510(k) Report

510(k) · Cleared

Cleared

Gso PCT Spinal System

K091359510(k) TraditionalCleared Sep 2, 2009117-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

Gold Standard Orthopaedics, LLC · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Sep 2, 2009 as substantially equivalent to K080828 (Depuy Spine, Inc., 2008) and 4 other predicates after a 117-day review. Its family tree reaches back 10 generations to 1985.

Decided
Sep 2, 2009
Review
117 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
5

Its longest line of descent runs back 10 generations to K853033 (1985). 25 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2008: 1 other ancestor2007: 1 other ancestor2004: 3 other ancestors2006: 1 other ancestor2005: 1 other ancestor2003: 1 other ancestor2001: 2 other ancestors2000: 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 · 2008198519901995200020052010
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 6 other ancestors3 generations back: 5 other ancestors K080143 · 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 · 10 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 6 generations between
  3. 3 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
  4. 2 generations backK072568 Modification to Oasys SystemStryker Spine · 2007
  5. 1 generation backK080143 Modification to Stryker Spine Oasys SystemStryker Spine · 2008
  6. This deviceK091359 Gso PCT Spinal SystemGold Standard Orthopaedics, LLC · 2009
Show all 10 generations
  1. Root · 10 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 9 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
  3. 8 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
  4. 7 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
  5. 6 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
  6. 5 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
  7. 4 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
  8. 3 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
  9. 2 generations backK072568 Modification to Oasys SystemStryker Spine · 2007
  10. 1 generation backK080143 Modification to Stryker Spine Oasys SystemStryker Spine · 2008
  11. This deviceK091359 Gso PCT Spinal SystemGold Standard Orthopaedics, LLC · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K853033Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd.1985—
−9K965221Ransford Cervical Fixation SystemSurgicraft, Ltd.1997—
−8K982322Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa)1998—
−7K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2000—
−6K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed2001—
−5K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2002—
−4K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed2003—
−3K041203Summit Oct Spinal SystemDepuy Spine, Inc.2004—
−2K072568Modification to Oasys SystemStryker Spine2007—
−1K080143Modification to Stryker Spine Oasys SystemStryker Spine2008—
0 (this device)K091359Gso PCT Spinal SystemGold Standard Orthopaedics, LLC2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199940
200010
200120
200310
200430
200510
200610
200710
200810
FIG. 1 — Lineage of K091359, 1985–2009Source: 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.

Planning a device in KWP? 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K080828Mountaineer Oct Spinal System
Summary page 2
…PCT Spinal System has a similar indications and design and is manufactured from the same materials as the Mountaineer OCT Spinal System - Depuy Spine, Inc. (1K080828), the Altius OCT System - Interpore Cross International (1K033961), and the OASYS System - Stryker Spine (K(080143, K…
Depuy Spine, Inc.2008—
*K033961Altius Oct System
Summary page 2
…factured from the same materials as the Mountaineer OCT Spinal System - Depuy Spine, Inc. (1K080828), the Altius OCT System - Interpore Cross International (1K033961), and the OASYS System - Stryker Spine (K(080143, K032394) 11. Non-Clinical Testing- Mechanical testing conducted…
Interpore Cross Intl.2004—
*K080143Modification to Stryker Spine Oasys System
Summary page 1
…Mountaineer OCT Spinal System - Depuy Spine, Inc. (1080828) * Altius OCT System - Interpore Cross International (K(033961) * OASYS System - Stryker Spine (1K080143, K032394) * GS1 Spinal System - Gold Standard Orthopaedics, LLC (1K070966) 7. Device Description: The GSO PCT Spi…
Stryker Spine2008—
*K032394Stryker Spine Oasys System
Summary page 1
…er OCT Spinal System - Depuy Spine, Inc. (1080828) * Altius OCT System - Interpore Cross International (K(033961) * OASYS System - Stryker Spine (1K080143, K032394) * GS1 Spinal System - Gold Standard Orthopaedics, LLC (1K070966) 7. Device Description: The GSO PCT Spinal Syste…
Howmedica Osteonics Corp.2004—
*K070966Gso GS1 Spinal System
Summary page 1
…ystem - Interpore Cross International (K(033961) * OASYS System - Stryker Spine (1K080143, K032394) * GS1 Spinal System - Gold Standard Orthopaedics, LLC (1K070966) 7. Device Description: The GSO PCT Spinal System consists of rods, screws, hooks, and connecting components that c…
Gold Standard Orthopaedics, LLC2007—

Also cleared against K080828: 7 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 24 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
  • None of the 25 ancestors has a recall.
  • 7 other devices also cite its predicate K080828.

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. 2009, 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?

The GSO PCT Spinal System is intended to promote fusion of the cervical spine and cervico-thoracic junction (C1-T3), and is indicated for the following:

1. Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)

2. Spondylolisthesis

3. Spinal stenosis

4. Fracture or dislocation

5. Revision of previous cervical or cervico-throracic spine surgery

6. Tumors

The use of multi-axial pedicle screws is limited to placement in the upper thoracic spine (TI-T3) for the purpose of anchoring the construct. The multi-axial pedicle screws are not intended to be placed in the cervical spine.

Indications for use as stated in the FDA summary.

Also cleared against K080828

7 other devices cite the same predicate.

  • K181350ASTRA-OCT Spine SystemSpinecraft, LLC · 2018
  • K132332Mountaineer Oct Spinal SystemMedos International SARL · 2013
  • K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
  • K110353Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2011
  • K103100Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2010
  • K093319Nuvasive Vuepoint Oct SystemNuvasive, Inc. · 2010

More from Gold Standard Orthopaedics, LLC

4 FDA decisions under this applicant name. See the company

  • K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC · 2013
  • K070966Gso GS1 Spinal SystemGold Standard Orthopaedics, LLC · 2007
  • K063589Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC · 2007

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/K091359 · printed Nov 5, 2026

Cite this page

510(k) Report. “K091359: Gso PCT Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091359

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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