510(k) · Cleared

Cleared

SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System

K151885510(k) TraditionalCleared Sep 3, 201556-day reviewClass II21 CFR 888.3075

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Depuy Synthes, Inc. · NKG Posterior Cervical Screw System

Cleared on Sep 3, 2015 as substantially equivalent to K142838 (Synthes USA Products, LLC, 2015) after a 56-day review. Its family tree reaches back 3 generations to 1997. 41 later devices descend from it.

Decided: Sep 3, 2015
Review: 56 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. 41 later devices descend from it, 11 citing it directly.

By dateBy generation

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 deviceK151885 SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal SystemDepuy Synthes, Inc. · 2015
Descendant · cites it directly · 26 of its ownK150474 NuVasive VuePoint II OCT SystemNu Vasive, Incorporated · 2015
Descendant · cites it directly · 17 of its ownK153370 Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated · 2016
Descendant · 2 generations on · 13 of its ownK171444 YUKON OCT Spinal SystemK2m, Inc. · 2017 · Recalled
Descendant · cites it directly · 10 of its ownK181949 SYMPHONY™ OCT SystemMedos International SARL · 2018
Descendant · cites it directly · 9 of its ownK190895 MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System…Medos International SARL · 2019

Showing 5 of 41 descendants. See all descendants

Descendants cleared per year

2015high 7 (2020) · low 1 (2015)2026

Most influential descendants

Showing 5 of 41 · See all

K150474NuVasive VuePoint II OCT SystemNu Vasive, Incorporated · 2015 · cites it directly26descendants
K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated · 2016 · cites it directly17descendants
K171444YUKON OCT Spinal SystemK2m, Inc. · 2017 · 2 generations on13descendants
K181949SYMPHONY™ OCT SystemMedos International SARL · 2018 · cites it directly10descendants
K190895MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT…Medos International SARL · 2019 · cites it directly9descendants

View 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)	K151885	SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System	Depuy Synthes, Inc.	2015	—
+1	K150474	NuVasive VuePoint II OCT System	Nu Vasive, Incorporated	2015	—
+1	K153370	Caspian OCT/MESA Mini/DENALI Mini Spinal System	K2m, Incorporated	2016	—
+2	K171444	YUKON OCT Spinal System	K2m, Inc.	2017	3
+1	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	—

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	1	0
2016	3	0
2017	3	0
2018	5	0
2019	2	0
2020	7	0
2021	2	0
2022	4	0
2023	2	0
2024	4	0
2025	2	0
2026	6	0

FIG. 1 — Lineage of K151885, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K142838	Synapse Occipital-Cervical-Thoracic (OCT) System Summary page 4 …8.3050 D. Predicate Device Name Primary Predicate Device: Synapse Occipital-Cervical-Thoracic (OCT) System (K142838) Reference Devices: MOUNTAINEER® OCT Spinal System (most recently…	Synthes USA Products, LLC	2015	1
†	K132332	Mountaineer Oct Spinal System	Medos International SARL	2013	—
†	K042508	Sumit Oct Spinal System and Mountaineer Oct Spinal System	Depuy Spine, Inc.	2004	—

Also cleared against K142838: 31 other devices →

What descends from it? (41)

See all 41

11 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K150474	NuVasive VuePoint II OCT System	Nu Vasive, Incorporated	2015	26
K153370	Caspian OCT/MESA Mini/DENALI Mini Spinal System	K2m, Incorporated	2016	17
K181949	SYMPHONY™ OCT System	Medos International SARL	2018	10
K190895	MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT…	Medos International SARL	2019	9
K192013	VERTICALE® Cervical System	Silony Medical GmbH	2020	2
K192646	SYMPHONY™ OCT System	Medos International SARL	2020	2
K203319	SYMPHONY™ OCT System	Medos International SARL	2021	1
K161498	Streamline OCT Occipito-Cervico-Thoracic System	Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)	2016	1
K200571	PERLA® Posterior Occipito-Cervico-Thoracic Fixation System	Spineart	2020	0
K181350	ASTRA-OCT Spine System	Spinecraft, LLC	2018	0

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, K150474 (Nu Vasive, Incorporated, 2015) has gone furthest, with 26 descendants of its own.
31 other devices also cite its predicate K142838.

How does its category compare?

All NKG devices

NKG 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

2007high 17 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKG

58in 2025

2007high 169 (2026) · low 50 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NKG

2in 2020

2007high 2 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NKG

153in 2025

2007high 704 (2021) · low 0 (2007)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 (207 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;

« 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 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.

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/K151885 · printed Nov 5, 2026

Cite this page

510(k) Report. “K151885: SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K151885

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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