510(k) · Cleared

Cleared

Summit Occipito-Cervico-Thoracic (Oct) Spinal System

K010681510(k) TraditionalCleared Jul 18, 2001133-day reviewClass II21 CFR 888.3050

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

Depuyacromed · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Jul 18, 2001 after a 133-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 680 devices in its family, counting itself, have a Class I recall. 679 later devices descend from it.

Decided: Jul 18, 2001
Review: 133 days
Class: Class II
Product code: KWP
Recalls: None
Predicates: 0

679 later devices descend from it, 10 citing it directly. 2 of the 680 devices in this family, counting this one, have a Class I recall.

This deviceK010681 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2001
Descendant · cites it directly · 660 of its ownK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
Descendant · cites it directly · 659 of its ownK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
Descendant · cites it directly · 658 of its ownK030103 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

Showing 5 of 679 descendants. See all descendants

Descendants cleared per year

2001high 67 (2023) · low 1 (2001)2026

Class I recalls in this family

K093670 Modification to: Oasys System3 generations on · 2010
K211616 ExcelsiusHub5 generations on · 2021

Most influential descendants

Showing 5 of 679 · See all

K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001 · cites it directly660descendants
K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002 · cites it directly659descendants
K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003 · cites it directly658descendants
K041203Summit Oct Spinal SystemDepuy Spine, Inc. · 2004 · cites it directly657descendants
K062174Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006 · 2 generations on490descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010681	Summit Occipito-Cervico-Thoracic (Oct) Spinal System	Depuyacromed	2001	—
+1	K013222	Summit Occipito-Cervico- Thoracic (Oct) Spinal System	Depuyacromed	2001	—
+1	K022190	Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System	Depuyacromed	2002	—
+1	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	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	1	0
2003	1	0
2004	2	0
2005	4	0
2006	5	0
2007	8	0
2008	13	0
2009	13	0
2010	12	1
2011	16	0
2012	28	0
2013	31	0
2014	32	0
2015	38	0
2016	29	0
2017	38	0
2018	39	0
2019	32	0
2020	39	0
2021	33	1
2022	38	0
2023	67	0
2024	57	0
2025	52	0
2026	50	0

FIG. 1 — Lineage of K010681, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (679)

See all 679

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

Number	Device	Applicant	Decided	Descendants
K013222	Summit Occipito-Cervico- Thoracic (Oct) Spinal System	Depuyacromed	2001	660
K022190	Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System	Depuyacromed	2002	659
K030103	Summit Oct Spinal System Minipolyaxial Screws	Depuyacromed	2003	658
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
K052402	Vertex Reconstruction System	Medtronic Sofamor Danek	2005	180
K090343	Sentinel Spinal System	Life Spine	2009	21
K062934	Sierra	Seaspine, Inc.	2006	21
K120467	Spinal Elements Posterior Cervical/Thoracic Spinal System	Spinal Elements, Inc.	2012	1

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 · 3 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?

Of its descendants, K013222 (Depuyacromed, 2001) has gone furthest, with 660 descendants of its own.

How does its category compare?

All KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWP

9in 2015

2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007high 186 (2010) · low 50 (2008)2026

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

Recalls per year · KWP

2in 2022

2007high 23 (2009) · low 0 (2014)2026

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

Adverse event reports per year · KWP

494in 2025

2007high 1,379 (2016) · low 210 (2007)2025

MAUDE reports naming product code KWP, 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	14	96	2	210
2008	13	50	1	594
2009	12	89	23	682
2010	14	186	2	474
2011	12	67	6	792
2012	18	112	1	918
2013	12	99	3	1,090
2014	13	138	0	1,022
2015	9	113	1	1,348
2016	0	—	3	1,379
2017	0	—	0	864
2018	0	—	1	657
2019	0	—	2	518
2020	0	—	0	796
2021	0	—	0	525
2022	0	—	2	335
2023	0	—	0	332
2024	0	—	0	436
2025	0	—	0	494
2026	0	—	0	—

https://510kreport.com/device/K010681 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010681: Summit Occipito-Cervico-Thoracic (Oct) Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010681

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026