510(k) Report

510(k) · Cleared

Cleared

Modification to: Oasys System

K101183510(k) SpecialCleared Nov 9, 2010195-day reviewClass II21 CFR 888.3050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Stryker Spine · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Nov 9, 2010 as substantially equivalent to K032394 (Howmedica Osteonics Corp., 2004) and 5 other predicates after a 195-day review. Its family tree reaches back 11 generations to 1985. 1 of the 21 devices in its family, counting itself, has a Class I recall.

Decided
Nov 9, 2010
Review
195 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
6

Its longest line of descent runs back 11 generations to K853033 (1985). 20 ancestors in all. No later device cites it as a predicate yet. 1 of the 21 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 2006: 1 other ancestor2005: 1 other ancestor2004: 1 other ancestor2001: 1 other ancestor2000: 1 other ancestor1999: 4 other ancestorsK853033 · Hartshill Rect & Wires, Spinal Fixation System · A.W. Showell (Surgicraft), Ltd. · 1985K965221 · Ransford Cervical Fixation System · Surgicraft, Ltd. · 1997K982322 · Synthes Spine Occipital-Cervical Plate/Rod and Hook System · Synthes (Usa) · 1998K002733 · Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2000K013222 · Summit Occipito-Cervico- Thoracic (Oct) Spinal System · Depuyacromed · 2001K022190 · Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2002K030103 · Summit Oct Spinal System Minipolyaxial Screws · Depuyacromed · 2003K041203 · Summit Oct Spinal System · Depuy Spine, Inc. · 2004K072568 · Modification to Oasys System · Stryker Spine · 2007K080143 · Modification to Stryker Spine Oasys System · Stryker Spine · 2008K093670 · Modification to: Oasys System · Stryker Spine · 2010 · Class I recall198519901995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors3 generations back: 1 other ancestor4 generations back: 5 other ancestors K093670 · Modification to: Oasys System · Stryker Spine · 2010 · Class I recallK080143 · Modification to Stryker Spine Oasys System · Stryker Spine · 2008K072568 · Modification to Oasys System · Stryker Spine · 2007K041203 · Summit Oct Spinal System · Depuy Spine, Inc. · 2004K030103 · Summit Oct Spinal System Minipolyaxial Screws · Depuyacromed · 2003K022190 · Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2002K013222 · Summit Occipito-Cervico- Thoracic (Oct) Spinal System · Depuyacromed · 2001K002733 · Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2000K982322 · Synthes Spine Occipital-Cervical Plate/Rod and Hook System · Synthes (Usa) · 1998K965221 · Ransford Cervical Fixation System · Surgicraft, Ltd. · 1997K853033 · Hartshill Rect & Wires, Spinal Fixation System · A.W. Showell (Surgicraft), Ltd. · 1985−10−50
  1. Root · 11 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 7 generations between
  3. 3 generations backK072568 Modification to Oasys SystemStryker Spine · 2007
  4. 2 generations backK080143 Modification to Stryker Spine Oasys SystemStryker Spine · 2008
  5. 1 generation backK093670 Modification to: Oasys SystemStryker Spine · 2010 · Recalled (Class I)
  6. This deviceK101183 Modification to: Oasys SystemStryker Spine · 2010
Show all 11 generations
  1. Root · 11 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 10 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
  3. 9 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
  4. 8 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
  5. 7 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
  6. 6 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
  7. 5 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
  8. 4 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
  9. 3 generations backK072568 Modification to Oasys SystemStryker Spine · 2007
  10. 2 generations backK080143 Modification to Stryker Spine Oasys SystemStryker Spine · 2008
  11. 1 generation backK093670 Modification to: Oasys SystemStryker Spine · 2010 · Recalled (Class I)
  12. This deviceK101183 Modification to: Oasys SystemStryker Spine · 2010

Class I recalls in this family

  • K093670 Modification to: Oasys Systemdirect predicate · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K853033Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd.1985—
−10K965221Ransford Cervical Fixation SystemSurgicraft, Ltd.1997—
−9K982322Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa)1998—
−8K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2000—
−7K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed2001—
−6K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2002—
−5K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed2003—
−4K041203Summit Oct Spinal SystemDepuy Spine, Inc.2004—
−3K072568Modification to Oasys SystemStryker Spine2007—
−2K080143Modification to Stryker Spine Oasys SystemStryker Spine2008—
−1K093670Modification to: Oasys SystemStryker Spine2010Class I
0 (this device)K101183Modification to: Oasys SystemStryker Spine2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199940
200010
200110
200410
200510
200610
FIG. 1 — Lineage of K101183, 1985–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K032394Stryker Spine Oasys System
Summary page 1
…Truesdale~Styker.com Date Summary Prepared: November 4, 201 0 Predicate Device Identification Stryker Spine GASYS® System: K032394, K0523 17, K062853, K072568. K080143, K093670 Predicate Device Descr…
Howmedica Osteonics Corp.2004—
*K052317Modification to: Stryker Spine Oasys System
Summary page 1
…~Styker.com Date Summary Prepared: November 4, 201 0 Predicate Device Identification Stryker Spine GASYS® System: K032394, K0523 17, K062853, K072568. K080143, K093670 Predicate Device Descriptio The…
Stryker Spine2005—
*K062853Modification to Stryker Spine Oasys System
Summary page 1
…4, 201 0 Predicate Device Identification Stryker Spine GASYS® System: K032394, K0523 17, K062853, K072568. K080143, K093670 Predicate Device Descriptio The Stryker Spine OASYS® System is comprised of rods, polyaxial screws, bo…
Stryker Spine2006—
*K072568Modification to Oasys System
Summary page 1
…Predicate Device Identification Stryker Spine GASYS® System: K032394, K0523 17, K062853, K072568. K080143, K093670 Predicate Device Descriptio The Stryker Spine OASYS® System is comprised of rods, polyaxial screws, bone screws…
Stryker Spine2007—
*K080143Modification to Stryker Spine Oasys System
Summary page 1
…icate Device Identification Stryker Spine GASYS® System: K032394, K0523 17, K062853, K072568. K080143, K093670 Predicate Device Descriptio The Stryker Spine OASYS® System is comprised of rods, polyaxial screws, bone screws, hooks,…
Stryker Spine2008—
*K093670Modification to: Oasys System
Summary page 1
…ice Identification Stryker Spine GASYS® System: K032394, K0523 17, K062853, K072568. K080143, K093670 Predicate Device Descriptio The Stryker Spine OASYS® System is comprised of rods, polyaxial screws, bone screws, hooks, connector…
Stryker Spine2010Class I

Also cleared against K032394: 13 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 25 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.
  • 13 other devices also cite its predicate K032394.

How does its category compare?

All KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · KWP

9in 2015

2007: 142008: 132009: 122010: 142011: 122012: 182013: 122014: 132015: 9
2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007: 96 days median2008: 50 days median2009: 89 days median2010: 186 days median2011: 67 days median2012: 112 days median2013: 99 days median2014: 138 days median2015: 113 days median
2007high 186 (2010) · low 50 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KWP

2in 2022

2007: 22008: 12009: 232010: 22011: 62012: 12013: 32015: 12016: 32018: 12019: 22022: 2
2007high 23 (2009) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWP

494in 2025

2007: 2102008: 5942009: 6822010: 4742011: 7922012: 9182013: 1,0902014: 1,0222015: 1,3482016: 1,3792017: 8642018: 6572019: 5182020: 7962021: 5252022: 3352023: 3322024: 4362025: 494
2007high 1,379 (2016) · low 210 (2007)2025

MAUDE reports naming product code KWP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200714962210
200813501594
2009128923682
2010141862474
201112676792
2012181121918
2013129931,090
20141313801,022
2015911311,348
20160—31,379
20170—0864
20180—1657
20190—2518
20200—0796
20210—0525
20220—2335
20230—0332
20240—0436
20250—0494
20260—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 (199 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 also be linked to the Xia® System, SR90D System and Xia® 4.5 Spinal System.

The Stryker Spine OASYS® System can also be linked to the Xia® System, SR90D System and Xia® 4.5 System via the rod-to-rod connectors and polyaxial screws of Xia® 1 and Xia® 3 Systems via the saddle connector.

Indications for use as stated in the FDA summary.

Also cleared against K032394

13 other devices cite the same predicate.

  • K193129Yukon OCT Spinal SystemK2m, Inc. · 20201 recall
  • K111719Oasys Spinal SystemStryker Spine · 2012
  • K093670Modification to: Oasys SystemStryker Spine · 20101 Class I recall
  • K092295Pioneer Posterior Cervico-Thoracic SystemPioneer Surgical Technology · 2010
  • K091359Gso PCT Spinal SystemGold Standard Orthopaedics, LLC · 2009
  • K090343Sentinel Spinal SystemLife Spine · 2009

More from Stryker Spine

92 FDA decisions under this applicant name. See the company

  • K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero®…Stryker Spine · 2026
  • K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute…Stryker Spine · 2026
  • K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System…Stryker Spine · 2024
  • K242280Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute…Stryker Spine · 2024
  • K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA®…Stryker Spine · 2023

Recent decisions in KWP

The KWP category page

  • K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2015
  • K150753OASYS SystemStryker Corporation · 2015
  • K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc. · 2015
  • K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
  • K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 20153 recalls

https://510kreport.com/device/K101183 · printed Nov 3, 2026

Cite this page

510(k) Report. “K101183: Modification to: Oasys System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K101183

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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