510(k) Report

510(k) · Cleared

Cleared

Modification to: Stryker Spine Oasys System

K052317510(k) SpecialCleared Sep 21, 200527-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

Stryker Spine · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Sep 21, 2005 as substantially equivalent to K032394 (Howmedica Osteonics Corp., 2004) after a 27-day review. Its family tree reaches back 1 generation to 2004. 1 of the 63 devices in its family, counting itself, has a Class I recall. 61 later devices descend from it.

Decided
Sep 21, 2005
Review
27 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K032394 (2004). 61 later devices descend from it, 7 citing it directly. 1 of the 63 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2008: 2 descendants cleared2012: 2 descendants cleared2006: 1 descendant cleared2010: 4 descendants cleared, 1 with a Class I recall12007: 2 descendants cleared2011: 2 descendants cleared2014: 1 descendant cleared2009: 2 descendants cleared2020: 5 descendants cleared2015: 4 descendants cleared2016: 5 descendants cleared2023: 10 descendants cleared2019: 1 descendant cleared2018: 3 descendants cleared2025: 2 descendants cleared2017: 1 descendant cleared2024: 5 descendants cleared2022: 2 descendants cleared2021: 1 descendant cleared2026: 6 descendants clearedK032394 · Stryker Spine Oasys System · Howmedica Osteonics Corp. · 2004200020052010201520202025
Descendants, by generation 1 generation forward: 7 descendants, 1 with a Class I recall12 generations forward: 9 descendants3 generations forward: 6 descendants4 generations forward: 6 descendants5 generations forward: 7 descendants6 generations forward: 9 descendants7 generations forward: 7 descendants8 generations forward: 6 descendants9 generations forward: 4 descendants K032394 · Stryker Spine Oasys System · Howmedica Osteonics Corp. · 20040+5
  1. Root · 1 generation backK032394 Stryker Spine Oasys SystemHowmedica Osteonics Corp. · 2004
  2. This deviceK052317 Modification to: Stryker Spine Oasys SystemStryker Spine · 2005
  3. Descendant · cites it directly · 53 of its ownK062853 Modification to Stryker Spine Oasys SystemStryker Spine · 2006
  4. Descendant · cites it directly · 44 of its ownK072568 Modification to Oasys SystemStryker Spine · 2007
  5. Descendant · cites it directly · 43 of its ownK080143 Modification to Stryker Spine Oasys SystemStryker Spine · 2008
  6. Descendant · cites it directly · 41 of its ownK093670 Modification to: Oasys SystemStryker Spine · 2010 · Recalled (Class I)
  7. Descendant · cites it directly · 39 of its ownK111719 Oasys Spinal SystemStryker Spine · 2012

Showing 5 of 61 descendants. See all descendants

Descendants cleared per year

2006: 12007: 22008: 22009: 22010: 42011: 22012: 22014: 12015: 42016: 52017: 12018: 32019: 12020: 52021: 12022: 22023: 102024: 52025: 22026: 6
2006high 10 (2023) · low 0 (2013)2026

Class I recalls in this family

  • K093670 Modification to: Oasys Systemcites it directly · 2010

Most influential descendants

Showing 5 of 61 · See all
  • K062853Modification to Stryker Spine Oasys SystemStryker Spine · 2006 · cites it directly53descendants
  • K072568Modification to Oasys SystemStryker Spine · 2007 · cites it directly44descendants
  • K080143Modification to Stryker Spine Oasys SystemStryker Spine · 2008 · cites it directly43descendants
  • K093670Modification to: Oasys SystemStryker Spine · 2010 · cites it directly41descendants
  • K111719Oasys Spinal SystemStryker Spine · 2012 · cites it directly39descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K032394Stryker Spine Oasys SystemHowmedica Osteonics Corp.2004—
0 (this device)K052317Modification to: Stryker Spine Oasys SystemStryker Spine2005—
+1K062853Modification to Stryker Spine Oasys SystemStryker Spine2006—
+1K072568Modification to Oasys SystemStryker Spine2007—
+1K080143Modification to Stryker Spine Oasys SystemStryker Spine2008—
+1K093670Modification to: Oasys SystemStryker Spine2010Class I
+1K111719Oasys Spinal SystemStryker Spine2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200720
200820
200920
201041
201120
201220
201410
201540
201650
201710
201830
201910
202050
202110
202220
2023100
202450
202520
202660
FIG. 1 — Lineage of K052317, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

1 device in this family has 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K032394Stryker Spine Oasys System
Summary page 1
…Pedicle Screw Spinal System 21 CFR §888.3070 Predicate Device Information: K032394 Stryker Spine OASYSR System The Stryker Spine OASYSTM System is comprised of rods, polyaxial screws, bone screws, hooks, connecto…
Howmedica Osteonics Corp.2004—

Also cleared against K032394: 13 other devices →

What descends from it? (61)

See all 61

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

NumberDeviceApplicantDecidedDescendants
K062853Modification to Stryker Spine Oasys SystemStryker Spine200653
K072568Modification to Oasys SystemStryker Spine200744
K080143Modification to Stryker Spine Oasys SystemStryker Spine200843
K093670Modification to: Oasys System Class IStryker Spine201041
K111719Oasys Spinal SystemStryker Spine201239
K071905Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC20076
K101183Modification to: Oasys SystemStryker Spine20100

Has anything in its family been recalled? (1 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

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K062853 (Stryker Spine, 2006) has gone furthest, with 53 descendants of its own.
  • 13 other devices also cite its predicate K032394.

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

2007: 202008: 232009: 182010: 162011: 172012: 192013: 142014: 62015: 122016: 72017: 1
2007high 23 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNI

168in 2016

2007: 82 days median2008: 64 days median2009: 86 days median2010: 74 days median2011: 111 days median2012: 75 days median2013: 77 days median2014: 104 days median2015: 54 days median2016: 168 days median
2007high 168 (2016) · low 54 (2015)2026

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

Recalls per year · MNI

1in 2018

2007: 262008: 82009: 32010: 12012: 12013: 42015: 12018: 1
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

2007: 832008: 1082009: 1382010: 1262011: 1462012: 2002013: 8242014: 3012015: 2602016: 1172017: 2472018: 1342019: 1882020: 1152021: 2702022: 2142023: 1222024: 1142025: 80
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200720822683
200823648108
200918863138
201016741126
2011171110146
201219751200
201314774824
201461040301
201512541260
201671680117
20171—0247
20180—1134
20190—0188
20200—0115
20210—0270
20220—0214
20230—0122
20240—0114
20250—080
20260—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 OASYSTM 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 (178 words)

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the Stryker Spine OASYSTM 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 be linked to the Xia Spinal System and SR90D System via the rod-to-rod connectors.

Indications for use as stated in the FDA summary.

Also cleared against K032394

13 other devices cite the same predicate.

  • K193129Yukon OCT Spinal SystemK2m, Inc. · 20201 recall
  • K111719Oasys Spinal SystemStryker Spine · 2012
  • K101183Modification to: Oasys SystemStryker Spine · 2010
  • K093670Modification to: Oasys SystemStryker Spine · 20101 Class I recall
  • K092295Pioneer Posterior Cervico-Thoracic SystemPioneer Surgical Technology · 2010
  • K091359Gso PCT Spinal SystemGold Standard Orthopaedics, LLC · 2009

More from Stryker Spine

92 FDA decisions under this applicant name. See the company

  • K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero®…Stryker Spine · 2026
  • K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute…Stryker Spine · 2026
  • K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System…Stryker Spine · 2024
  • K242280Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute…Stryker Spine · 2024
  • K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA®…Stryker Spine · 2023

Recent decisions in MNI

The MNI category page

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  • K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd. · 2016
  • K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc. · 2016
  • K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A. · 2016
  • K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A. · 2016

https://510kreport.com/device/K052317 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052317: Modification to: 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/K052317

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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