510(k) Report

510(k) · Cleared

Recalled · 2011

4.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S or N

K043351510(k) TraditionalCleared Feb 18, 200574-day reviewClass URecalls 1

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

Triage Medical, Inc. · MRW System, Facet Screw Spinal Device

Cleared on Feb 18, 2005 as substantially equivalent to K020411 (Nuvasive, Inc., 2002) after a 74-day review. Its family tree reaches back 1 generation to 2002. 11 later devices descend from it. It has been recalled once.

Decided
Feb 18, 2005
Review
74 days
Class
Class U
Product code
MRW
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K020411 (2002). 11 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2005: 1 descendant cleared2008: 1 descendant cleared2010: 2 descendants cleared2009: 1 descendant cleared2011: 1 descendant cleared2024: 2 descendants cleared2019: 1 descendant cleared2025: 1 descendant clearedK020411 · Nuvasive Triad Facet Screw System · Nuvasive, Inc. · 2002200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 3 descendants4 generations forward: 3 descendants K020411 · Nuvasive Triad Facet Screw System · Nuvasive, Inc. · 20020
  1. Root · 1 generation backK020411 Nuvasive Triad Facet Screw SystemNuvasive, Inc. · 2002
  2. This deviceK043351 4.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S…Triage Medical, Inc. · 2005
  3. Descendant · cites it directly · 9 of its ownK062391 Disposable Posterior Lumbar Stabilization Procedure Kit, Models…Triage Medical, Inc. · 2006 · Recalled
  4. Descendant · cites it directly · 8 of its ownK082795 Single Use Perpos PLS System, 4.5 Bone-Lok PLS ImplantInterventional Spine, Inc. · 2008
  5. Descendant · 2 generations on · 4 of its ownK102438 Primalok Facet Fixation SystemOsteomed LP · 2010 · Recalled
  6. Descendant · 2 generations on · 3 of its ownK090767 Perpos FCD-2 System (Single Patient Use), Anchor, StabilizerInterventional Spine, Inc. · 2009
  7. Descendant · 3 generations on · 2 of its ownK240085 zLOCK Lumbar Facet Fixation SystemZygofix, Ltd. · 2024

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12008: 12009: 12010: 22011: 12019: 12024: 22025: 1
2005high 2 (2010) · low 0 (2007)2026

Most influential descendants

Showing 5 of 11 · See all
  • K062391Disposable Posterior Lumbar Stabilization Procedure Kit, Models 9045-01 and 9045-02…Triage Medical, Inc. · 2006 · cites it directly9descendants
  • K082795Single Use Perpos PLS System, 4.5 Bone-Lok PLS ImplantInterventional Spine, Inc. · 2008 · cites it directly8descendants
  • K102438Primalok Facet Fixation SystemOsteomed LP · 2010 · 2 generations on4descendants
  • K090767Perpos FCD-2 System (Single Patient Use), Anchor, StabilizerInterventional Spine, Inc. · 2009 · 2 generations on3descendants
  • K240085zLOCK Lumbar Facet Fixation SystemZygofix, Ltd. · 2024 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K020411Nuvasive Triad Facet Screw SystemNuvasive, Inc.2002—
0 (this device)K0433514.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S or NTriage Medical, Inc.2005—
+1K062391Disposable Posterior Lumbar Stabilization Procedure Kit, Models 9045-01 and…Triage Medical, Inc.20061
+1K082795Single Use Perpos PLS System, 4.5 Bone-Lok PLS ImplantInterventional Spine, Inc.2008—
+2K102438Primalok Facet Fixation SystemOsteomed LP20101
+2K090767Perpos FCD-2 System (Single Patient Use), Anchor, StabilizerInterventional Spine, Inc.2009—
+3K240085zLOCK Lumbar Facet Fixation SystemZygofix, Ltd.2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200810
200910
201020
201110
201910
202420
202510
FIG. 1 — Lineage of K043351, 2002–2025Source: 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? (1)

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
*K020411Nuvasive Triad Facet Screw System
Summary page 1
…CATE DEVICE The 4.5mm BONE-LOK®e Facet Screw is similar in basic design, materials and intended use to the NuVasive'Tm Triadt m Fac-et Screw System cleared under 51 0(k) K02041 1. DEVICE DESCRIPTION The 4.5mm BONE-LOK® Facet Screw is a double-helix screw with a compression- locking collar and a self-retai…
Nuvasive, Inc.2002—

Also cleared against K020411: 10 other devices →

What descends from it? (11)

See all 11

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K062391Disposable Posterior Lumbar Stabilization Procedure Kit, Models 9045-01 and 9045-02…Triage Medical, Inc.20069
K082795Single Use Perpos PLS System, 4.5 Bone-Lok PLS ImplantInterventional Spine, Inc.20088
K0519494.5 MM LS Facet Compression Device with Polymer Washer, Model LSPW-45-3040Triage Medical, Inc.20050

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

Recalls of this device

DateClassRecallRoot causeReason
Mar 15, 2011Not classifiedZ-3034-2011OtherThis recall has been initiated due to Pull Pins that may disengage from the Facet Screw during the compression step, requiring that compression be completed with a device driver rather than the compression tool. Use of this product may…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K062391 (Triage Medical, Inc., 2006) has gone furthest, with 9 descendants of its own.
  • 10 other devices also cite its predicate K020411.

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.

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 4.5mm BONE-LOK® Facet Screw is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis or failed previous fusion. The intended use of the 4.5mm BONE-LOK® Facet Screw is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The…

Read the full statement (111 words)

The 4.5mm BONE-LOK® Facet Screw is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis or failed previous fusion.

The intended use of the 4.5mm BONE-LOK® Facet Screw is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint and into the pedicle. The 4.5mm BONE-LOK® Facet Screw is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to S1.

Indications for use as stated in the FDA summary.

Also cleared against K020411

10 other devices cite the same predicate.

  • K183589PMT Facet ScrewProvidence Medical Technology, Inc. · 2019
  • K173198Facet Screw Fixation SystemU&I Corporation · 2018
  • K113011Spartan S3 Facet SystemAmendia, Inc. · 2011
  • K101762Viper F2 Facet Fixation SystemDepuy Spine, Inc. · 2010
  • K101364Lanx Facet Screw SystemLanx, Inc. · 2010
  • K101284Facet Screw SystemNuvasive, Inc. · 2010

More from Triage Medical, Inc.

11 FDA decisions under this applicant name. See the company

  • K062391Disposable Posterior Lumbar Stabilization Procedure Kit, Models 9045-01 and 9045-02; Compression Tool, Model…Triage Medical, Inc. · 20061 recall
  • K0520433.8MM CS Facet Compression DeviceTriage Medical, Inc. · 2005
  • K0519494.5 MM LS Facet Compression Device with Polymer Washer, Model LSPW-45-3040Triage Medical, Inc. · 2005
  • K042244Bone-Lok MVP Cortical-Cancellous Compression DeviceTriage Medical, Inc. · 2004
  • K040250Bone-Lok HP WasherTriage Medical, Inc. · 2004

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/K043351 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043351: 4.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S or N.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043351

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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