510(k) Report

510(k) · Cleared

Cleared

Gibralt Spine Systems Facet Screw 04.0,04.5

K112097510(k) TraditionalCleared Nov 21, 2011122-day reviewClass U

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

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

Cleared on Nov 21, 2011 as substantially equivalent to K073515 (Trans1 Incorporated, 2008) and 4 other predicates after a 122-day review. Its family tree reaches back 4 generations to 1997.

Decided
Nov 21, 2011
Review
122 days
Class
Class U
Product code
MRW
Recalls
None
Predicates
6

Its longest line of descent runs back 4 generations to K953076 (1997). 12 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2009: 1 other ancestor2008: 1 other ancestor2006: 1 other ancestor2003: 1 other ancestor2002: 1 other ancestor2001: 2 other ancestors2000: 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: 3 other ancestors2 generations back: 5 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 deviceK112097 Gibralt Spine Systems Facet Screw 04.0,04.5Exactech, 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)K112097Gibralt Spine Systems Facet Screw 04.0,04.5Exactech, Inc.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200120
200210
200310
200610
200810
200910
FIG. 1 — Lineage of K112097, 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K073515TRANS1 Facet Screw
Summary page 1
…sification Name: Unclassified Product Code: MRW Legally Marketed Devices to Which Substantial Equivalence Is Claimed * TranS I Facet Screw (K0735 15) * Spartan S3 Facet System (K092568) " Corridor Fixation System (K083442) * US Spine Facet Fixation System (K06 1041)…
Trans1 Incorporated2008—
*K092568Spartan S3 Facet System
Summary page 1
…Product Code: MRW Legally Marketed Devices to Which Substantial Equivalence Is Claimed * TranS I Facet Screw (K0735 15) * Spartan S3 Facet System (K092568) " Corridor Fixation System (K083442) * US Spine Facet Fixation System (K06 1041) * DePuy AcroMed Discovery Facet Screw…
Amendia, Inc.2009—
*K083442Corridor Fixation System
Summary page 1
…ly Marketed Devices to Which Substantial Equivalence Is Claimed * TranS I Facet Screw (K0735 15) * Spartan S3 Facet System (K092568) " Corridor Fixation System (K083442) * US Spine Facet Fixation System (K06 1041) * DePuy AcroMed Discovery Facet Screw (KG 12773) * SpineFrontier Chameleon…
Globus Medical, Inc.2009—
*K061041US Spine Facet Fixation System
Summary page 1
…alence Is Claimed * TranS I Facet Screw (K0735 15) * Spartan S3 Facet System (K092568) " Corridor Fixation System (K083442) * US Spine Facet Fixation System (K06 1041) * DePuy AcroMed Discovery Facet Screw (KG 12773) * SpineFrontier Chameleon Fixation System (K07 1420) Device Description…
Us Spine2006—
Kept off the family treeK012773FDA’s K012773 is Discovery Facet Screw Fixation System
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
Depuyacromed2001—
*K071420Chameleon Fixation System
Summary page 1
…ixation System (K083442) * US Spine Facet Fixation System (K06 1041) * DePuy AcroMed Discovery Facet Screw (KG 12773) * SpineFrontier Chameleon Fixation System (K07 1420) Device Description The proposed Gibralt Spine System Facet Screw is a new facet screw device intended to provide posterior fixa…
Spinefrontier, Inc.20081

Also cleared against K073515: 10 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 4 companies; a new generation was cleared every 2.5 years on median.
  • 1 of the 12 ancestors has a recall of any class.
  • 10 other devices also cite its predicate K073515.

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 Gibrait Spine System Facet Screw is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spondylolysis, fracture, or failed previous fusion.

Indications for use as stated in the FDA summary.

Also cleared against K073515

10 other devices cite the same predicate.

  • K152137FacetBRIDGE SystemLdr Spine USA · 2016
  • K142980Proficient (TM) Facet Screw Spine SystemSpine Wave, Inc. · 2015
  • K132126Spectrum Spine Fenestrated Facet Screw SystemSpectrum Spine, LLC · 2013
  • K130863Facet Screw SystemSpinal USA · 2013
  • K120597KompredaCustom Spine, Inc. · 2013
  • K113011Spartan S3 Facet SystemAmendia, Inc. · 2011

More from Exactech, Inc.

207 FDA decisions under this applicant name. See the company

  • K260583Equinoxe® Shoulder SystemExactech, Inc. · 2026
  • K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc. · 2025
  • K243448Equinoxe® Shoulder SystemExactech, Inc. · 2025
  • K243275Equinoxe® Scapula Fracture SystemExactech, Inc. · 2025
  • K243839Alteon® HA Femoral StemsExactech, Inc. · 2025

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/K112097 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112097: Gibralt Spine Systems Facet Screw 04.0,04.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112097

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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