510(k) Report

510(k) · Cleared

Cleared

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

K251804510(k) SpecialCleared Jul 8, 202526-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 Jul 8, 2025 as substantially equivalent to K211981 (S.M.A.I.O, 2022) and 2 other predicates after a 26-day review. Its family tree reaches back 25 generations to 2004. 1 of the 461 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.

Decided
Jul 8, 2025
Review
26 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
3

Its longest line of descent runs back 25 generations to K040583 (2004). 456 ancestors in all, the oldest K781443 (1978). 4 later devices descend from it, 4 citing it directly. 1 of the 461 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2022: 2 other ancestors2021: 3 other ancestors2020: 3 other ancestors2016: 7 other ancestors2014: 9 other ancestors2012: 4 other ancestors2019: 3 other ancestors2018: 5 other ancestors2013: 10 other ancestors2009: 13 other ancestors2007: 19 other ancestors2006: 22 other ancestors2005: 30 other ancestors2004: 38 other ancestors2002: 22 other ancestors2017: 4 other ancestors2011: 12 other ancestors2008: 21 other ancestors2003: 25 other ancestors2001: 31 other ancestors2000: 27 other ancestors1999: 14 other ancestors2010: 13 other ancestors, 1 with a Class I recall11998: 19 other ancestors1997: 11 other ancestors1996: 9 other ancestors1994: 7 other ancestors2015: 8 other ancestors1995: 15 other ancestors1993: 4 other ancestors1992: 7 other ancestors1990: 3 other ancestors1984: 2 other ancestors1988: 2 other ancestors1987: 1 other ancestor1978: 1 other ancestor1989: 1 other ancestor1986: 2 other ancestors1985: 2 other ancestors2026: 3 descendants cleared2025: 1 descendant cleared×7: 7 generations cleared close together, K040583 (2004), K041118 (2004), K042025 (2004), K043151 (2005), K050809 (2005), K052187 (2005), K053101 (2006) ×2: 2 generations cleared close together, K091442 (2009), K091974 (2009) K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010×2: 2 generations cleared close together, K112473 (2011), K113174 (2011) ×2: 2 generations cleared close together, K121680 (2012), K122862 (2012) K141605 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2014K143019 · CD HORIZON Spinal System, IPC POWEREASE System · Medtronic Sofamor Danek USA, Inc. · 2015K153463 · CD HORIZON Spinal System, IPC POWEREASE System · Medtronic Sofamor Danek USA, Inc. · 2015K170679 · CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems · Medtronic Sofamor Danek · 2017×2: 2 generations cleared close together, K191148 (2019), K193011 (2020) K201362 · CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement · Medtronic · 2020×2: 2 generations cleared close together, K210637 (2021), K211958 (2021) K223181 · NuVasive Reline System · Nu Vasive, Incorporated · 2023K232650 · KHEIRON® Spinal Fixation System, including patient specific K-ROD · S.M.A.I.O · 202319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 5 other ancestors3 generations back: 15 other ancestors4 generations back: 21 other ancestors5 generations back: 53 other ancestors6 generations back: 63 other ancestors7 generations back: 71 other ancestors8 generations back: 59 other ancestors, 1 with a Class I recall19 generations back: 36 other ancestors10 generations back: 46 other ancestors11 generations back: 18 other ancestors12 generations back: 15 other ancestors13 generations back: 13 other ancestors14 generations back: 8 other ancestors15 generations back: 4 other ancestors16 generations back: 2 other ancestors 1 generation forward: 4 descendants K232650 · KHEIRON® Spinal Fixation System, including patient specific K-ROD · S.M.A.I.O · 2023K223181 · NuVasive Reline System · Nu Vasive, Incorporated · 2023K211958 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2021K210637 · CD Horizon™ Spinal System · Medtronic · 2021K201362 · CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement · Medtronic · 2020K193011 · CD Horizon™ Fenestrated Screw Set · Medtronic Sofamor Danek USA, Inc. · 2020K191148 · Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set · Medtronic Sofamor Danek USA, Inc. · 2019K170679 · CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems · Medtronic Sofamor Danek · 2017K153463 · CD HORIZON Spinal System, IPC POWEREASE System · Medtronic Sofamor Danek USA, Inc. · 2015K143019 · CD HORIZON Spinal System, IPC POWEREASE System · Medtronic Sofamor Danek USA, Inc. · 2015K141605 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2014K122862 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012K121680 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012K113174 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2011 · recalledK112473 · CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2011K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010K091974 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2009 · recalledK091442 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2009K053101 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2006K052187 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K050809 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2005K043151 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K042025 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2004 · recalledK041118 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek · 2004K040583 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2004−25−20−15−10−50
  1. Root · 25 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 21 generations between
  3. 3 generations backK211958 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2021
  4. 2 generations backK223181 NuVasive Reline SystemNu Vasive, Incorporated · 2023
  5. 1 generation backK232650 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2023
  6. This deviceK251804 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2025
  7. Descendant · cites it directly · 2 of its ownK253990 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
  8. Descendant · cites it directly · 2 of its ownK253721 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2025
  9. Descendant · cites it directly · 1 of its ownK260786 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
  10. Descendant · cites it directly · 0 of its ownK262828 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
Show all 25 generations
  1. Root · 25 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 24 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 23 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 22 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 21 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 20 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 19 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 18 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 17 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 16 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 15 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 14 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 13 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 12 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  15. 11 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
  16. 10 generations backK143019 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
  17. 9 generations backK153463 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
  18. 8 generations backK170679 CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use…Medtronic Sofamor Danek · 2017
  19. 7 generations backK191148 Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™…Medtronic Sofamor Danek USA, Inc. · 2019
  20. 6 generations backK193011 CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc. · 2020
  21. 5 generations backK201362 CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System…Medtronic · 2020
  22. 4 generations backK210637 CD Horizon™ Spinal SystemMedtronic · 2021
  23. 3 generations backK211958 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2021
  24. 2 generations backK223181 NuVasive Reline SystemNu Vasive, Incorporated · 2023
  25. 1 generation backK232650 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2023
  26. This deviceK251804 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2025

Class I recalls in this family

  • K100952 Modification to Synthes Matrix System8 generations back · 2010

Most influential descendants

Showing 4 of 4 · See all
  • 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

GenerationNumberDeviceApplicantDecidedRecalls
−25K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−24K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−23K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−22K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−21K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−20K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−19K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−18K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−17K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−16K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−15K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−14K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−13K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−12K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−11K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014—
−10K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.2015—
−9K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.2015—
−8K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the…Medtronic Sofamor Danek2017—
−7K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™…Medtronic Sofamor Danek USA, Inc.2019—
−6K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.2020—
−5K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™…Medtronic2020—
−4K210637CD Horizon™ Spinal SystemMedtronic2021—
−3K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2021—
−2K223181NuVasive Reline SystemNu Vasive, Incorporated2023—
−1K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2023—
0 (this device)K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2025—
+1K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2026—
+1K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2025—
+1K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2026—
+1K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198420
198520
198620
198710
198820
198910
199030
199270
199340
199470
1995150
199690
1997110
1998190
1999140
2000270
2001310
2002220
2003250
2004380
2005300
2006220
2007190
2008210
2009130
2010131
2011120
201240
2013100
201490
201580
201670
201740
201850
201930
202030
202130
202220

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202510
202630
FIG. 1 — Lineage of K251804, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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.

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. #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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K211981KHEIRON® Spinal Fixation System
Summary page 5
…3050 Classification Codes: Primary code: NKB Additional code: KWP Classification Panel: Orthopedic C1. PRIMARY PREDICATE DEVICE K211981, K232650 KHEIRON® Spinal Fixation System C2. ADDITIONAL PREDICATE DEVICE K222110…
S.M.A.I.O2022—
*K232650KHEIRON® Spinal Fixation System, including patient specific K-ROD
Summary page 5
…ssification Codes: Primary code: NKB Additional code: KWP Classification Panel: Orthopedic C1. PRIMARY PREDICATE DEVICE K211981, K232650 KHEIRON® Spinal Fixation System C2. ADDITIONAL PREDICATE DEVICE K222110 Seaspine…
S.M.A.I.O2023—
*K222110Mariner RDX System
Summary page 5
…: Orthopedic C1. PRIMARY PREDICATE DEVICE K211981, K232650 KHEIRON® Spinal Fixation System C2. ADDITIONAL PREDICATE DEVICE K222110 Seaspine Mariner System…
SeaSpine Orthopedics Corporation20222

Also cleared against K211981: 6 other devices →

What descends from it? (4)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262
K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252
K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261
K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260

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 · 8 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 7 months on median.
  • 54 of the 456 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K253990 (S.M.A.I.O, 2026) has gone furthest, with 2 descendants of its own.
  • 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. 2025, 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 (224 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, neuromuscular 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.

Patient specific K-ROD devices are compatible with NuVasive Reline System components and Seaspine Mariner 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 as stated in the FDA summary.

Also cleared against K211981

6 other devices cite the same predicate.

  • K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.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
  • 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

  • K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
  • 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

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/K251804 · printed Nov 5, 2026

Cite this page

510(k) Report. “K251804: 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/K251804

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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