510(k) Report

510(k) · Cleared

Cleared

KHEIRON® Spinal Fixation System, including patient specific K-ROD

K262828510(k) SpecialCleared Sep 4, 202625-day reviewClass II21 CFR 888.3070

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

S.M.A.I.O · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Sep 4, 2026 as substantially equivalent to K211981 (S.M.A.I.O, 2022) and 12 other predicates after a 25-day review. Its family tree reaches back 34 generations to 1984. 2 of the 1,042 devices in its family, counting itself, have a Class I recall.

Decided
Sep 4, 2026
Review
25 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
13

Its longest line of descent runs back 34 generations to K841189 (1984). 1,041 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 2 of the 1,042 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year cleared 2026: 2 other ancestors2025: 3 other ancestors2024: 1 other ancestor2023: 4 other ancestors2022: 5 other ancestors2020: 11 other ancestors2018: 12 other ancestors2021: 9 other ancestors2016: 33 other ancestors2014: 51 other ancestors2013: 46 other ancestors2012: 41 other ancestors2009: 60 other ancestors2019: 10 other ancestors2015: 46 other ancestors2010: 48 other ancestors, 1 with a Class I recall12008: 74 other ancestors, 1 with a Class I recall12007: 41 other ancestors2006: 45 other ancestors2005: 59 other ancestors2004: 64 other ancestors2003: 43 other ancestors2002: 34 other ancestors2001: 36 other ancestors2017: 29 other ancestors2011: 61 other ancestors2000: 28 other ancestors1999: 17 other ancestors1998: 21 other ancestors1996: 11 other ancestors1997: 11 other ancestors1995: 17 other ancestors1994: 7 other ancestors1992: 8 other ancestors1978: 1 other ancestor1993: 4 other ancestors1990: 3 other ancestors1988: 2 other ancestors1987: 1 other ancestor1989: 1 other ancestor1986: 2 other ancestors1985: 2 other ancestors1984: 1 other ancestor1980: 1 other ancestor1979: 1 other ancestorK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) ×2: 2 generations cleared close together, K041888 (2004), K042930 (2004) K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007×2: 2 generations cleared close together, K072120 (2007), K073291 (2008) K094025 · Crescent Spinal System · Medtronic Sofamor Danek · 2010K110543 · Crescent (R) Spinal System Titanium · Medtronic Sofamor Danek USA, Inc. · 2011×2: 2 generations cleared close together, K121683 (2012), K123752 (2013) K132505 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013 · recalled×3: 3 generations cleared close together, K141217 (2014), K143163 (2015), K143616 (2015) K152304 · Tritanium PL Cage · Stryker · 2015 · recalled×2: 2 generations cleared close together, K160955 (2016), K162262 (2016) K171496 · Tritanium C Anterior Cervical Cage · Stryker Spine · 2017K180364 · HD LifeSciences Cervical IBFD System · Hd Lifesciences, LLC · 2018×3: 3 generations cleared close together, K183557 (2019), K192018 (2019), K191581 (2020) K201267 · Adaptix Interbody System with Titan nanoLOCK Surface Technology · Medtronic Sofamor Danek · 2020×3: 3 generations cleared close together, K210425 (2021), K212524 (2021), K214010 (2022) K223494 · CD Horizon Spinal System · Medtronic · 2023K233951 · CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) · Medtronic Sofamor Danek USA, Inc. · 2024K243007 · CD Horizon™ Spinal System · Medtronic Sofamor Danek USA, Inc. · 2024K253802 · KHEIRON® Spinal Fixation System, including patient specific K-ROD · S.M.A.I.O · 202619801990200020102020
Other ancestors, by generation 1 generation back: 12 other ancestors2 generations back: 18 other ancestors3 generations back: 39 other ancestors4 generations back: 93 other ancestors5 generations back: 133 other ancestors6 generations back: 94 other ancestors7 generations back: 93 other ancestors8 generations back: 90 other ancestors, 1 with a Class I recall19 generations back: 123 other ancestors10 generations back: 137 other ancestors, 1 with a Class I recall111 generations back: 98 other ancestors12 generations back: 45 other ancestors13 generations back: 17 other ancestors14 generations back: 9 other ancestors15 generations back: 5 other ancestors16 generations back: 1 other ancestor K253802 · KHEIRON® Spinal Fixation System, including patient specific K-ROD · S.M.A.I.O · 2026K243007 · CD Horizon™ Spinal System · Medtronic Sofamor Danek USA, Inc. · 2024K233951 · CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) · Medtronic Sofamor Danek USA, Inc. · 2024K223494 · CD Horizon Spinal System · Medtronic · 2023K214010 · Anteralign Spinal System with Titan nanoLOCK Surface Technology · Medtronic Sofamor Danek USA · 2022K212524 · Anteralign Spinal System with Titan nanoLOCK Surface Technology · Medtronic Sofamor Danek USA, Inc. · 2021K210425 · Catalyft PL Expandable Interbody System · Medtronic Sofamor Danek USA, Inc. · 2021 · recalledK201267 · Adaptix Interbody System with Titan nanoLOCK Surface Technology · Medtronic Sofamor Danek · 2020K191581 · Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device · Titan Spine, Inc. · 2020K192018 · Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device · Titan Spine, Inc. · 2019 · recalledK183557 · Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device · Titan Spine, Inc. · 2019 · recalledK180364 · HD LifeSciences Cervical IBFD System · Hd Lifesciences, LLC · 2018K171496 · Tritanium C Anterior Cervical Cage · Stryker Spine · 2017K162262 · Tritanium® PL Cage · Stryker · 2016K160955 · Tritanium® PL Cage · Stryker · 2016K152304 · Tritanium PL Cage · Stryker · 2015 · recalledK143616 · AccuLIF TL and PL Cage · Stryker Corporation · 2015 · recalledK143163 · AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System · Stryker Corporation · 2015K141217 · Acculif TL and PL Cage · Stryker Corporation · 2014 · recalledK132505 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013 · recalledK123752 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013K121683 · Acculif TL Cage · Coalign Innovations, Inc. · 2012K110543 · Crescent (R) Spinal System Titanium · Medtronic Sofamor Danek USA, Inc. · 2011K094025 · Crescent Spinal System · Medtronic Sofamor Danek · 2010K073291 · Capstone Spinal System · Medtronic Sofamor Danek USA, Inc. · 2008K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K042930 · Spacevision Cage System · Spine Vision, Inc. · 2004K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−30−25−20−15−10−50
  1. Root · 34 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 30 generations between
  3. 3 generations backK233951 CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set…Medtronic Sofamor Danek USA, Inc. · 2024
  4. 2 generations backK243007 CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2024
  5. 1 generation backK253802 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
  6. This deviceK262828 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
Show all 34 generations
  1. Root · 34 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 33 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 32 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 31 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 30 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 29 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 28 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 27 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 26 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 25 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
  11. 24 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
  12. 23 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
  13. 22 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
  14. 21 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
  15. 20 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
  16. 19 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
  17. 18 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
  18. 17 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
  19. 16 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
  20. 15 generations backK160955 Tritanium® PL CageStryker · 2016
  21. 14 generations backK162262 Tritanium® PL CageStryker · 2016
  22. 13 generations backK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
  23. 12 generations backK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
  24. 11 generations backK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
  25. 10 generations backK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
  26. 9 generations backK191581 Endoskeleton TL Interbody Fusion Device, Endoskeleton TL…Titan Spine, Inc. · 2020
  27. 8 generations backK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
  28. 7 generations backK210425 Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2021 · Recalled
  29. 6 generations backK212524 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021
  30. 5 generations backK214010 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
  31. 4 generations backK223494 CD Horizon Spinal SystemMedtronic · 2023
  32. 3 generations backK233951 CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set…Medtronic Sofamor Danek USA, Inc. · 2024
  33. 2 generations backK243007 CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2024
  34. 1 generation backK253802 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
  35. This deviceK262828 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026

Class I recalls in this family

  • K100952 Modification to Synthes Matrix System8 generations back · 2010
  • K073202 Ardis Spacer10 generations back · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−34K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−33K990148Stackable Cage SystemDepuy Motech Acromed1999—
−32K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−31K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−30K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−29K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−28K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−27K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−26K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−25K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008—
−24K094025Crescent Spinal SystemMedtronic Sofamor Danek2010—
−23K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011—
−22K121683Acculif TL CageCoalign Innovations, Inc.2012—
−21K123752Acculif TL and PL CageCoalign Innovations, Inc.2013—
−20K132505Acculif TL and PL CageCoalign Innovations, Inc.20133
−19K141217Acculif TL and PL CageStryker Corporation20143
−18K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK…Stryker Corporation2015—
−17K143616AccuLIF TL and PL CageStryker Corporation20154
−16K152304Tritanium PL CageStryker20151
−15K160955Tritanium® PL CageStryker2016—
−14K162262Tritanium® PL CageStryker2016—
−13K171496Tritanium C Anterior Cervical CageStryker Spine2017—
−12K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018—
−11K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion…Titan Spine, Inc.20193
−10K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc.20194
−9K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic…Titan Spine, Inc.2020—
−8K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek2020—
−7K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20211
−6K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.2021—
−5K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA2022—
−4K223494CD Horizon Spinal SystemMedtronic2023—
−3K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.2024—
−2K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.2024—
−1K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2026—
0 (this device)K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
197910
198010
198410
198520
198620
198710
198820
198910
199030
199280
199340
199470
1995170
1996110
1997110
1998210
1999170
2000280
2001360
2002340
2003430
2004640
2005590
2006450
2007410
2008741
2009600
2010481
2011610
2012410
2013460
2014510
2015460
2016330
2017290
2018120
2019100
2020110
202190
202250
202340
202410
202530
202620
FIG. 1 — Lineage of K262828, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

2 devices in this family have 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. #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 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? (13)

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
*K211981KHEIRON® Spinal Fixation System
Summary page 5
….3070 Product Code(s) NKB, KWP I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K211981 KHEIRON® Spinal Fixation System, including patient specific K- | | NKB ROD K253802 KHEIRON® Spinal Fixation System, including pat…
S.M.A.I.O2022—
*K253802KHEIRON® Spinal Fixation System, including patient specific K-ROD
Summary page 5
…)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K211981 KHEIRON® Spinal Fixation System, including patient specific K- | | NKB ROD K253802 KHEIRON® Spinal Fixation System, including patient specific K- | | NKB ROD K171421 VERTICALE® Posterior Spinal Fixation System/VE…
S.M.A.I.O2026—
*K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® System
Summary page 5
…ode K211981 KHEIRON® Spinal Fixation System, including patient specific K- | | NKB ROD K253802 KHEIRON® Spinal Fixation System, including patient specific K- | | NKB ROD K171421 VERTICALE® Posterior Spinal Fixation System/VERTICALE® NKB System K222110 Mariner RDX System NKB K251804 KHEIRON® Spinal Fixation…
Silony Medical GmbH2018—
*K222110Mariner RDX System
Summary page 5
…| | NKB ROD K253802 KHEIRON® Spinal Fixation System, including patient specific K- | | NKB ROD K171421 VERTICALE® Posterior Spinal Fixation System/VERTICALE® NKB System K222110 Mariner RDX System NKB K251804 KHEIRON® Spinal Fixation System, including patient specific K- | | NKB ROD K262828…
SeaSpine Orthopedics Corporation20222
*K251804KHEIRON® Spinal Fixation System, including patient specific K-ROD
Summary page 5
…pinal Fixation System, including patient specific K- | | NKB ROD K171421 VERTICALE® Posterior Spinal Fixation System/VERTICALE® NKB System K222110 Mariner RDX System NKB K251804 KHEIRON® Spinal Fixation System, including patient specific K- | | NKB ROD K262828- Page 2 of 4 K240539 Vital™ S…
S.M.A.I.O2025—
*K240539Vital™ Spinal Fixation System
Summary page 6
…ICALE® NKB System K222110 Mariner RDX System NKB K251804 KHEIRON® Spinal Fixation System, including patient specific K- | | NKB ROD K262828- Page 2 of 4 K240539 Vital™ Spinal Fixation System NKB K253721 KHEIRON® Spinal Fixation System, including patient specific K- | | NKB ROD K200245 EX…
Zimvie Spine (Zimmer Biomet Spine, Inc.)2024—
*K253721KHEIRON® Spinal Fixation System, including patient specific K-ROD
Summary page 6
…m NKB K251804 KHEIRON® Spinal Fixation System, including patient specific K- | | NKB ROD K262828- Page 2 of 4 K240539 Vital™ Spinal Fixation System NKB K253721 KHEIRON® Spinal Fixation System, including patient specific K- | | NKB ROD K200245 EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine…
S.M.A.I.O2025—
*K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System
Summary page 6
…ROD K262828- Page 2 of 4 K240539 Vital™ Spinal Fixation System NKB K253721 KHEIRON® Spinal Fixation System, including patient specific K- | | NKB ROD K200245 EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine NKB System K231479 TriALTIS Spine System NKB K253990 KHEIRON® Spinal Fixation Sys…
Medos International Sàrl2020—
*K231479TriALTIS Spine System
Summary page 6
…ixation System NKB K253721 KHEIRON® Spinal Fixation System, including patient specific K- | | NKB ROD K200245 EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine NKB System K231479 TriALTIS Spine System NKB K253990 KHEIRON® Spinal Fixation System, including patient specific K- | | NKB ROD K250908 Virata Spi…
Medos International SARL2023—
*K253990KHEIRON® Spinal Fixation System, including patient specific K-ROD
Summary page 6
…® Spinal Fixation System, including patient specific K- | | NKB ROD K200245 EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine NKB System K231479 TriALTIS Spine System NKB K253990 KHEIRON® Spinal Fixation System, including patient specific K- | | NKB ROD K250908 Virata Spinal Fixation System NKB K260786 KH…
S.M.A.I.O2026—
*K250908Virata Spinal Fixation System
Summary page 6
…M® Spine System; EXPEDIUM VERSE® Spine NKB System K231479 TriALTIS Spine System NKB K253990 KHEIRON® Spinal Fixation System, including patient specific K- | | NKB ROD K250908 Virata Spinal Fixation System NKB K260786 KHEIRON® Spinal Fixation System, including patient specific K- | | NKB ROD K232650 KH…
SeaSpine Orthopedics Corporation20251
*K260786KHEIRON® Spinal Fixation System, including patient specific K-ROD
Summary page 6
…System K231479 TriALTIS Spine System NKB K253990 KHEIRON® Spinal Fixation System, including patient specific K- | | NKB ROD K250908 Virata Spinal Fixation System NKB K260786 KHEIRON® Spinal Fixation System, including patient specific K- | | NKB ROD K232650 KHEIRON® Spinal Fixation System, including pa…
S.M.A.I.O2026—
*K232650KHEIRON® Spinal Fixation System, including patient specific K-ROD
Summary page 6
…including patient specific K- | | NKB ROD K250908 Virata Spinal Fixation System NKB K260786 KHEIRON® Spinal Fixation System, including patient specific K- | | NKB ROD K232650 KHEIRON® Spinal Fixation System, including patient specific K- | | NKB ROD Device Description Summary 21 CFR 807.92(a)(4) S.M.A…
S.M.A.I.O2023—

Also cleared against K211981: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (2 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 · 8 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
  • K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 10 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 42 years and passes through 18 companies; a new generation was cleared every 9 months on median.
  • 121 of the 1,041 ancestors have a recall of any class; 2 have a Class I recall.
  • 6 other devices also cite its predicate K211981.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007: 382008: 362009: 442010: 372011: 482012: 602013: 352014: 462015: 552016: 502017: 632018: 562019: 392020: 482021: 322022: 342023: 442024: 392025: 242026 (partial year): 30
2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007: 87 days median2008: 59 days median2009: 71 days median2010: 111 days median2011: 84 days median2012: 79 days median2013: 73 days median2014: 90 days median2015: 90 days median2016: 84 days median2017: 69 days median2018: 61 days median2019: 84 days median2020: 68 days median2021: 61 days median2022: 88 days median2023: 72 days median2024: 57 days median2025: 61 days median2026 (partial year): 91 days median
2007high 111 (2010) · low 57 (2024)2026

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

Recalls per year · NKB

1in 2025

2007: 42008: 52009: 332010: 42011: 32012: 132014: 3, 1 Class I2015: 32016: 12017: 12018: 32019: 12020: 12022: 52023: 22024: 32025: 12026 (partial year): 3
2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007: 342008: 822009: 1712010: 4622011: 5772012: 1,7472013: 1,9622014: 1,6712015: 1,4462016: 1,5852017: 1,6182018: 1,6842019: 1,9152020: 2,0762021: 1,7452022: 1,3392023: 9192024: 1,6142025: 1,171
2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, 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
20073887434
20083659582
2009447133171
2010371114462
201148843577
20126079131,747
2013357301,962
201446903 (1)1,671
2015559031,446
2016508411,585
2017636911,618
2018566131,684
2019398411,915
2020486812,076
2021326101,745
2022348851,339
202344722919
2024395731,614
2025246111,171
202630913—

What is it indicated for?

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 (302 words)

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, 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, nheuromuscular

scoliosis, and congenital scoliosis. Additionally, 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.

When connected to compatible pedicle screw systems, the 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.

Please refer to the additional information section of the most up-to-date Instructions for Use on compatible

pedicle screw systems.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K211981

6 other devices cite the same predicate.

  • K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
  • K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
  • K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
  • K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2025
  • K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2025
  • K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2023

More from S.M.A.I.O

13 FDA decisions under this applicant name. See the company

  • K261500KBA3D (v2.4.0)S.M.A.I.O · 2026
  • K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
  • K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
  • K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
  • K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2025

Recent decisions in NKB

The NKB category page

  • K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. · 2026
  • K263062NOVIX Pedicle Screw SystemTdm Co., Ltd. · 2026
  • K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
  • K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc. · 2026
  • K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026

https://510kreport.com/device/K262828 · printed Nov 5, 2026

Cite this page

510(k) Report. “K262828: 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 5, 2026. https://510kreport.com/device/K262828

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Record history
  • FDA decision record loaded Oct 30, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026