510(k) · Cleared
ClearedOASYS System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corporation · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Jun 9, 2015 as substantially equivalent to K142741 (Stryker Corporation, 2015) after a 78-day review. Its family tree reaches back 13 generations to 1985. 1 of the 57 devices in its family, counting itself, has a Class I recall. 34 later devices descend from it.
- Decided
- Jun 9, 2015
- Review
- 78 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K853033 (1985). 22 ancestors in all. 34 later devices descend from it, 1 citing it directly. 1 of the 57 devices in this family, counting this one, has a Class I recall.
- Root · 13 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 9 generations between
- 3 generations backK093670 Modification to: Oasys SystemStryker Spine · 2010 · Recalled (Class I)
- 2 generations backK111719 Oasys Spinal SystemStryker Spine · 2012
- 1 generation backK142741 OASYS SystemStryker Corporation · 2015
- This deviceK150753 OASYS SystemStryker Corporation · 2015
- Descendant · cites it directly · 33 of its ownK151755 OASYS (r) SystemStryker Corporation · 2015
- Descendant · 2 generations on · 17 of its ownK153370 Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated · 2016
- Descendant · 3 generations on · 13 of its ownK171444 YUKON OCT Spinal SystemK2m, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 12 of its ownK162136 CastleLoc-S Posterior Cervical Fixation System; LnK Posterior…L&K BIOMED Co., Ltd. · 2016
- Descendant · 3 generations on · 11 of its ownK200793 LnK Posterior Cervical Fixation System and CastleLoc-S Posterior…L&K BIOMED Co., Ltd. · 2020
Show all 13 generations
- Root · 13 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 12 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 11 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 10 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 9 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 8 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 7 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 6 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 5 generations backK072568 Modification to Oasys SystemStryker Spine · 2007
- 4 generations backK080143 Modification to Stryker Spine Oasys SystemStryker Spine · 2008
- 3 generations backK093670 Modification to: Oasys SystemStryker Spine · 2010 · Recalled (Class I)
- 2 generations backK111719 Oasys Spinal SystemStryker Spine · 2012
- 1 generation backK142741 OASYS SystemStryker Corporation · 2015
- This deviceK150753 OASYS SystemStryker Corporation · 2015
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K093670 Modification to: Oasys System3 generations back · 2010
Most influential descendants
Showing 5 of 34 · See all- K151755OASYS (r) SystemStryker Corporation · 2015 · cites it directly33descendants
- K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated · 2016 · 2 generations on17descendants
- K171444YUKON OCT Spinal SystemK2m, Inc. · 2017 · 3 generations on13descendants
- K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2016 · 2 generations on12descendants
- K200793LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2020 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −12 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −11 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −10 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −9 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −8 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −7 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −6 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −5 | K072568 | Modification to Oasys System | Stryker Spine | 2007 | — |
| −4 | K080143 | Modification to Stryker Spine Oasys System | Stryker Spine | 2008 | — |
| −3 | K093670 | Modification to: Oasys System | Stryker Spine | 2010 | Class I |
| −2 | K111719 | Oasys Spinal System | Stryker Spine | 2012 | — |
| −1 | K142741 | OASYS System | Stryker Corporation | 2015 | — |
| 0 (this device) | K150753 | OASYS System | Stryker Corporation | 2015 | — |
| +1 | K151755 | OASYS (r) System | Stryker Corporation | 2015 | — |
| +2 | K153370 | Caspian OCT/MESA Mini/DENALI Mini Spinal System | K2m, Incorporated | 2016 | — |
| +3 | K171444 | YUKON OCT Spinal System | K2m, Inc. | 2017 | 3 |
| +2 | K162136 | CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical… | L&K BIOMED Co., Ltd. | 2016 | — |
| +3 | K200793 | LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical… | L&K BIOMED Co., Ltd. | 2020 | — |
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 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 4 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K142741 | OASYS SystemSummary page 5…CFR § 888.3050 Codification Product Codes KWP Predicate Devices Primary Predicate: Stryker Spine OASYS® System: K142741 Device Description The Stryker Spine OASYS® System is comprised of rods, polyaxial screw… | 2015 |
What descends from it? (34)
See all 341 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151755 | OASYS (r) System | 2015 | 33 |
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 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 30 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 22 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K151755 (Stryker Corporation, 2015) has gone furthest, with 33 descendants of its own.
- 1 other device also cites its predicate K142741.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 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 (202 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 ). 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® 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® II and Xia® 3 System via the
saddle connector.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150753 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150753: 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/K150753
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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