510(k) · Cleared
ClearedModification to Stryker Spine Oasys System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Spine · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Oct 24, 2006 as substantially equivalent to K032394 (Howmedica Osteonics Corp., 2004) and 1 other predicate after a 29-day review. Its family tree reaches back 2 generations to 2004. 1 of the 56 devices in its family, counting itself, has a Class I recall. 53 later devices descend from it.
- Decided
- Oct 24, 2006
- Review
- 29 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K032394 (2004). 53 later devices descend from it, 6 citing it directly. 1 of the 56 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK032394 Stryker Spine Oasys SystemHowmedica Osteonics Corp. · 2004
- 1 generation backK052317 Modification to: Stryker Spine Oasys SystemStryker Spine · 2005
- This deviceK062853 Modification to Stryker Spine Oasys SystemStryker Spine · 2006
- Descendant · cites it directly · 44 of its ownK072568 Modification to Oasys SystemStryker Spine · 2007
- Descendant · cites it directly · 43 of its ownK080143 Modification to Stryker Spine Oasys SystemStryker Spine · 2008
- Descendant · cites it directly · 41 of its ownK093670 Modification to: Oasys SystemStryker Spine · 2010 · Recalled (Class I)
- Descendant · cites it directly · 39 of its ownK111719 Oasys Spinal SystemStryker Spine · 2012
- Descendant · 2 generations on · 37 of its ownK142741 OASYS SystemStryker Corporation · 2015
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K093670 Modification to: Oasys Systemcites it directly · 2010
Most influential descendants
Showing 5 of 53 · See all- 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
- K142741OASYS SystemStryker Corporation · 2015 · 2 generations on37descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K032394 | Stryker Spine Oasys System | Howmedica Osteonics Corp. | 2004 | — |
| −1 | K052317 | Modification to: Stryker Spine Oasys System | Stryker Spine | 2005 | — |
| 0 (this device) | K062853 | Modification to Stryker Spine Oasys System | Stryker Spine | 2006 | — |
| +1 | K072568 | Modification to Oasys System | Stryker Spine | 2007 | — |
| +1 | K080143 | Modification to Stryker Spine Oasys System | Stryker Spine | 2008 | — |
| +1 | K093670 | Modification to: Oasys System | Stryker Spine | 2010 | Class I |
| +1 | K111719 | Oasys Spinal System | Stryker Spine | 2012 | — |
| +2 | K142741 | OASYS System | Stryker Corporation | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 1 |
| 2012 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 5 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 5 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 10 | 0 |
| 2024 | 5 | 0 |
| 2025 | 2 | 0 |
| 2026 | 6 | 0 |
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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K032394 | Stryker Spine Oasys SystemSummary page 1…ail: Simona.Voic~stryker.com Date Summary Prepared: September 22, 2006 Predicate Device Identification Stryker Spine OASYSTM System: K032394 & K0523 17 Predicate Device Description The Stryker Spine OASYSfM System is comprised of rods, polyaxial screws, bone screws, ho… | 2004 |
| * | K052317 | Modification to: Stryker Spine Oasys SystemSummary page 1…a.Voic~stryker.com Date Summary Prepared: September 22, 2006 Predicate Device Identification Stryker Spine OASYSTM System: K032394 & K0523 17 Predicate Device Description The Stryker Spine OASYSfM System is comprised of rods, polyaxial screws, bone screws, hooks, connec… | 2005 |
| † | K050461 | Xia 4.5 Spinal System | 2005 |
| † | K060361 | Xia Spinal System, Xia 4.5 Spinal System | 2006 |
What descends from it? (53)
See all 536 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K072568 (Stryker Spine, 2007) has gone furthest, with 44 descendants of its own.
- 13 other devices also cite its predicate K032394.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 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 or 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 (179 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 or 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 (TI-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 (Cl-T3) spine.
The Stryker Spine OASYS™ System can also be linked to the Xia System, SR90D System and Xia 4.5 Spinal System via the rod-to-rod connectors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062853 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062853: 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/K062853
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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