510(k) Report

510(k) · Cleared

Cleared

Marauder Cervical-Thoracic Spinal Fixation System

K132900510(k) TraditionalCleared Oct 25, 201339-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

Intelligent Implant Systems, LLC · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Oct 25, 2013 as substantially equivalent to K050979 (Aesculap, Inc., 2005) and 2 other predicates after a 39-day review. Its family tree reaches back 9 generations to 1985.

Decided
Oct 25, 2013
Review
39 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
3

Its longest line of descent runs back 9 generations to K853033 (1985). 24 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2008: 1 other ancestor2007: 1 other ancestor2004: 2 other ancestors2003: 2 other ancestors2002: 2 other ancestors2001: 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. · 2004K050979 · S4 Spinal System · Aesculap, Inc. · 20051985199019952000200520102015
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 5 other ancestors3 generations back: 4 other ancestors4 generations back: 4 other ancestors K050979 · S4 Spinal System · Aesculap, Inc. · 2005K041203 · 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. · 1985−50
  1. Root · 9 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 5 generations between
  3. 3 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
  4. 2 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
  5. 1 generation backK050979 S4 Spinal SystemAesculap, Inc. · 2005
  6. This deviceK132900 Marauder Cervical-Thoracic Spinal Fixation SystemIntelligent Implant Systems, LLC · 2013
Show all 9 generations
  1. Root · 9 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 8 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
  3. 7 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
  4. 6 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
  5. 5 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
  6. 4 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
  7. 3 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
  8. 2 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
  9. 1 generation backK050979 S4 Spinal SystemAesculap, Inc. · 2005
  10. This deviceK132900 Marauder Cervical-Thoracic Spinal Fixation SystemIntelligent Implant Systems, LLC · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K853033Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd.1985—
−8K965221Ransford Cervical Fixation SystemSurgicraft, Ltd.1997—
−7K982322Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa)1998—
−6K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2000—
−5K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed2001—
−4K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2002—
−3K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed2003—
−2K041203Summit Oct Spinal SystemDepuy Spine, Inc.2004—
−1K050979S4 Spinal SystemAesculap, Inc.2005—
0 (this device)K132900Marauder Cervical-Thoracic Spinal Fixation SystemIntelligent Implant Systems, LLC2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199940
200010
200120
200220
200320
200420
200710
200810
FIG. 1 — Lineage of K132900, 1985–2013Source: 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? (3)

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
*K050979S4 Spinal System
Summary page 1
…nal Interlaminal Fixation Orthosis Device Class: I Device Product Code: MNI, KWP Predicate Devices: Aesculap: S4® Spinal Fixation System (K050979) K2M. Inc.: MESA® Mini Spinal F-ixation System (K(081107)…
Aesculap, Inc.2005—
*K081107Caspian Spinal System, Screws, Rods, Hooks, Rod Connectors
Summary page 1
…te Devices: Aesculap: S4® Spinal Fixation System (K050979) K2M. Inc.: MESA® Mini Spinal F-ixation System (K(081107) Synthes. Inc.: Synapse System (K(070573)…
K2m, Inc.2008—
*K070573Synapse System
Summary page 1
…K2M. Inc.: MESA® Mini Spinal F-ixation System (K(081107) Synthes. Inc.: Synapse System (K(070573) * K132900…
Synthes Spine Co.Lp2007—

Also cleared against K050979: 11 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 28 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
  • 1 of the 24 ancestors has a recall of any class.
  • 11 other devices also cite its predicate K050979.

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. 2013, 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 MarauderTM Cervical-Thoracic Spinal Fixation System is intended to promote fusion of the cervical and thoracic spine (C] -T3) for the following conditions: degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; spinal stenosis; trauma (fracture/dislocation); failed previous fusion; and/or tumors. The hooks and rods are also intended to…

Read the full statement (105 words)

The MarauderTM Cervical-Thoracic Spinal Fixation System is intended to promote fusion of the cervical and thoracic spine (C] -T3) for the following conditions: degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; spinal stenosis; trauma (fracture/dislocation); failed previous fusion; and/or tumors.

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 (CI-T3) spine.

The use of screws is limited to placement in TI-T3 for treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.

Indications for use as stated in the FDA summary.

Also cleared against K050979

11 other devices cite the same predicate.

  • K173180Mega Plus Spine SystemBk Meditech, Co., Ltd. · 2018
  • K162300Reform® POCT SystemPrecision Spine, Inc. · 2016
  • K160722CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine · 2016
  • K133214Blackbird Spinal SystemChoicespine, LP · 2014
  • K122163Certex Spinal Implant SystemX-Spine Systems, Inc. · 2012
  • K121136Renoir Posterior Cervial Fixation SystemAccel Spine · 2012

More from Intelligent Implant Systems, LLC

6 FDA decisions under this applicant name. See the company

  • K173935Mediant Anterior Cervical Plating SystemIntelligent Implant Systems, LLC · 2018
  • K163056Revolution™ Spinal Fixation SystemIntelligent Implant Systems, LLC · 2017
  • K160216Revolution Spinal Fixation SystemIntelligent Implant Systems, LLC · 2016
  • K142939Revolution Spinal Fixation SystemIntelligent Implant Systems, LLC · 2015
  • K121682Active Screw Bone ScrewIntelligent Implant Systems, LLC · 2012

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/K132900 · printed Nov 5, 2026

Cite this page

510(k) Report. “K132900: Marauder Cervical-Thoracic Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132900

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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