510(k) · Cleared
ClearedSYPMHONY™ OCT System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medos International SARL · NKG Posterior Cervical Screw System
Cleared on Jan 24, 2020 as substantially equivalent to K181949 (Medos International SARL, 2018) and 1 other predicate after a 179-day review. Its family tree reaches back 6 generations to 1997. 3 later devices descend from it.
- Decided
- Jan 24, 2020
- Review
- 179 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K953076 (1997). 10 ancestors in all, the oldest K963350 (1996). 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK953076 Townley Facet/Pedicular Screw Plating SystemSofamor Danek USA,Inc. · 1997
- 5 generations backK062254 Axis Fixation SystemMedtronic Sofamor Danek, Inc. · 2008
- 4 generations backK142838 Synapse Occipital-Cervical-Thoracic (OCT) SystemSynthes USA Products, LLC · 2015 · Recalled
- 3 generations backK151885 SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal SystemDepuy Synthes, Inc. · 2015
- 2 generations backK181949 SYMPHONY™ OCT SystemMedos International SARL · 2018
- 1 generation backK190895 MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System…Medos International SARL · 2019
- This deviceK192014 SYPMHONY™ OCT SystemMedos International SARL · 2020
- Descendant · cites it directly · 2 of its ownK192646 SYMPHONY™ OCT SystemMedos International SARL · 2020
- Descendant · 2 generations on · 1 of its ownK203319 SYMPHONY™ OCT SystemMedos International SARL · 2021
- Descendant · 2 generations on · 0 of its ownK233366 SYMPHONY OCT SystemMedos International SARL · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K953076 | Townley Facet/Pedicular Screw Plating System | Sofamor Danek USA,Inc. | 1997 | — |
| −5 | K062254 | Axis Fixation System | Medtronic Sofamor Danek, Inc. | 2008 | — |
| −4 | K142838 | Synapse Occipital-Cervical-Thoracic (OCT) System | Synthes USA Products, LLC | 2015 | 1 |
| −3 | K151885 | SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System | Depuy Synthes, Inc. | 2015 | — |
| −2 | K181949 | SYMPHONY™ OCT System | Medos International SARL | 2018 | — |
| −1 | K190895 | MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY… | Medos International SARL | 2019 | — |
| 0 (this device) | K192014 | SYPMHONY™ OCT System | Medos International SARL | 2020 | — |
| +1 | K192646 | SYMPHONY™ OCT System | Medos International SARL | 2020 | — |
| +2 | K203319 | SYMPHONY™ OCT System | Medos International SARL | 2021 | — |
| +2 | K233366 | SYMPHONY OCT System | Medos International SARL | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K181949 | SYMPHONY™ OCT SystemSummary page 4…1 CFR §888.3050 Appliance, Fixation, Spinal Interlaminal D. Predicate Device Names Primary Predicate: SYMPHONY OCT System (K181949, K190895) K192014… | 2018 |
| * | K190895 | MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT…Summary page 4…8.3050 Appliance, Fixation, Spinal Interlaminal D. Predicate Device Names Primary Predicate: SYMPHONY OCT System (K181949, K190895) K192014… | 2019 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192646 | SYMPHONY™ OCT System | 2020 | 2 |
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 23 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K192646 (Medos International SARL, 2020) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K181949.
How does its category compare?
All NKG devicesNKG Posterior Cervical 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 · 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 SYMPHONY OCT System 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 upper thoracic spine (T1-T3): • Traumatic spinal fractures and/or traumatic dislocations; • Instability or deformity; • Failed previous fusions (e.g. pseudarthrosis); • Tumors involving the cervical/thoracic spine…
Read the full statement (247 words)
The SYMPHONY OCT System 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 upper thoracic spine (T1-T3):
• Traumatic spinal fractures and/or traumatic dislocations;
• Instability or deformity;
• Failed previous fusions (e.g. pseudarthrosis);
• Tumors involving the cervical/thoracic spine;
• 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 SYMPHONY 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.
The SYMPHONY OCT System is compatible with occipital fusion components (plates, rods and clamps) from the
SYNAPSE Occipital-Cervical-Thoracic (OCT) System and the MOUNTAINEER OCT Spinal System. Additionally, the
SYMPHONY OCT System is compatible with SYNAPSE OCT System hooks and rods.
The SONGER Wire/Cable System may be used with the SYMPHONY OCT System to allow for wire/cable attachment to
the posterior cervical spine.
The SYMPHONY OCT System may be connected to the EXPEDIUM Spine System and VIPER System using connectors
and tapered rods. The SYMPHONY OCT System can also be linked to the USS Spinal System and MATRIX Spine
System using connectors and tapered rods.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192014 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192014: SYPMHONY™ 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/K192014
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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