510(k) · Cleared
ClearedOasys Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Spine · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Jan 19, 2012 as substantially equivalent to K032394 (Howmedica Osteonics Corp., 2004) and 5 other predicates after a 213-day review. Its family tree reaches back 11 generations to 1985. 1 of the 60 devices in its family, counting itself, has a Class I recall. 39 later devices descend from it.
- Decided
- Jan 19, 2012
- Review
- 213 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 11 generations to K853033 (1985). 20 ancestors in all. 39 later devices descend from it, 2 citing it directly. 1 of the 60 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 7 generations between
- 3 generations backK072568 Modification to Oasys SystemStryker Spine · 2007
- 2 generations backK080143 Modification to Stryker Spine Oasys SystemStryker Spine · 2008
- 1 generation backK093670 Modification to: Oasys SystemStryker Spine · 2010 · Recalled (Class I)
- This deviceK111719 Oasys Spinal SystemStryker Spine · 2012
- Descendant · cites it directly · 37 of its ownK142741 OASYS SystemStryker Corporation · 2015
- Descendant · 2 generations on · 34 of its ownK150753 OASYS SystemStryker Corporation · 2015
- Descendant · 3 generations on · 33 of its ownK151755 OASYS (r) SystemStryker Corporation · 2015
- Descendant · 4 generations on · 17 of its ownK153370 Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated · 2016
- Descendant · 5 generations on · 13 of its ownK171444 YUKON OCT Spinal SystemK2m, Inc. · 2017 · Recalled
Show all 11 generations
- Root · 11 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 10 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 9 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 8 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 7 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 6 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 5 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 4 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 3 generations backK072568 Modification to Oasys SystemStryker Spine · 2007
- 2 generations backK080143 Modification to Stryker Spine Oasys SystemStryker Spine · 2008
- 1 generation backK093670 Modification to: Oasys SystemStryker Spine · 2010 · Recalled (Class I)
- This deviceK111719 Oasys Spinal SystemStryker Spine · 2012
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K093670 Modification to: Oasys Systemdirect predicate · 2010
Most influential descendants
Showing 5 of 39 · See all- K142741OASYS SystemStryker Corporation · 2015 · cites it directly37descendants
- K150753OASYS SystemStryker Corporation · 2015 · 2 generations on34descendants
- K151755OASYS (r) SystemStryker Corporation · 2015 · 3 generations on33descendants
- K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated · 2016 · 4 generations on17descendants
- K171444YUKON OCT Spinal SystemK2m, Inc. · 2017 · 5 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −10 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −9 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −8 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −7 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −6 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −5 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −4 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −3 | K072568 | Modification to Oasys System | Stryker Spine | 2007 | — |
| −2 | K080143 | Modification to Stryker Spine Oasys System | Stryker Spine | 2008 | — |
| −1 | K093670 | Modification to: Oasys System | Stryker Spine | 2010 | Class I |
| 0 (this device) | K111719 | Oasys Spinal System | Stryker Spine | 2012 | — |
| +1 | K142741 | OASYS System | Stryker Corporation | 2015 | — |
| +2 | K150753 | OASYS System | Stryker Corporation | 2015 | — |
| +3 | K151755 | OASYS (r) System | Stryker Corporation | 2015 | — |
| +4 | K153370 | Caspian OCT/MESA Mini/DENALI Mini Spinal System | K2m, Incorporated | 2016 | — |
| +5 | K171444 | YUKON OCT Spinal System | K2m, Inc. | 2017 | 3 |
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 |
|---|---|---|
| 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? (7)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032394 | Stryker Spine Oasys System Our reading of the summary gave K032194, FDA’s number for Tigris DTS Automated Analyzer for Automating Amplified… (Gen-Probe, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Stryker Spine OASYS System”. | 2004 |
| * | K052317 | Modification to: Stryker Spine Oasys SystemSummary page 1…Email: [email protected] Date Summary Prepared: June 15, 2011 Predicate Device Identification Stryker Spine OASYS® System: K032194, K0523 17, K062853, K072568. K080143, K093670, KiI 183 Predicate Device Description The Stryker Sp… | 2005 |
| * | K062853 | Modification to Stryker Spine Oasys SystemSummary page 1…ared: June 15, 2011 Predicate Device Identification Stryker Spine OASYS® System: K032194, K0523 17, K062853, K072568. K080143, K093670, KiI 183 Predicate Device Description The Stryker Spine OASYSw System is comprised of rods, polyaxial… | 2006 |
| * | K072568 | Modification to Oasys SystemSummary page 1…June 15, 2011 Predicate Device Identification Stryker Spine OASYS® System: K032194, K0523 17, K062853, K072568. K080143, K093670, KiI 183 Predicate Device Description The Stryker Spine OASYSw System is comprised of rods, polyaxial screws,… | 2007 |
| * | K080143 | Modification to Stryker Spine Oasys SystemSummary page 1…June 15, 2011 Predicate Device Identification Stryker Spine OASYS® System: K032194, K0523 17, K062853, K072568. K080143, K093670, KiI 183 Predicate Device Description The Stryker Spine OASYSw System is comprised of rods, polyaxial screws, bone scre… | 2008 |
| * | K093670 | Modification to: Oasys SystemSummary page 1…une 15, 2011 Predicate Device Identification Stryker Spine OASYS® System: K032194, K0523 17, K062853, K072568. K080143, K093670, KiI 183 Predicate Device Description The Stryker Spine OASYSw System is comprised of rods, polyaxial screws, bone screws, hooks… | 2010 |
| Kept off the family tree | K111183 | FDA’s K111183 is Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2011 |
What descends from it? (39)
See all 392 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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 20 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K142741 (Stryker Corporation, 2015) has gone furthest, with 37 descendants of its own.
- 13 other devices also cite its predicate K032394.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 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 Gasys 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 * Atlanta/axial fracture with instability * Occipitocervical dislocation *…
Read the full statement (201 words)
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput-T3), the STRYKER Spine Gasys 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
* Atlanta/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). 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 (C I-T3) spine.
The Stryker Spine OASYS® System can be linked to the Xiag System, SR90D System and Xia® 4.5 Spinal System via the rod-to-rod connectors and transition rods.
The Stryker Spine OASYS® System can also be linked to the polyaxial screws of Xia® 11 and Xia®V 3 System via the saddle connector.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111719 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111719: Oasys Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111719
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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