510(k) · Cleared
ClearedAxis Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jun 16, 2008 as substantially equivalent to K953076 (Sofamor Danek USA,Inc., 1997) and 1 other predicate after a 682-day review. Its family tree reaches back 1 generation to 1997. 1 of the 225 devices in its family, counting itself, has a Class I recall. 222 later devices descend from it.
- Decided
- Jun 16, 2008
- Review
- 682 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K953076 (1997). 2 ancestors in all. 222 later devices descend from it, 2 citing it directly. 1 of the 225 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK953076 Townley Facet/Pedicular Screw Plating SystemSofamor Danek USA,Inc. · 1997
- This deviceK062254 Axis Fixation SystemMedtronic Sofamor Danek, Inc. · 2008
- Descendant · cites it directly · 192 of its ownK142838 Synapse Occipital-Cervical-Thoracic (OCT) SystemSynthes USA Products, LLC · 2015 · Recalled
- Descendant · cites it directly · 165 of its ownK143471 VERTEX Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2015
- Descendant · 2 generations on · 96 of its ownK150552 ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 78 of its ownK161591 QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation…Globus Medical, Inc. · 2016
- Descendant · 3 generations on · 69 of its ownK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
Showing 5 of 222 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 222 · See all- K142838Synapse Occipital-Cervical-Thoracic (OCT) SystemSynthes USA Products, LLC · 2015 · cites it directly192descendants
- K143471VERTEX Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2015 · cites it directly165descendants
- K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc. · 2015 · 2 generations on96descendants
- K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc. · 2016 · 2 generations on78descendants
- K171651Excelsius GPSGlobus Medical, Inc. · 2017 · 3 generations on69descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953076 | Townley Facet/Pedicular Screw Plating System | Sofamor Danek USA,Inc. | 1997 | — |
| 0 (this device) | K062254 | Axis Fixation System | Medtronic Sofamor Danek, Inc. | 2008 | — |
| +1 | K142838 | Synapse Occipital-Cervical-Thoracic (OCT) System | Synthes USA Products, LLC | 2015 | 1 |
| +1 | K143471 | VERTEX Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| +2 | K150552 | ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS | Globus Medical, Inc. | 2015 | 1 |
| +2 | K161591 | QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments | Globus Medical, Inc. | 2016 | — |
| +3 | K171651 | Excelsius GPS | Globus Medical, Inc. | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 17 | 0 |
| 2016 | 15 | 0 |
| 2017 | 17 | 0 |
| 2018 | 14 | 0 |
| 2019 | 14 | 0 |
| 2020 | 18 | 0 |
| 2021 | 11 | 1 |
| 2022 | 17 | 0 |
| 2023 | 26 | 0 |
| 2024 | 23 | 0 |
| 2025 | 23 | 0 |
| 2026 | 27 | 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 |
|---|---|---|---|
| * | K953076 | Townley Facet/Pedicular Screw Plating SystemSummary page 1…ther commercially available posterior cervical fixation systems and other pre-enactment devices including the TOWNLEY® Transfacetpedicular Fixation System (K953076, SE 2/19/97 and K021705, SE 07/24/02). Literature, mechanical test reports and clinical data were supplied in suppo… | 1997 |
| * | K021705 | Modification to Townley Transfacepedicular Screw Fixation SystemSummary page 1…ble posterior cervical fixation systems and other pre-enactment devices including the TOWNLEY® Transfacetpedicular Fixation System (K953076, SE 2/19/97 and K021705, SE 07/24/02). Literature, mechanical test reports and clinical data were supplied in support of establishing a claim of s… | 2002 |
What descends from it? (222)
See all 2222 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 AXIS® Fixation System may be used from the C2 to T3 (inclusive) spinal levels for the following indications: (1) trauma, including spinal fractures and/or dislocations; (2) cervical instability or deformity; (3) pseudarthrosis or failed previous fusions; and (4) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies; and/or degenerative disc disease of the facets with instability.…
Read the full statement (111 words)
The AXIS® Fixation System may be used from the C2 to T3 (inclusive) spinal levels for the following indications: (1) trauma, including spinal fractures and/or dislocations; (2) cervical instability or deformity; (3) pseudarthrosis or failed previous fusions; and (4) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies; and/or degenerative disc disease of the facets with instability. Spinal screw fixation is to be achieved with posterior pedicle and/or lateral mass screws and plates implanted from C2 to T3 levels inclusively. Supplemental posterior fixation with the ATLASTM Cable must be used. The AXIS® Fixation System must be used with autograft or allograft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062254 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062254: Axis Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062254
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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