510(k) · Cleared

Cleared

Summit Oct Spinal System Minipolyaxial Screws

K030103510(k) SpecialCleared Feb 5, 200323-day reviewClass II21 CFR 888.3070

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

Depuyacromed · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Feb 5, 2003 as substantially equivalent to K002733 (Depuyacromed, 2000) and 3 other predicates after a 23-day review. Its family tree reaches back 6 generations to 1985. 2 of the 671 devices in its family, counting itself, have a Class I recall. 658 later devices descend from it.

Decided: Feb 5, 2003
Review: 23 days
Class: Class II
Product code: MNI
Recalls: None
Predicates: 4

Its longest line of descent runs back 6 generations to K853033 (1985). 12 ancestors in all. 658 later devices descend from it, 7 citing it directly. 2 of the 671 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 6 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
5 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
4 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
3 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
2 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
1 generation backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
This deviceK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
Descendant · cites it directly · 657 of its ownK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
Descendant · 2 generations on · 490 of its ownK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
Descendant · 3 generations on · 424 of its ownK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
Descendant · 3 generations on · 398 of its ownK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
Descendant · 3 generations on · 397 of its ownK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008

Showing 5 of 658 descendants. See all descendants

Descendants cleared per year

2004high 66 (2023) · low 2 (2004)2026

Class I recalls in this family

K093670 Modification to: Oasys System2 generations on · 2010
K211616 ExcelsiusHub5 generations on · 2021

Most influential descendants

Showing 5 of 658 · See all

K041203Summit Oct Spinal SystemDepuy Spine, Inc. · 2004 · cites it directly657descendants
K062174Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006 · 2 generations on490descendants
K063156Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006 · 3 generations on424descendants
K063741Expedium Spine SystemDepuy Spine, Inc. · 2007 · 3 generations on398descendants
K080313Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008 · 3 generations on397descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K853033	Hartshill Rect & Wires, Spinal Fixation System	A.W. Showell (Surgicraft), Ltd.	1985	—
−5	K965221	Ransford Cervical Fixation System	Surgicraft, Ltd.	1997	—
−4	K982322	Synthes Spine Occipital-Cervical Plate/Rod and Hook System	Synthes (Usa)	1998	—
−3	K002733	Summit Occipito-Cervico-Thoracic (Oct) Spinal System	Depuyacromed	2000	—
−2	K013222	Summit Occipito-Cervico- Thoracic (Oct) Spinal System	Depuyacromed	2001	—
−1	K022190	Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System	Depuyacromed	2002	—
0 (this device)	K030103	Summit Oct Spinal System Minipolyaxial Screws	Depuyacromed	2003	—
+1	K041203	Summit Oct Spinal System	Depuy Spine, Inc.	2004	—
+2	K062174	Modification to Expedium Spine System	Depuy Spine, Inc.	2006	—
+3	K063156	Modification to Expedium Spine System	Depuy Spine, Inc.	2006	—
+3	K063741	Expedium Spine System	Depuy Spine, Inc.	2007	—
+3	K080313	Modification to Expedium Spine System	Depuy Spine, Inc.	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	4	0
2000	1	0
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	2	0
2005	2	0
2006	4	0
2007	6	0
2008	13	0
2009	10	0
2010	12	1
2011	15	0
2012	28	0
2013	30	0
2014	31	0
2015	38	0
2016	29	0
2017	37	0
2018	38	0
2019	32	0
2020	38	0
2021	33	1
2022	38	0
2023	66	0
2024	57	0
2025	50	0
2026	49	0

FIG. 1 — Lineage of K030103, 1985–2026Source: 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.

2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (4)

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
*	K002733	Summit Occipito-Cervico-Thoracic (Oct) Spinal System Summary page 1 …Orthosis, Spinal Pedicle Fixation PROPRIETARY NAME: Summit OCT Spinal System Minipolyaxial Screws PREDICATE DEVICES: Summit OCT Spinal System (K002733, KO10681, K013222, K022190) DEVICE DESCRIPTION: The Summit OCT Spinal System Minipolyaxial…	Depuyacromed	2000	—
*	K010681	Summit Occipito-Cervico-Thoracic (Oct) Spinal System	Depuyacromed	2001	—
*	K013222	Summit Occipito-Cervico- Thoracic (Oct) Spinal System Summary page 1 …IETARY NAME: Summit OCT Spinal System Minipolyaxial Screws PREDICATE DEVICES: Summit OCT Spinal System (K002733, KO10681, K013222, K022190) DEVICE DESCRIPTION: The Summit OCT Spinal System Minipolyaxial Screws are designed to accept a 3.0…	Depuyacromed	2001	—
*	K022190	Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System Summary page 1 …ME: Summit OCT Spinal System Minipolyaxial Screws PREDICATE DEVICES: Summit OCT Spinal System (K002733, KO10681, K013222, K022190) DEVICE DESCRIPTION: The Summit OCT Spinal System Minipolyaxial Screws are designed to accept a 3.0mm rod an…	Depuyacromed	2002	—

Also cleared against K002733: 15 other devices →

What descends from it? (658)

See all 658

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

Number	Device	Applicant	Decided	Descendants
K041203	Summit Oct Spinal System	Depuy Spine, Inc.	2004	657
K042508	Sumit Oct Spinal System and Mountaineer Oct Spinal System	Depuy Spine, Inc.	2004	301
K080828	Mountaineer Oct Spinal System	Depuy Spine, Inc.	2008	242
K050979	S4 Spinal System	Aesculap, Inc.	2005	67
K072568	Modification to Oasys System	Stryker Spine	2007	44
K062934	Sierra	Seaspine, Inc.	2006	21
K181350	ASTRA-OCT Spine System	Spinecraft, LLC	2018	0

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

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.

K093670Modification to: Oasys SystemStryker Spine · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 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 4 companies; a new generation was cleared every 1.3 years on median.
None of the 12 ancestors has a recall.
Of its descendants, K041203 (Depuy Spine, Inc., 2004) has gone furthest, with 657 descendants of its own.
15 other devices also cite its predicate K002733.

How does its category compare?

All MNI devices

MNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MNI

1in 2017

2007high 23 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNI

168in 2016

2007high 168 (2016) · low 54 (2015)2026

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

Recalls per year · MNI

1in 2018

2007high 26 (2007) · low 0 (2011)2026

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

Adverse event reports per year · MNI

80in 2025

2007high 824 (2013) · low 80 (2025)2025

MAUDE reports naming product code MNI, 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	20	82	26	83
2008	23	64	8	108
2009	18	86	3	138
2010	16	74	1	126
2011	17	111	0	146
2012	19	75	1	200
2013	14	77	4	824
2014	6	104	0	301
2015	12	54	1	260
2016	7	168	0	117
2017	1	—	0	247
2018	0	—	1	134
2019	0	—	0	188
2020	0	—	0	115
2021	0	—	0	270
2022	0	—	0	214
2023	0	—	0	122
2024	0	—	0	114
2025	0	—	0	80
2026	0	—	0	—

What is it indicated for?

The indications for use for the modified devices described in this submission are the same as those for the Summit OCT Spinal System (KO22190). The indications are as follows: When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput - T3), the Summit Occipito-Cervical-Thoracic (OCT) Spinal System is intended for: ddd (neck pain of discogenic origin with degeneration of the dislc as confirmed by patient history…

Read the full statement (184 words)

The indications for use for the modified devices described in this submission are the same as those for the Summit OCT Spinal System (KO22190). The indications are as follows:

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput - T3), the Summit Occipito-Cervical-Thoracic (OCT) Spinal System is intended for:

ddd (neck pain of discogenic origin with degeneration of the dislc as confirmed by patient history and radiographic studies)

spondylolisthesis

spinal stenosis

fracture/dislocation

atlanto/axial fracture with instability

occipitocervical dislocation

revision of previous cervical spine surgery

tumors

The occipital bone screws are limited to occipital fixation only.

The use of the minipolyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The Songer Cable System, to be used with the Summit OCT Spinal System, allows for wirekable attachment to the posterior cervical spine.

The Summit OCT Spinal System can also be linked to the ISOLA, TiMX, MONARCH and MOSS MIAMI Systems using the dual wedding band and axial connectors, and via dual diameter rods.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030103 · printed Nov 5, 2026

Cite this page

510(k) Report. “K030103: Summit Oct Spinal System Minipolyaxial Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030103

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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