510(k) · Cleared
Recalled · Class II · 2019Synapse Occipital-Cervical-Thoracic (OCT) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes USA Products, LLC · NKG Posterior Cervical Screw System
Cleared on Jan 20, 2015 as substantially equivalent to K062254 (Medtronic Sofamor Danek, Inc., 2008) after a 112-day review. Its family tree reaches back 2 generations to 1997. 1 of the 196 devices in its family, counting itself, has a Class I recall. 192 later devices descend from it. It has been recalled once.
- Decided
- Jan 20, 2015
- Review
- 112 days
- Class
- Class II
- Product code
- NKG
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K953076 (1997). 3 ancestors in all. 192 later devices descend from it, 32 citing it directly. 1 of the 196 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK953076 Townley Facet/Pedicular Screw Plating SystemSofamor Danek USA,Inc. · 1997
- 1 generation backK062254 Axis Fixation SystemMedtronic Sofamor Danek, Inc. · 2008
- This deviceK142838 Synapse Occipital-Cervical-Thoracic (OCT) SystemSynthes USA Products, LLC · 2015
- Descendant · cites it directly · 96 of its ownK150552 ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc. · 2015 · Recalled
- Descendant · cites it directly · 78 of its ownK161591 QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation…Globus Medical, Inc. · 2016
- Descendant · 2 generations on · 69 of its ownK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
- Descendant · 3 generations on · 42 of its ownK191100 ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019
- Descendant · cites it directly · 41 of its ownK151885 SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal SystemDepuy Synthes, Inc. · 2015
Showing 5 of 192 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub3 generations on · 2021
Most influential descendants
Showing 5 of 192 · See all- K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc. · 2015 · cites it directly96descendants
- K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc. · 2016 · cites it directly78descendants
- K171651Excelsius GPSGlobus Medical, Inc. · 2017 · 2 generations on69descendants
- K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019 · 3 generations on42descendants
- K151885SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal SystemDepuy Synthes, Inc. · 2015 · cites it directly41descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953076 | Townley Facet/Pedicular Screw Plating System | Sofamor Danek USA,Inc. | 1997 | — |
| −1 | K062254 | Axis Fixation System | Medtronic Sofamor Danek, Inc. | 2008 | — |
| 0 (this device) | K142838 | Synapse Occipital-Cervical-Thoracic (OCT) System | Synthes USA Products, LLC | 2015 | — |
| +1 | K150552 | ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS | Globus Medical, Inc. | 2015 | 1 |
| +1 | K161591 | QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments | Globus Medical, Inc. | 2016 | — |
| +2 | K171651 | Excelsius GPS | Globus Medical, Inc. | 2017 | 1 |
| +3 | K191100 | ExcelsiusGPS Spine 1.1 Interbody Module | Globus Medical, Inc. | 2019 | — |
| +1 | K151885 | SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System | Depuy Synthes, Inc. | 2015 | — |
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 | 10 | 0 |
| 2016 | 9 | 0 |
| 2017 | 14 | 0 |
| 2018 | 12 | 0 |
| 2019 | 12 | 0 |
| 2020 | 17 | 0 |
| 2021 | 10 | 1 |
| 2022 | 15 | 0 |
| 2023 | 24 | 0 |
| 2024 | 23 | 0 |
| 2025 | 20 | 0 |
| 2026 | 26 | 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 NKG device
- #1 K252327 CMORE® CT System; CMORE® CT System Navigated…score 19.6 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K062254 | Axis Fixation SystemSummary page 4…Orthopaedic and Rehabilitation Devices Panel Class 2 per 21 CFR 888.3050 Product Code: KWP Predicate Device: K062254- Medtronic Sofamor Danek’s AXIS® Fixation System Device Description: The Synapse OCT System, including Synapse, OC Fusion and… | 2008 |
What descends from it? (192)
See all 19232 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150552 | ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS | 2015 | 96 |
| K161591 | QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments | 2016 | 78 |
| K151885 | SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System | 2015 | 41 |
| K150539 | OASYS System | 2015 | 34 |
| K150474 | NuVasive VuePoint II OCT System | 2015 | 26 |
| K151224 | Lineum OCT Spine System | 2015 | 23 |
| K150822 | Centurion POCT System | 2015 | 23 |
| K171444 | YUKON OCT Spinal System | 2017 | 13 |
| K162639 | Proficient™ Posterior Cervical Spine System | 2017 | 13 |
| K172594 | Proficient® Posterior Cervical Spine System | 2017 | 12 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 16, 2019 | Class II | Z-0223-2020 | Process control | The subject product measures 4.0mm in diameter instead of 3.5mm. |
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 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 11.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K150552 (Globus Medical, Inc., 2015) has gone furthest, with 96 descendants of its own.
- 1 other device also cites its predicate K062254.
How does its category compare?
All NKG devicesNKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · NKG
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKG
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKG
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NKG
153in 2025
MAUDE reports naming product code NKG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 17 | 71 | 0 | 4 |
| 2016 | 16 | 87 | 0 | 73 |
| 2017 | 15 | 108 | 0 | 99 |
| 2018 | 12 | 61 | 1 | 127 |
| 2019 | 8 | 50 | 1 | 214 |
| 2020 | 14 | 59 | 2 | 236 |
| 2021 | 7 | 56 | 0 | 704 |
| 2022 | 7 | 108 | 0 | 175 |
| 2023 | 10 | 58 | 0 | 131 |
| 2024 | 3 | 100 | 0 | 206 |
| 2025 | 6 | 58 | 0 | 153 |
| 2026 | 4 | 169 | 0 | — |
What is it indicated for?
The Synapse OCT System, including Synapse, OC Fusion and Axon, is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the…
Read the full statement (194 words)
The Synapse OCT System, including Synapse, OC Fusion and Axon, is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Synapse OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the Axon and Synapse Systems may be connected to the Synthes Universal Spinal System using parallel connectors and tapered rods. The Synapse OCT System can also be linked to the titanium DePuy EXPEDIUM Spine System using the 3.5mm/5.5mm and 4.0mm/5.5mm titanium tapered rods.
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/K142838 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142838: Synapse Occipital-Cervical-Thoracic (OCT) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142838
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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