest K781443 (1978). 6 later devices descend from it, 6 citing it directly. 1 of the 423 devices in this family, counting this one, has a Class I recall.
- Root · 24 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 20 generations between
- 3 generations backK210637 CD Horizon™ Spinal SystemMedtronic · 2021
- 2 generations backK211958 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2021
- 1 generation backK223181 NuVasive Reline SystemNu Vasive, Incorporated · 2023
- This deviceK232650 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2023
- Descendant · cites it directly · 4 of its ownK251804 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2025
- Descendant · cites it directly · 2 of its ownK253990 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
- Descendant · cites it directly · 2 of its ownK253721 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2025
- Descendant · cites it directly · 1 of its ownK260786 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
- Descendant · cites it directly · 0 of its ownK262828 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
Show all 24 generations
- Root · 24 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 23 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 22 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 21 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 20 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 19 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 18 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 17 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 16 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 15 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 14 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 13 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 12 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 11 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 10 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 9 generations backK143019 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 8 generations backK153463 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 7 generations backK170679 CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use…Medtronic Sofamor Danek · 2017
- 6 generations backK191148 Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™…Medtronic Sofamor Danek USA, Inc. · 2019
- 5 generations backK193011 CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc. · 2020
- 4 generations backK201362 CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System…Medtronic · 2020
- 3 generations backK210637 CD Horizon™ Spinal SystemMedtronic · 2021
- 2 generations backK211958 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2021
- 1 generation backK223181 NuVasive Reline SystemNu Vasive, Incorporated · 2023
- This deviceK232650 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K100952 Modification to Synthes Matrix System7 generations back · 2010
Most influential descendants
Showing 5 of 6 · See all- K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2025 · cites it directly4descendants
- K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026 · cites it directly2descendants
- K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2025 · cites it directly2descendants
- K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026 · cites it directly1descendant
- K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −24 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −23 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −22 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −21 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −20 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −19 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −18 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −17 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −16 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −15 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −14 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −13 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −12 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −11 | K122862 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −10 | K141605 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| −9 | K143019 | CD HORIZON Spinal System, IPC POWEREASE System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −8 | K153463 | CD HORIZON Spinal System, IPC POWEREASE System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −7 | K170679 | CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the… | Medtronic Sofamor Danek | 2017 | — |
| −6 | K191148 | Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™… | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| −5 | K193011 | CD Horizon™ Fenestrated Screw Set | Medtronic Sofamor Danek USA, Inc. | 2020 | — |
| −4 | K201362 | CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™… | Medtronic | 2020 | — |
| −3 | K210637 | CD Horizon™ Spinal System | Medtronic | 2021 | — |
| −2 | K211958 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| −1 | K223181 | NuVasive Reline System | Nu Vasive, Incorporated | 2023 | — |
| 0 (this device) | K232650 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2023 | — |
| +1 | K251804 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2025 | — |
| +1 | K253990 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026 | — |
| +1 | K253721 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2025 | — |
| +1 | K260786 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026 | — |
| +1 | K262828 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 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 | 9 | 0 |
| 1997 | 10 | 0 |
| 1998 | 17 | 0 |
| 1999 | 14 | 0 |
| 2000 | 25 | 0 |
| 2001 | 31 | 0 |
| 2002 | 20 | 0 |
| 2003 | 23 | 0 |
| 2004 | 37 | 0 |
| 2005 | 27 | 0 |
| 2006 | 21 | 0 |
| 2007 | 18 | 0 |
| 2008 | 21 | 0 |
| 2009 | 12 | 0 |
| 2010 | 13 | 1 |
| 2011 | 12 | 0 |
| 2012 | 3 | 0 |
| 2013 | 10 | 0 |
| 2014 | 9 | 0 |
| 2015 | 7 | 0 |
| 2016 | 5 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 3 | 0 |
| 2026 | 3 | 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? (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 |
|---|---|---|---|
| * | K211981 | KHEIRON® Spinal Fixation SystemSummary page 4…8.3070 Classification Codes: Primary code: NKB Additional code: KWP Classification Panel: Orthopedic C1. PRIMARY PREDICATE DEVICE K211981 KHEIRON® Spinal Fixation System C2. ADDITIONAL PREDICATE DEVICE K223181… | 2022 |
| * | K223181 | NuVasive Reline SystemSummary page 4…anel: Orthopedic C1. PRIMARY PREDICATE DEVICE K211981 KHEIRON® Spinal Fixation System C2. ADDITIONAL PREDICATE DEVICE K223181 NuVasive Reline System… | 2023 |
What descends from it? (6)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251804 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | 2025 | 4 |
| K253990 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | 2026 | 2 |
| K253721 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | 2025 | 2 |
| K260786 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | 2026 | 1 |
| K262828 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | 2026 | 0 |
| K253093 | Vital™ Spinal Fixation System | 2025 | 0 |
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 · 7 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 6 companies; a new generation was cleared every 7 months on median.
- 46 of the 416 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K251804 (S.M.A.I.O, 2025) has gone furthest, with 4 descendants of its own.
- 6 other devices also cite its predicate K211981.
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?
The KHEIRON® Spinal Fixation System, including patient specific K-ROD, 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 thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic…
Read the full statement (222 words)
The KHEIRON® Spinal Fixation System, including patient specific K-ROD, 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 thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.
When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the KHEIRON® Spinal Fixation System including patient specific K-ROD is indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the KHEIRON® Spinal Fixation System including patient specific K-ROD is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion.
This system is intended to be used with autograft and/or allograft.
Pediatric pedicle screw fixation is limited to a posterior approach.
Patient specific K-ROD devices are compatible with NuVasive Reline System components that are compatible with ø5.5mm and/or ø6.0mm rods as well as screws ø4.5mm or larger and at least 25mm in length.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K232650 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232650: KHEIRON® Spinal Fixation System, including patient specific K-ROD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232650
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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