510(k) · Cleared
ClearedS4 Cervical Spinal and Occiput Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap Implant Systems, LLC · NKG Posterior Cervical Screw System
Cleared on Oct 21, 2015 as substantially equivalent to K142838 (Synthes USA Products, LLC, 2015) after a 99-day review. Its family tree reaches back 3 generations to 1997. 2 later devices descend from it.
- Decided
- Oct 21, 2015
- Review
- 99 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K953076 (1997). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK953076 Townley Facet/Pedicular Screw Plating SystemSofamor Danek USA,Inc. · 1997
- 2 generations backK062254 Axis Fixation SystemMedtronic Sofamor Danek, Inc. · 2008
- 1 generation backK142838 Synapse Occipital-Cervical-Thoracic (OCT) SystemSynthes USA Products, LLC · 2015 · Recalled
- This deviceK151938 S4 Cervical Spinal and Occiput SystemsAesculap Implant Systems, LLC · 2015
- Descendant · cites it directly · 0 of its ownK213871 Ennovate Cervical Spinal and Occiput SystemAesculap Implant Systems, LLC · 2022
- Descendant · cites it directly · 0 of its ownK160428 Certex Spinal Fixation SystemX-Spine Systems, Inc. · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953076 | Townley Facet/Pedicular Screw Plating System | Sofamor Danek USA,Inc. | 1997 | — |
| −2 | K062254 | Axis Fixation System | Medtronic Sofamor Danek, Inc. | 2008 | — |
| −1 | K142838 | Synapse Occipital-Cervical-Thoracic (OCT) System | Synthes USA Products, LLC | 2015 | 1 |
| 0 (this device) | K151938 | S4 Cervical Spinal and Occiput Systems | Aesculap Implant Systems, LLC | 2015 | — |
| +1 | K213871 | Ennovate Cervical Spinal and Occiput System | Aesculap Implant Systems, LLC | 2022 | — |
| +1 | K160428 | Certex Spinal Fixation System | X-Spine Systems, Inc. | 2016 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2022 | 1 | 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 NKG? 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 |
|---|---|---|---|
| * | K142838 | Synapse Occipital-Cervical-Thoracic (OCT) SystemSummary page 6…mance of the predicate devices, and the device is therefore found to be substantially equivalent. PREDICATE DEVICE Synapse Occipital-Cervical-Thoracic (OCT) System (K142838) REFERENCE DEVICES Aesculap S4C Spinal System (K050979) Aesculap S4C Spinal System (Additional lengths polyaxial screws)… | 2015 |
| † | K050979 | S4 Spinal System | 2005 |
| † | K060152 | Modification to S4 Spinal System | 2006 |
| † | K062012 | S4 Cervical Occipital Plate Spinal System | 2007 |
| † | K062327 | Modification to S4 Spinal System | 2007 |
| † | K100147 | S4 Cervical Occipital Plate Spinal System | 2010 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K213871 (Aesculap Implant Systems, LLC, 2022) has gone furthest, with 0 descendants of its own.
- 31 other devices also cite its predicate K142838.
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 Aesculap S4 Cervical Spinal and Occiput Systems are 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 (Cl to C7) and the thoracic spine (Tl-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the…
Read the full statement (174 words)
The Aesculap S4 Cervical Spinal and Occiput Systems are 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 (Cl to C7) and the thoracic spine (Tl-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 Aesculap S4 Cervical Spinal and Occiput Systems are 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 Aesculap S4 Lumbar System may be connected to the Aesculap S4 Cervical Spinal and Occiput Systems using connectors and rods.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151938 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151938: S4 Cervical Spinal and Occiput Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151938
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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