510(k) · Cleared
Recalled · Class I · 2013Modification to: Oasys System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Spine · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Mar 18, 2010 as substantially equivalent to K032394 (Howmedica Osteonics Corp., 2004) and 4 other predicates after a 111-day review. Its family tree reaches back 10 generations to 1985. 1 of the 61 devices in its family, counting itself, has a Class I recall. 41 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Mar 18, 2010
- Review
- 111 days
- Class
- Class II
- Product code
- MNH
- Recalls
- 1 (1 Class I)
- Predicates
- 5
Its longest line of descent runs back 10 generations to K853033 (1985). 19 ancestors in all. 41 later devices descend from it, 2 citing it directly. 1 of the 61 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 6 generations between
- 3 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK072568 Modification to Oasys SystemStryker Spine · 2007
- 1 generation backK080143 Modification to Stryker Spine Oasys SystemStryker Spine · 2008
- This deviceK093670 Modification to: Oasys SystemStryker Spine · 2010
- 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
- Descendant · 5 generations on · 17 of its ownK153370 Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated · 2016
Show all 10 generations
- Root · 10 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 9 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 8 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 7 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 6 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 5 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 4 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 3 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK072568 Modification to Oasys SystemStryker Spine · 2007
- 1 generation backK080143 Modification to Stryker Spine Oasys SystemStryker Spine · 2008
- This deviceK093670 Modification to: Oasys SystemStryker Spine · 2010
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- 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
- K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated · 2016 · 5 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −9 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −8 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −7 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −6 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −5 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −4 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −3 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −2 | K072568 | Modification to Oasys System | Stryker Spine | 2007 | — |
| −1 | K080143 | Modification to Stryker Spine Oasys System | Stryker Spine | 2008 | — |
| 0 (this device) | K093670 | Modification to: Oasys System | Stryker Spine | 2010 | — |
| +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 | — |
| +5 | K153370 | Caspian OCT/MESA Mini/DENALI Mini Spinal System | K2m, Incorporated | 2016 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 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? (5)
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…E-Imail: Pauline. Shandc~Styker.com Date Summary Prepared: February 16, 201 0 Predicate Device Identificlitiol) Stryker Spine OASYS" Systemn: 1K032394, K05231 7. .K062853. K072568. and K080143 Predicate iDevice Description The Stryker Spine OASYSL" System is comprised ol rods, p… | 2004 |
| * | K052317 | Modification to: Stryker Spine Oasys SystemSummary page 1…Pauline. Shandc~Styker.com Date Summary Prepared: February 16, 201 0 Predicate Device Identificlitiol) Stryker Spine OASYS" Systemn: 1K032394, K05231 7. .K062853. K072568. and K080143 Predicate iDevice Description The Stryker Spine OASYSL" System is comprised ol rods, polyaxial s… | 2005 |
| * | K062853 | Modification to Stryker Spine Oasys SystemSummary page 1…handc~Styker.com Date Summary Prepared: February 16, 201 0 Predicate Device Identificlitiol) Stryker Spine OASYS" Systemn: 1K032394, K05231 7. .K062853. K072568. and K080143 Predicate iDevice Description The Stryker Spine OASYSL" System is comprised ol rods, polyaxial screws, bon… | 2006 |
| * | K072568 | Modification to Oasys SystemSummary page 1…ker.com Date Summary Prepared: February 16, 201 0 Predicate Device Identificlitiol) Stryker Spine OASYS" Systemn: 1K032394, K05231 7. .K062853. K072568. and K080143 Predicate iDevice Description The Stryker Spine OASYSL" System is comprised ol rods, polyaxial screws, bone screws,… | 2007 |
| * | K080143 | Modification to Stryker Spine Oasys SystemSummary page 1…e Summary Prepared: February 16, 201 0 Predicate Device Identificlitiol) Stryker Spine OASYS" Systemn: 1K032394, K05231 7. .K062853. K072568. and K080143 Predicate iDevice Description The Stryker Spine OASYSL" System is comprised ol rods, polyaxial screws, bone screws, hooks. conne… | 2008 |
What descends from it? (41)
See all 412 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 30, 2013 | Class I | Z-1976-2013 | Other | Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- None of the 19 ancestors has a recall.
- Of its descendants, K111719 (Stryker Spine, 2012) has gone furthest, with 39 descendants of its own.
- 13 other devices also cite its predicate K032394.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 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 Revision of previous…
Read the full statement (171 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/K093670 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093670: Modification to: 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/K093670
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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