510(k) Report

510(k) · Cleared

Cleared

Spartan S3 Facet System

K113011510(k) SpecialCleared Dec 6, 201156-day reviewClass U

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

Amendia, Inc. · MRW System, Facet Screw Spinal Device

Cleared on Dec 6, 2011 as substantially equivalent to K092568 (Amendia, Inc., 2009) and 5 other predicates after a 56-day review. Its family tree reaches back 4 generations to 1997.

Decided
Dec 6, 2011
Review
56 days
Class
Class U
Product code
MRW
Recalls
None
Predicates
6

Its longest line of descent runs back 4 generations to K953076 (1997). 11 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2010: 1 other ancestor2003: 1 other ancestor2002: 1 other ancestor2001: 2 other ancestors2009: 1 other ancestor2000: 1 other ancestorK953076 · Townley Facet/Pedicular Screw Plating System · Sofamor Danek USA,Inc. · 1997K051856 · TRANS1 Facet Screws · Trans1 Incorporated · 2005K073515 · TRANS1 Facet Screw · Trans1 Incorporated · 2008K092568 · Spartan S3 Facet System · Amendia, Inc. · 20091995200020052010
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 3 other ancestors K092568 · Spartan S3 Facet System · Amendia, Inc. · 2009K073515 · TRANS1 Facet Screw · Trans1 Incorporated · 2008K051856 · TRANS1 Facet Screws · Trans1 Incorporated · 2005K953076 · Townley Facet/Pedicular Screw Plating System · Sofamor Danek USA,Inc. · 19970
  1. Root · 4 generations backK953076 Townley Facet/Pedicular Screw Plating SystemSofamor Danek USA,Inc. · 1997
  2. 3 generations backK051856 TRANS1 Facet ScrewsTrans1 Incorporated · 2005
  3. 2 generations backK073515 TRANS1 Facet ScrewTrans1 Incorporated · 2008
  4. 1 generation backK092568 Spartan S3 Facet SystemAmendia, Inc. · 2009
  5. This deviceK113011 Spartan S3 Facet SystemAmendia, Inc. · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K953076Townley Facet/Pedicular Screw Plating SystemSofamor Danek USA,Inc.1997—
−3K051856TRANS1 Facet ScrewsTrans1 Incorporated2005—
−2K073515TRANS1 Facet ScrewTrans1 Incorporated2008—
−1K092568Spartan S3 Facet SystemAmendia, Inc.2009—
0 (this device)K113011Spartan S3 Facet SystemAmendia, Inc.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200120
200210
200310
200910
201010
FIG. 1 — Lineage of K113011, 1997–2011Source: 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 MRW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MRW device

  1. #1 K230840 PMT Facet Fixation System, Lumbar (PMT FFS-LX)score 26.0 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin 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
*K092568Spartan S3 Facet System
Summary page 1
…ns for use are the same for both systems. Predicate Device(s): The predicate devices previously cleared by FDA are the previously cleared Spartan S3 Facet Screw System (K092568), the Lanx Concero Facet Screw System (KIOI 364), DISCOVERY Facet Screw (K012773), Triad Facet Screw System (K02041 1), Oasys Bon…
Amendia, Inc.2009—
*K101364Lanx Facet Screw SystemLanx, Inc.2010—
*K012773Discovery Facet Screw Fixation System
Summary page 1
…ices previously cleared by FDA are the previously cleared Spartan S3 Facet Screw System (K092568), the Lanx Concero Facet Screw System (KIOI 364), DISCOVERY Facet Screw (K012773), Triad Facet Screw System (K02041 1), Oasys Bone Screw (K03 1657) and the Transi Facet Screw (K0735 15). Performance Testing: T…
Depuyacromed2001—
*K020411Nuvasive Triad Facet Screw System
Summary page 1
…he previously cleared Spartan S3 Facet Screw System (K092568), the Lanx Concero Facet Screw System (KIOI 364), DISCOVERY Facet Screw (K012773), Triad Facet Screw System (K02041 1), Oasys Bone Screw (K03 1657) and the Transi Facet Screw (K0735 15). Performance Testing: The pre-clinical testing was performed…
Nuvasive, Inc.2002—
*K031657Stryker Spine Oasys Bone Screw
Summary page 1
…S3 Facet Screw System (K092568), the Lanx Concero Facet Screw System (KIOI 364), DISCOVERY Facet Screw (K012773), Triad Facet Screw System (K02041 1), Oasys Bone Screw (K03 1657) and the Transi Facet Screw (K0735 15). Performance Testing: The pre-clinical testing was performed following ASTM F2 193-02. Te…
Howmedica Osteonics Corp.2003—
*K073515TRANS1 Facet Screw
Summary page 1
…Lanx Concero Facet Screw System (KIOI 364), DISCOVERY Facet Screw (K012773), Triad Facet Screw System (K02041 1), Oasys Bone Screw (K03 1657) and the Transi Facet Screw (K0735 15). Performance Testing: The pre-clinical testing was performed following ASTM F2 193-02. Testing consisted of static and dynamic…
Trans1 Incorporated2008—

Also cleared against K092568: 3 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 14 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
  • None of the 11 ancestors has a recall.
  • 3 other devices also cite its predicate K092568.

How does its category compare?

All MRW devices

MRW System, Facet Screw Spinal Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · MRW

7in 2025

2008: 32009: 62010: 62011: 32012: 42013: 72015: 22016: 22017: 12018: 22019: 32022: 32023: 32024: 72025: 72026 (partial year): 5
2007high 7 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MRW

97in 2025

2008: 88 days median2009: 89 days median2010: 108 days median2011: 122 days median2012: 119 days median2013: 110 days median2019: 90 days median2022: 252 days median2023: 190 days median2024: 50 days median2025: 97 days median2026 (partial year): 169 days median
2007high 252 (2022) · low 50 (2024)2026

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

Recalls per year · MRW

3in 2011

2011: 3
2007high 3 (2011) · low 0 (2007)2026

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

Adverse event reports per year · MRW

3in 2025

2007: 12009: 22010: 72011: 622012: 62013: 42014: 12015: 22016: 12017: 42018: 42021: 12023: 12024: 22025: 3
2007high 62 (2011) · low 0 (2008)2025

MAUDE reports naming product code MRW, 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
20070—01
200838800
200968902
2010610807
20113122362
2012411906
2013711004
20140—01
20152—02
20162—01
20171—04
20182—04
201939000
20200—00
20210—01
2022325200
2023319001
202475002
202579703
202651690—

What is it indicated for?

The Spartan S3 Facet System is indicated for the posterior surgical treatment of any or all of the following at the C2 to SI (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 4) Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or…

Read the full statement (112 words)

The Spartan S3 Facet System is indicated for the posterior surgical treatment of any or all of the following at the C2 to SI (inclusive) spinal levels:

1) Trauma, including spinal fractures and/or dislocations;

2) Spondylolisthesis;

3) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity;

4) Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.

The Spartan S3 Facet System will provide temporary stabilization as an adjunct to spinal fusion.

Indications for use as stated in the FDA summary.

Also cleared against K092568

3 other devices cite the same predicate.

  • K163374ALLY™ Facet ScrewsProvidence Medical Technology, Inc. · 2017
  • K120340Venus Facet Screw SystemApollo Spine, Inc. · 2012
  • K112097Gibralt Spine Systems Facet Screw 04.0,04.5Exactech, Inc. · 2011

More from Amendia, Inc.

16 FDA decisions under this applicant name. See the company

  • K160924Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
  • K161842Overwatch Spine SystemAmendia, Inc. · 20161 recall
  • K152920Savannah-T® Pedicle Screw SystemAmendia, Inc. · 20161 recall
  • K153152Syzygy Stabilization SystemAmendia, Inc. · 20162 recalls
  • K160291Optimus ALIF SystemAmendia, Inc. · 2016

Recent decisions in MRW

The MRW category page

  • K262618Arthrex Spine Compression FT ScrewArthrex, Inc. · 2026
  • K261209Ion-LSurGenTec, LLC · 2026
  • K253676CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)Providence Medical Technology, Inc. · 2026
  • K253432DiversiVy™ Facet Screw SystemVy Spine, LLC · 2026
  • K251714Ion-CSurGenTec, LLC · 2026

https://510kreport.com/device/K113011 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113011: Spartan S3 Facet System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113011

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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