510(k) · Cleared
ClearedKHEIRON® Spinal Fixation System
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 Jun 9, 2022 as substantially equivalent to K201659 (S.M.A.I.O, 2020) and 1 other predicate after a 349-day review. Its family tree reaches back 10 generations to 2000. 8 later devices descend from it.
- Decided
- Jun 9, 2022
- Review
- 349 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K992147 (2000). 80 ancestors in all, the oldest K781443 (1978). 8 later devices descend from it, 7 citing it directly.
- Root · 10 generations backK992147 Triple-Fix Spinal Fixation SystemAdvanced Spine Technology, Inc. · 2000
- 6 generations between
- 3 generations backK110497 Pass LP Spinal SystemMedicrea International · 2011 · Recalled
- 2 generations backK123138 Pass LP Spinal SystemMedicrea International · 2013
- 1 generation backK140738 Pass LP Spinal SystemMedicrea International · 2014
- This deviceK211981 KHEIRON® Spinal Fixation SystemS.M.A.I.O · 2022
- Descendant · cites it directly · 6 of its ownK232650 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 ownK253802 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
Show all 10 generations
- Root · 10 generations backK992147 Triple-Fix Spinal Fixation SystemAdvanced Spine Technology, Inc. · 2000
- 9 generations backK001668 Global Spinal Fixation SystemD.K.M. Co., Ltd. · 2000
- 8 generations backK031455 Conklusion Pedicle Screw SystemSignus Medical, LLC · 2003
- 7 generations backK070933 Lowtop Pedicle Screw SystemSanacor · 2007
- 6 generations backK072187 Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology · 2007
- 5 generations backK080518 Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology · 2008
- 4 generations backK100297 Pass LP Spinal SystemMedicrea Technologies · 2010
- 3 generations backK110497 Pass LP Spinal SystemMedicrea International · 2011 · Recalled
- 2 generations backK123138 Pass LP Spinal SystemMedicrea International · 2013
- 1 generation backK140738 Pass LP Spinal SystemMedicrea International · 2014
- This deviceK211981 KHEIRON® Spinal Fixation SystemS.M.A.I.O · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · 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 · 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
- K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K992147 | Triple-Fix Spinal Fixation System | Advanced Spine Technology, Inc. | 2000 | — |
| −9 | K001668 | Global Spinal Fixation System | D.K.M. Co., Ltd. | 2000 | — |
| −8 | K031455 | Conklusion Pedicle Screw System | Signus Medical, LLC | 2003 | — |
| −7 | K070933 | Lowtop Pedicle Screw System | Sanacor | 2007 | — |
| −6 | K072187 | Pioneer Lowtop Spinal Rod System | Pioneer Surgical Technology | 2007 | — |
| −5 | K080518 | Pioneer Surgical Technology Quantum Spinal System | Pioneer Surgical Technology | 2008 | — |
| −4 | K100297 | Pass LP Spinal System | Medicrea Technologies | 2010 | — |
| −3 | K110497 | Pass LP Spinal System | Medicrea International | 2011 | 1 |
| −2 | K123138 | Pass LP Spinal System | Medicrea International | 2013 | — |
| −1 | K140738 | Pass LP Spinal System | Medicrea International | 2014 | — |
| 0 (this device) | K211981 | KHEIRON® Spinal Fixation System | S.M.A.I.O | 2022 | — |
| +1 | 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 | K253802 | 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 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 10 | 0 |
| 2001 | 7 | 0 |
| 2002 | 7 | 0 |
| 2003 | 5 | 0 |
| 2004 | 8 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 6 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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.
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 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 |
|---|---|---|---|
| * | K201659 | KHEIRON® Spinal Fixation SystemSummary page 4…icate Device Device: KHEIRON® Spinal Fixation System and more specifically its curved rods 24CR55XXX and 24CR60XXX. Company: S.M.A.I.O 510(k) number: K201659 K211981… | 2020 |
| * | K140738 | Pass LP Spinal SystemSummary page 5…Page 2 of 3 Additional Predicate Devices Device: PASS LP Spinal System Company: Medicrea international 510(k) number: K140738 7. Submitted Device Description K-RODs are titanium alloys bent rods, available in diameters 5.5mm and 6mm, which shape is… | 2014 |
What descends from it? (8)
7 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232650 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | 2023 | 6 |
| 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 |
| K253802 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | 2026 | 1 |
| K260786 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | 2026 | 1 |
| K262828 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | 2026 | 0 |
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?
- The line of descent spans 22 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 7 of the 80 ancestors have a recall of any class.
- 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 K201659.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 (183 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 implants are indicated as an adjunct to fusion to treat progresive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosos, 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.
The 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.
https://510kreport.com/device/K211981 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211981: 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/K211981
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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