510(k) · Cleared

Cleared

Stryker Spine Oasys System

K032394510(k) TraditionalCleared Feb 20, 2004200-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

Howmedica Osteonics Corp. · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Feb 20, 2004 after a 200-day review. The FDA summary names no predicate by number. 2 of the 231 devices in its family, counting itself, have a Class I recall. 230 later devices descend from it.

Decided: Feb 20, 2004
Review: 200 days
Class: Class II
Product code: MNI
Recalls: None
Predicates: 0

230 later devices descend from it, 14 citing it directly. 2 of the 231 devices in this family, counting this one, have a Class I recall.

This deviceK032394 Stryker Spine Oasys SystemHowmedica Osteonics Corp. · 2004
Descendant · cites it directly · 148 of its ownK050391 Protex CT Cervicothoracic Spinal SystemGlobus Medical, Inc. · 2005
Descendant · 2 generations on · 104 of its ownK081906 Protex CT Cervicothoracic Spinal SystemGlobus Medical, Inc. · 2008
Descendant · cites it directly · 101 of its ownK090565 Ellipse Occipito-Cerico-Thoracic Spinal SystemGlobus Medical, Inc. · 2009
Descendant · 2 generations on · 98 of its ownK110963 Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc. · 2011
Descendant · 2 generations on · 97 of its ownK123783 Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc. · 2013

Showing 5 of 230 descendants. See all descendants

Descendants cleared per year

2005high 26 (2024) · low 1 (2006)2026

Class I recalls in this family

K093670 Modification to: Oasys Systemcites it directly · 2010
K211616 ExcelsiusHub4 generations on · 2021

Most influential descendants

Showing 5 of 230 · See all

K050391Protex CT Cervicothoracic Spinal SystemGlobus Medical, Inc. · 2005 · cites it directly148descendants
K081906Protex CT Cervicothoracic Spinal SystemGlobus Medical, Inc. · 2008 · 2 generations on104descendants
K090565Ellipse Occipito-Cerico-Thoracic Spinal SystemGlobus Medical, Inc. · 2009 · cites it directly101descendants
K110963Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc. · 2011 · 2 generations on98descendants
K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc. · 2013 · 2 generations on97descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K032394	Stryker Spine Oasys System	Howmedica Osteonics Corp.	2004	—
+1	K050391	Protex CT Cervicothoracic Spinal System	Globus Medical, Inc.	2005	—
+2	K081906	Protex CT Cervicothoracic Spinal System	Globus Medical, Inc.	2008	—
+1	K090565	Ellipse Occipito-Cerico-Thoracic Spinal System	Globus Medical, Inc.	2009	—
+2	K110963	Ellipse Occipito-Cervico-Thoracic Spinal System	Globus Medical, Inc.	2011	—
+2	K123783	Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol Implants	Globus Medical, Inc.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	2	0
2006	1	0
2007	2	0
2008	3	0
2009	4	0
2010	6	1
2011	4	0
2012	9	0
2013	4	0
2014	11	0
2015	19	0
2016	11	0
2017	7	0
2018	12	0
2019	8	0
2020	14	0
2021	10	1
2022	12	0
2023	25	0
2024	26	0
2025	17	0
2026	23	0

FIG. 1 — Lineage of K032394, 2004–2026Source: 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?

The FDA summary names no predicate by number.

What descends from it? (230)

See all 230

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

Number	Device	Applicant	Decided	Descendants
K050391	Protex CT Cervicothoracic Spinal System	Globus Medical, Inc.	2005	148
K090565	Ellipse Occipito-Cerico-Thoracic Spinal System	Globus Medical, Inc.	2009	101
K052317	Modification to: Stryker Spine Oasys System	Stryker Spine	2005	61
K062853	Modification to Stryker Spine Oasys System	Stryker Spine	2006	53
K072568	Modification to Oasys System	Stryker Spine	2007	44
K080143	Modification to Stryker Spine Oasys System	Stryker Spine	2008	43
K093670	Modification to: Oasys System Class I	Stryker Spine	2010	41
K111719	Oasys Spinal System	Stryker Spine	2012	39
K092295	Pioneer Posterior Cervico-Thoracic System	Pioneer Surgical Technology	2010	24
K090343	Sentinel Spinal System	Life Spine	2009	21

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 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K050391 (Globus Medical, Inc., 2005) has gone furthest, with 148 descendants of its own.

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?

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput-T3), the Stryker Spine Oasys System is intended for: * Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) * Spondylolisthesis * Spinal Stenosis * Fracture/Dislocation * Atlanto/axial fracture with instability * Occipitocervical dislocation *…

Read the full statement (175 words)

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput-T3), the Stryker Spine Oasys System is intended for:

* Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)

* Spondylolisthesis

* Spinal Stenosis

* Fracture/Dislocation

* Atlanto/axial fracture with instability

* Occipitocervical dislocation

* Revision of previous cervical spine surgery

* Tumors

When used with the occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.

The use of the polyaxial 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 hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

The Stryker Spine Oasys System can also be linked to the Xia Spinal System via the rod to rod connector

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032394 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032394: Stryker Spine Oasys System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032394

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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