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 Feb 14, 2008 as substantially equivalent to K032394 (Howmedica Osteonics Corp., 2004) and 3 other predicates after a 23-day review. Its family tree reaches back 9 generations to 1985. 1 of the 62 devices in its family, counting itself, has a Class I recall. 43 later devices descend from it.
- Decided
- Feb 14, 2008
- Review
- 23 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K853033 (1985). 18 ancestors in all. 43 later devices descend from it, 5 citing it directly. 1 of the 62 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 5 generations between
- 3 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 2 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 1 generation backK072568 Modification to Oasys SystemStryker Spine · 2007
- This deviceK080143 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
- Descendant · 3 generations on · 34 of its ownK150753 OASYS SystemStryker Corporation · 2015
- Descendant · 4 generations on · 33 of its ownK151755 OASYS (r) SystemStryker Corporation · 2015
Show all 9 generations
- Root · 9 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 8 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 7 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 6 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 5 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 4 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 3 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 2 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 1 generation backK072568 Modification to Oasys SystemStryker Spine · 2007
- This deviceK080143 Modification to Stryker Spine Oasys SystemStryker Spine · 2008
Showing 5 of 43 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 43 · See all- K093670Modification to: Oasys SystemStryker Spine · 2010 · cites it directly41descendants
- K111719Oasys Spinal SystemStryker Spine · 2012 · cites it directly39descendants
- K142741OASYS SystemStryker Corporation · 2015 · 2 generations on37descendants
- K150753OASYS SystemStryker Corporation · 2015 · 3 generations on34descendants
- K151755OASYS (r) SystemStryker Corporation · 2015 · 4 generations on33descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −8 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −7 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −6 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −5 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −4 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −3 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −2 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −1 | K072568 | Modification to Oasys System | Stryker Spine | 2007 | — |
| 0 (this device) | 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 | — |
| +3 | K150753 | OASYS System | Stryker Corporation | 2015 | — |
| +4 | K151755 | OASYS (r) System | Stryker Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 1 |
| 2012 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 7 | 0 |
| 2024 | 5 | 0 |
| 2025 | 1 | 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? (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 | Decided |
|---|---|---|---|
| * | K032394 | Stryker Spine Oasys SystemSummary page 1…[email protected] Date Summary Prepared: January 1, 2008 Predicate Device Identification Stryker Spine OASYS® System: K032394, K052317, K062853, K072568 Predicate Device Descripti… | 2004 |
| * | K052317 | Modification to: Stryker Spine Oasys SystemSummary page 1…[email protected] Date Summary Prepared: January 1, 2008 Predicate Device Identification Stryker Spine OASYS® System: K032394, K052317, K062853, K072568 Predicate Device Description The St… | 2005 |
| * | K062853 | Modification to Stryker Spine Oasys SystemSummary page 1…8 Predicate Device Identification Stryker Spine OASYS® System: K032394, K052317, K062853, K072568 Predicate Device Description The Stryker Spine OASYS' System is comprised of rods, polyaxial screws, bone screws, hooks… | 2006 |
| * | K072568 | Modification to Oasys SystemSummary page 1…ate Device Identification Stryker Spine OASYS® System: K032394, K052317, K062853, K072568 Predicate Device Description The Stryker Spine OASYS' System is comprised of rods, polyaxial screws, bone screws, hooks, connect… | 2007 |
What descends from it? (43)
See all 435 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 23 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K093670 (Stryker Spine, 2010) has gone furthest, with 41 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. 2008, this device’s year, is highlighted.
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 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 (180 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® 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/K080143 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080143: Modification to Stryker Spine Oasys System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080143
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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