510(k) Report

510(k) · Cleared

Cleared

KHEIRON® Spinal Fixation System

K201659510(k) TraditionalCleared Oct 5, 2020109-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 Oct 5, 2020 as substantially equivalent to K020247 (Medtronic Sofamor Danek, Inc., 2002) after a 109-day review. Its family tree reaches back 1 generation to 2002. 10 later devices descend from it.

Decided
Oct 5, 2020
Review
109 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K020247 (2002). 10 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2021: 1 descendant cleared2022: 1 descendant cleared2026: 4 descendants cleared2025: 3 descendants cleared2023: 1 descendant clearedReference device: K143633 · CREO Stabilization System · Globus Medical, Inc. · 2015Reference device: K124058 · Creo Stabilization System · Globus Medical, Inc. · 2013Reference device: K113395 · Revere 4.5 Stabilization System · Globus Medical, Inc. · 2012Reference device: K940631 · Cross Medical - Synergy (TM) Spine System · Cross Medical Products, Inc. · 1995Reference device: K950099 · Synergy (TM) TI Posterior Spinal System · Buckman Co., Inc. · 1997Reference device: K920116 · PWB Lumbosacral Spine System · Cross Medical Products, Inc. · 1992Reference device: K000536 · Synthes Anterior CSLP System · Synthes Spine · 2000 · recalledReference device: K955348 · Titanium Moss Miami Spinal System · Depuy, Inc. · 1996Reference device: K954696 · Rogozinski Thoracolumbar Spinal Rod · Smith & Nephew Richards, Inc. · 1996K020247 · Colorado 2 Spinal System · Medtronic Sofamor Danek, Inc. · 2002200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 6 descendants3 generations forward: 1 descendant K020247 · Colorado 2 Spinal System · Medtronic Sofamor Danek, Inc. · 20020
  1. Root · 1 generation backK020247 Colorado 2 Spinal SystemMedtronic Sofamor Danek, Inc. · 2002
  2. This deviceK201659 KHEIRON® Spinal Fixation SystemS.M.A.I.O · 2020
  3. Descendant · cites it directly · 8 of its ownK211981 KHEIRON® Spinal Fixation SystemS.M.A.I.O · 2022
  4. Descendant · 2 generations on · 6 of its ownK232650 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2023
  5. Descendant · 2 generations on · 4 of its ownK251804 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2025
  6. Descendant · 2 generations on · 2 of its ownK253990 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
  7. Descendant · 2 generations on · 2 of its ownK253721 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2025

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2021: 12022: 12023: 12025: 32026: 4
2021high 4 (2026) · low 0 (2024)2026

Most influential descendants

Showing 5 of 10 · See all
  • K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O · 2022 · cites it directly8descendants
  • K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2023 · 2 generations on6descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K020247Colorado 2 Spinal SystemMedtronic Sofamor Danek, Inc.2002—
0 (this device)K201659KHEIRON® Spinal Fixation SystemS.M.A.I.O2020—
+1K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O2022—
+2K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2023—
+2K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2025—
+2K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2026—
+2K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
202210
202310
202530
202640
FIG. 1 — Lineage of K201659, 2002–2026Source: 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.

Planning a device in NKB? 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? (1)

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
*K020247Colorado 2 Spinal System
Summary page 4
…21 CFR section 888.3070 Device Panel Orthopedic Primary Predicate COLORADO 2™ Spinal System, Medtronic Sofarnor Danek (K020247) Device Revere® / CREO™ Stabilization System, Globus Medical (K143633 / K124058 / K113395)…
Medtronic Sofamor Danek, Inc.2002—
†K143633CREO Stabilization SystemGlobus Medical, Inc.2015—
†K124058Creo Stabilization SystemGlobus Medical, Inc.2013—
†K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012—
†K940631Cross Medical - Synergy (TM) Spine SystemCross Medical Products, Inc.1995—
†K950099Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc.1997—
†K920116PWB Lumbosacral Spine SystemCross Medical Products, Inc.1992—
†K000536Synthes Anterior CSLP SystemSynthes Spine20001
†K955348Titanium Moss Miami Spinal SystemDepuy, Inc.1996—
†K954696Rogozinski Thoracolumbar Spinal RodSmith & Nephew Richards, Inc.1996—

Also cleared against K020247: 1 other device →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O20228
K211414KHEIRON Spinal Fixation SystemS.M.A.I.O20212
K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K211981 (S.M.A.I.O, 2022) has gone furthest, with 8 descendants of its own.
  • 1 other device also cites its predicate K020247.

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. 2020, 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?

The KHEIRON Spinal Fixation 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 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…

Read the full statement (180 words)

The KHEIRON Spinal Fixation 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 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 implants are 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 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.

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 K020247

1 other device cites the same predicate.

  • K211414KHEIRON Spinal Fixation SystemS.M.A.I.O · 2021

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/K201659 · printed Nov 6, 2026

Cite this page

510(k) Report. “K201659: KHEIRON® Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201659

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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