510(k) · Cleared
ClearedMOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation 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 Jul 18, 2019 as substantially equivalent to K151885 (Depuy Synthes, Inc., 2015) and 4 other predicates after a 104-day review. Its family tree reaches back 5 generations to 1997. 9 later devices descend from it.
- Decided
- Jul 18, 2019
- Review
- 104 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K953076 (1997). 9 ancestors in all, the oldest K963350 (1996). 9 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK953076 Townley Facet/Pedicular Screw Plating SystemSofamor Danek USA,Inc. · 1997
- 4 generations backK062254 Axis Fixation SystemMedtronic Sofamor Danek, Inc. · 2008
- 3 generations backK142838 Synapse Occipital-Cervical-Thoracic (OCT) SystemSynthes USA Products, LLC · 2015 · Recalled
- 2 generations backK151885 SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal SystemDepuy Synthes, Inc. · 2015
- 1 generation backK181949 SYMPHONY™ OCT SystemMedos International SARL · 2018
- This deviceK190895 MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System…Medos International SARL · 2019
- Descendant · cites it directly · 3 of its ownK200936 Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc. · 2020
- Descendant · cites it directly · 3 of its ownK192014 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 ownK252597 Valence Robotic Navigation System; Valence Robotic Navigation…Alphatec Spine, Inc. · 2026
- Descendant · cites it directly · 1 of its ownK203319 SYMPHONY™ OCT SystemMedos International SARL · 2021
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc. · 2020 · cites it directly3descendants
- K192014SYPMHONY™ OCT SystemMedos International SARL · 2020 · cites it directly3descendants
- K192646SYMPHONY™ OCT SystemMedos International SARL · 2020 · cites it directly2descendants
- K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc. · 2026 · 2 generations on1descendant
- K203319SYMPHONY™ OCT SystemMedos International SARL · 2021 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K953076 | Townley Facet/Pedicular Screw Plating System | Sofamor Danek USA,Inc. | 1997 | — |
| −4 | K062254 | Axis Fixation System | Medtronic Sofamor Danek, Inc. | 2008 | — |
| −3 | K142838 | Synapse Occipital-Cervical-Thoracic (OCT) System | Synthes USA Products, LLC | 2015 | 1 |
| −2 | K151885 | SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System | Depuy Synthes, Inc. | 2015 | — |
| −1 | K181949 | SYMPHONY™ OCT System | Medos International SARL | 2018 | — |
| 0 (this device) | K190895 | MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY… | Medos International SARL | 2019 | — |
| +1 | K200936 | Invictus™ CT Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
| +1 | K192014 | SYPMHONY™ OCT System | Medos International SARL | 2020 | — |
| +1 | K192646 | SYMPHONY™ OCT System | Medos International SARL | 2020 | — |
| +2 | K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For… | Alphatec Spine, Inc. | 2026 | — |
| +1 | K203319 | SYMPHONY™ OCT System | Medos International SARL | 2021 | — |
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 | 4 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 3 | 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? (5)
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 |
|---|---|---|---|
| * | K151885 | SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal SystemSummary page 7…Page 2 of 4 D. Predicate Device Names Primary Predicate: MOUNTAINEER OCT Spinal System (K151885) Additional Predicates: SUMMIT SI OCT Spinal Fixation System (151885) SYMPHONY OC… | 2015 |
| * | K181949 | SYMPHONY™ OCT SystemSummary page 7…EER OCT Spinal System (K151885) Additional Predicates: SUMMIT SI OCT Spinal Fixation System (151885) SYMPHONY OCT System (K181949) SUMMIT Fixation System (K963350, K980368, K982483) E. Submission Purpose Obtain clea… | 2018 |
| * | K963350 | Depuy Motech Peak Fixation SystemSummary page 7…SUMMIT SI OCT Spinal Fixation System (151885) SYMPHONY OCT System (K181949) SUMMIT Fixation System (K963350, K980368, K982483) E. Submission Purpose Obtain clearance for magnetic resonance compatibility labeling of the systems l… | 1996 |
| * | K980368 | Depuy Motech Peak 3MM Fixation Rod SystemSummary page 7…OCT Spinal Fixation System (151885) SYMPHONY OCT System (K181949) SUMMIT Fixation System (K963350, K980368, K982483) E. Submission Purpose Obtain clearance for magnetic resonance compatibility labeling of the systems listed. F… | 1998 |
| * | K982483 | Depuy Motech Peak Fixation SystemSummary page 7…al Fixation System (151885) SYMPHONY OCT System (K181949) SUMMIT Fixation System (K963350, K980368, K982483) E. Submission Purpose Obtain clearance for magnetic resonance compatibility labeling of the systems listed. F. Devic… | 1998 |
What descends from it? (9)
5 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 22 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K200936 (Alphatec Spine, Inc., 2020) has gone furthest, with 3 descendants of its own.
- 10 other devices also cite its predicate K151885.
How does its category compare?
All NKG devicesNKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 SUMMIT SI OCT Spinal Fixation System and MOUNTAINEER OCT Spinal System 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 (C1 to C7) and the thoracic spine (T1-T3): • Traumatic spinal fractures and/or traumatic dislocations; • Instability or deformity; • Failed previous fusions (e.g. pseudarthrosis); •…
Read the full statement (509 words)
The SUMMIT SI OCT Spinal Fixation System and MOUNTAINEER OCT Spinal System 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 (C1 to C7) and the 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 SUMMIT and MOUNTAINEER 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.
The SONGER Wire/Cable System to be used with the SUMMIT and MOUNTAINEER Systems allows for wire/cable
attachment to the posterior cervical spine.
The SUMMIT and MOUNTAINEER Systems can also be linked to the ISOLA, MONARCH, MOSS MIAMI, VIPER
and EXPEDIUM Spine Systems using the dual wedding band and axial connectors, and via dual diameter rods.
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.
The SUMMIT Plate System is intended for use in treating fractures of small bones such as the metacarpals, ulna, radius, humerus, and metatarsals, and in treating fractures of the lateral malleoulus, olecranon, and intra-articular distal tibia.
The SUMMIT Rod System is intended for use in treating fractures of the pelvis, acetabulum, clavicle, scapula, and distal humerus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190895 · printed Nov 3, 2026
Cite this page
510(k) Report. “K190895: MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K190895
Report an extraction error
Are you the manufacturer?
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