510(k) Report

510(k) · Cleared

Cleared

CrossRoads Screw System

K143039510(k) TraditionalCleared Jan 16, 201586-day reviewClass II21 CFR 888.3040

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

Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem · HWC Screw, Fixation, Bone

Cleared on Jan 16, 2015 as substantially equivalent to K014154 (Vilex, Inc., 2002) and 8 other predicates after an 86-day review. Its family tree reaches back 10 generations to 1996. 1 of the 170 devices in its family, counting itself, has a Class I recall. 79 later devices descend from it.

Decided
Jan 16, 2015
Review
86 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
9

Its longest line of descent runs back 10 generations to K962616 (1996). 90 ancestors in all, the oldest K792022 (1979). 79 later devices descend from it, 3 citing it directly. 1 of the 170 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2014: 1 other ancestor2011: 1 other ancestor2010: 2 other ancestors2008: 4 other ancestors2002: 5 other ancestors1993: 2 other ancestors2009: 1 other ancestor2007: 1 other ancestor2006: 7 other ancestors2005: 7 other ancestors2003: 2 other ancestors2001: 7 other ancestors1998: 3 other ancestors1996: 7 other ancestors1995: 4 other ancestors2000: 7 other ancestors1999: 3 other ancestors1990: 1 other ancestor1989: 4 other ancestors1987: 1 other ancestor1979: 1 other ancestor2004: 4 other ancestors1994: 2 other ancestors1992: 1 other ancestor1981: 1 other ancestor1991: 1 other ancestor2017: 2 descendants cleared2019: 5 descendants cleared2015: 1 descendant cleared2016: 1 descendant cleared2022: 7 descendants cleared2021: 4 descendants cleared, 1 with a Class I recall12025: 15 descendants cleared2024: 15 descendants cleared2026: 19 descendants cleared2023: 9 descendants cleared2020: 1 descendant clearedK962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998×3: 3 generations cleared close together, K023007 (2002), K030198 (2003), K032705 (2003) ×2: 2 generations cleared close together, K050932 (2005), K051735 (2005) K071563 · Peri-Loc Periarticular Locked Plating System · Smith & Nephew, Inc. · 2007K090675 · Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories · Smith & Nephew, Inc. · 2009K111994 · Smith & Nephew Cannulated Screws and Washers · Smith & Nephew, Inc. · 201119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 22 other ancestors3 generations back: 20 other ancestors4 generations back: 19 other ancestors5 generations back: 6 other ancestors6 generations back: 2 other ancestors7 generations back: 2 other ancestors8 generations back: 1 other ancestor9 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 5 descendants3 generations forward: 30 descendants, 1 with a Class I recall14 generations forward: 14 descendants5 generations forward: 13 descendants6 generations forward: 9 descendants7 generations forward: 3 descendants8 generations forward: 1 descendant9 generations forward: 1 descendant K111994 · Smith & Nephew Cannulated Screws and Washers · Smith & Nephew, Inc. · 2011K090675 · Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories · Smith & Nephew, Inc. · 2009K071563 · Peri-Loc Periarticular Locked Plating System · Smith & Nephew, Inc. · 2007K051735 · Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity · Smith & Nephew, Inc. · 2005K050932 · Distal Volar Radius Anatomical Plate System · Hand Innovations, Inc. · 2005 · recalledK032705 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K030198 · Hand Innovations, Inc. Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K023007 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2002K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998K962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996−10−50+5
  1. Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 6 generations between
  3. 3 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
  4. 2 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  5. 1 generation backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
  6. This deviceK143039 CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
  7. Descendant · cites it directly · 74 of its ownK162825 CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017
  8. Descendant · 2 generations on · 69 of its ownK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
  9. Descendant · 3 generations on · 42 of its ownK191100 ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019
  10. Descendant · 4 generations on · 23 of its ownK222270 HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable…Globus Medical, Inc. · 2022
  11. Descendant · 3 generations on · 9 of its ownK211616 ExcelsiusHubGlobus Medical, Inc. · 2021 · Recalled (Class I)
Show all 10 generations
  1. Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 9 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 8 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 7 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 6 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 5 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 4 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 3 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
  9. 2 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  10. 1 generation backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
  11. This deviceK143039 CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015

Showing 5 of 79 descendants. See all descendants

Descendants cleared per year

2015: 12016: 12017: 22019: 52020: 12021: 42022: 72023: 92024: 152025: 152026: 19
2015high 19 (2026) · low 0 (2018)2026

Class I recalls in this family

  • K211616 ExcelsiusHub3 generations on · 2021

Most influential descendants

Showing 5 of 79 · See all
  • K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017 · cites it directly74descendants
  • K171651Excelsius GPSGlobus Medical, Inc. · 2017 · 2 generations on69descendants
  • K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019 · 3 generations on42descendants
  • K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc. · 2022 · 4 generations on23descendants
  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 3 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−9K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−8K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−7K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−6K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−5K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−4K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
−3K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007—
−2K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009—
−1K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011—
0 (this device)K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem2015—
+1K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.2017—
+2K171651Excelsius GPSGlobus Medical, Inc.20171
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.2019—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer…Globus Medical, Inc.2022—
+3K211616ExcelsiusHubGlobus Medical, Inc.2021Class I

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198110
198710
198940
199010
199110
199210
199320
199420
199540
199670
199830
199930
200070
200170
200250
200320
200440
200570
200670
200710
200840
200910
201020
201110
201410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201610
201720
201950
202010
202141
202270
202390
2024150
2025150
2026190
FIG. 1 — Lineage of K143039, 1996–2026Source: 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.

1 device in this family has a Class I recall. 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 HWC device

  1. #1 K203011 Monster Screw Systemscore 22.2 · 14 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? (9)

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
*K014154Vilex/Duval/Orthex Cannulated Bone Screw DB1 Thread, Model F25-XX-09; Vilex Solid Bone…
Summary page 4
…s are manufactured titanium alloy (ASTM F136) and stainless steel (ASTM F138). Predicate Devices: Dual-Thread and Lag Screws (Vilex Inc. – K014154) Dart-Fire Small and Charlotte Snap-off Screws (Wright Medical Technology – K08…
Vilex, Inc.2002—
*K082320Darco Small Screw
Summary page 4
…Thread and Lag Screws (Vilex Inc. – K014154) Dart-Fire Small and Charlotte Snap-off Screws (Wright Medical Technology – K082320, K100359 and K133713) M3-X Lag Screw (OsteoMed Corp. – K924018) Cannulated Scre…
Wrightmedicaltechnologyinc2008—
*K100359Darco Headed Cannulated Screw
Summary page 4
…d Lag Screws (Vilex Inc. – K014154) Dart-Fire Small and Charlotte Snap-off Screws (Wright Medical Technology – K082320, K100359 and K133713) M3-X Lag Screw (OsteoMed Corp. – K924018) Cannulated Screws and QF…
Wrightmedicaltechnologyinc2010—
*K133713Charlotte (TM) Snap-Off Screw
Summary page 4
…(Vilex Inc. – K014154) Dart-Fire Small and Charlotte Snap-off Screws (Wright Medical Technology – K082320, K100359 and K133713) M3-X Lag Screw (OsteoMed Corp. – K924018) Cannulated Screws and QFX Screw (Smi…
Wrightmedicaltechnologyinc2014—
*K924018M3 Lag Screw Fixation System
Summary page 4
…d Charlotte Snap-off Screws (Wright Medical Technology – K082320, K100359 and K133713) M3-X Lag Screw (OsteoMed Corp. – K924018) Cannulated Screws and QFX Screw (Smith & Nephew – K090675 and K111994)…
Osteomed Corp.1993—
*K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories
Summary page 4
…82320, K100359 and K133713) M3-X Lag Screw (OsteoMed Corp. – K924018) Cannulated Screws and QFX Screw (Smith & Nephew – K090675 and K111994) Herbert™ and Cannulated Screw System (Zimmer, Inc. – K102903 and…
Smith & Nephew, Inc.2009—
*K111994Smith & Nephew Cannulated Screws and Washers
Summary page 4
…M3-X Lag Screw (OsteoMed Corp. – K924018) Cannulated Screws and QFX Screw (Smith & Nephew – K090675 and K111994) Herbert™ and Cannulated Screw System (Zimmer, Inc. – K102903 and K112885) Subs…
Smith & Nephew, Inc.2011—
*K102903Pioneer Cannulated Screw System
Summary page 4
…ulated Screws and QFX Screw (Smith & Nephew – K090675 and K111994) Herbert™ and Cannulated Screw System (Zimmer, Inc. – K102903 and K112885) Substantial Theoretical analysis of the worst case CrossRoads screws was perfo…
Pioneer Surgical Technology, Inc.2010—
*K112885Zimmer Plates and Screws System Screws Only
Summary page 4
…Nephew – K090675 and K111994) Herbert™ and Cannulated Screw System (Zimmer, Inc. – K102903 and K112885) Substantial Theoretical analysis of the worst case CrossRoads screws was performed equivalence to pred…
Zimmer, Inc.201115

Also cleared against K014154: 15 other devices →

What descends from it? (79)

See all 79

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

NumberDeviceApplicantDecidedDescendants
K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774
K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153
K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
  • 19 of the 90 ancestors have a recall of any class.
  • Of its descendants, K162825 (Globus Medical, Inc., 2017) has gone furthest, with 74 descendants of its own.
  • 15 other devices also cite its predicate K014154.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.

Indications for use as stated in the FDA summary.

Also cleared against K014154

15 other devices cite the same predicate.

  • K250304TITANEX Screw SystemsVilex, LLC · 2025
  • K221342REDEMPTION Beaming SystemVilex, LLC · 2022
  • K200914Healix Compression Screw SystemNvision Biomedical Technologies, Inc. · 2020
  • K182949Healix™ Compression Screw SystemNvision Biomedical Technologies, LLC · 2018
  • K173286Cannulated Screw Internal Fixation SystemLife Spine, Inc. · 2017
  • K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited · 20171 recall

More from Orthodiscovery Group, LLC (D.B.A.…

2 FDA decisions under this applicant name. See the company

  • K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015

Recent decisions in HWC

The HWC category page

  • K261961Ntegrate Threaded Nail SystemNvision Biomedical Technologies · 2026
  • K263116OsteoCentric Technologies Cannulated and Soild Fasteners with NutsOsteoCentric Technologies · 2026
  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K143039 · printed Nov 6, 2026

Cite this page

510(k) Report. “K143039: CrossRoads Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143039

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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