510(k) Report

510(k) · Cleared

Cleared

Emerge Medical Cannulated Screw Fixation System

K102343510(k) TraditionalCleared Nov 23, 201098-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

Emerge Medical · HWC Screw, Fixation, Bone

Cleared on Nov 23, 2010 as substantially equivalent to K962011 (Synthes (Usa), 1996) and 5 other predicates after a 98-day review. Its family tree reaches back 1 generation to 1996. 220 later devices descend from it.

Decided
Nov 23, 2010
Review
98 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K962011 (1996). 6 ancestors in all. 220 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2001: 1 other ancestor1996: 3 other ancestors2011: 3 descendants cleared2013: 7 descendants cleared2024: 22 descendants cleared2014: 8 descendants cleared2017: 23 descendants cleared2020: 19 descendants cleared2019: 13 descendants cleared2015: 12 descendants cleared2025: 21 descendants cleared2012: 2 descendants cleared2026: 30 descendants cleared2022: 15 descendants cleared2018: 8 descendants cleared2023: 19 descendants cleared2021: 16 descendants cleared2016: 2 descendants clearedK962011 · Synthes 7.0/7.3 MM Cannulated Screws · Synthes (Usa) · 19961995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors 1 generation forward: 1 descendant2 generations forward: 22 descendants3 generations forward: 63 descendants4 generations forward: 72 descendants5 generations forward: 38 descendants6 generations forward: 16 descendants7 generations forward: 5 descendants8 generations forward: 2 descendants9 generations forward: 1 descendant K962011 · Synthes 7.0/7.3 MM Cannulated Screws · Synthes (Usa) · 19960+5
  1. Root · 1 generation backK962011 Synthes 7.0/7.3 MM Cannulated ScrewsSynthes (Usa) · 1996
  2. This deviceK102343 Emerge Medical Cannulated Screw Fixation SystemEmerge Medical · 2010
  3. Descendant · cites it directly · 219 of its ownK103705 Low Profile ScrewsArthrex, Inc. · 2011
  4. Descendant · 2 generations on · 135 of its ownK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
  5. Descendant · 2 generations on · 91 of its ownK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
  6. Descendant · 2 generations on · 71 of its ownK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
  7. Descendant · 2 generations on · 58 of its ownK111678 Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · Recalled

Showing 5 of 220 descendants. See all descendants

Descendants cleared per year

2011: 32012: 22013: 72014: 82015: 122016: 22017: 232018: 82019: 132020: 192021: 162022: 152023: 192024: 222025: 212026: 30
2011high 30 (2026) · low 2 (2012)2026

Most influential descendants

Showing 5 of 220 · See all
  • K103705Low Profile ScrewsArthrex, Inc. · 2011 · cites it directly219descendants
  • K111253Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011 · 2 generations on135descendants
  • K112437Arthrex Fracture SystemArthrex, Inc. · 2011 · 2 generations on91descendants
  • K123241Arthrex Fracture PlatesArthrex, Inc. · 2013 · 2 generations on71descendants
  • K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · 2 generations on58descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K962011Synthes 7.0/7.3 MM Cannulated ScrewsSynthes (Usa)1996—
0 (this device)K102343Emerge Medical Cannulated Screw Fixation SystemEmerge Medical2010—
+1K103705Low Profile ScrewsArthrex, Inc.2011—
+2K111253Arthrex Distal Extremity Plate SystemArthrex, Inc.2011—
+2K112437Arthrex Fracture SystemArthrex, Inc.2011—
+2K123241Arthrex Fracture PlatesArthrex, Inc.2013—
+2K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited20121

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199630
200110
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201130
201220
201370
201480
2015120
201620
2017230
201880
2019130
2020190
2021160
2022150
2023190
2024220
2025210
2026300
FIG. 1 — Lineage of K102343, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 HWC? 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? (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
*K962011Synthes 7.0/7.3 MM Cannulated Screws
Summary page 1
…ne Regulation: 21 CFR 888.3040 (Smooth or threaded metallic bone fixation fastener) Product Code: HWC Predicate Devices: Synthes Cannulated Screw System: K96201 1 (7.0, 7.3mm) K962823 (3.Omm) K963 172 (4.5mm) K963 192 (3.5, 4.0mm) K0 12945 (2.4mm)…
Synthes (Usa)1996—
*K962823Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer
Summary page 1
…40 (Smooth or threaded metallic bone fixation fastener) Product Code: HWC Predicate Devices: Synthes Cannulated Screw System: K96201 1 (7.0, 7.3mm) K962823 (3.Omm) K963 172 (4.5mm) K963 192 (3.5, 4.0mm) K0 12945 (2.4mm) K02 1932 (6.5mm) Descrip…
Synthes (Usa)1996—
*K963172Synthes Sterile 4.5 MM Cannulated Screws
Summary page 1
…allic bone fixation fastener) Product Code: HWC Predicate Devices: Synthes Cannulated Screw System: K96201 1 (7.0, 7.3mm) K962823 (3.Omm) K963 172 (4.5mm) K963 192 (3.5, 4.0mm) K0 12945 (2.4mm) K02 1932 (6.5mm) Description of the Device: -…
Synthes (Usa)1996—
*K963192Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws
Summary page 1
…r) Product Code: HWC Predicate Devices: Synthes Cannulated Screw System: K96201 1 (7.0, 7.3mm) K962823 (3.Omm) K963 172 (4.5mm) K963 192 (3.5, 4.0mm) K0 12945 (2.4mm) K02 1932 (6.5mm) Description of the Device: - The Emerge Medical Cannulat…
Synthes (Usa)1996—
*K012945Synthes 2.4 MM Cannulated Screw
Summary page 1
…Devices: Synthes Cannulated Screw System: K96201 1 (7.0, 7.3mm) K962823 (3.Omm) K963 172 (4.5mm) K963 192 (3.5, 4.0mm) K0 12945 (2.4mm) K02 1932 (6.5mm) Description of the Device: - The Emerge Medical Cannulated Bone Screw set consists of va…
Synthes (Usa)20011
*K021932Synthes 6.5 MM Cannulated Screw
Summary page 1
…d Screw System: K96201 1 (7.0, 7.3mm) K962823 (3.Omm) K963 172 (4.5mm) K963 192 (3.5, 4.0mm) K0 12945 (2.4mm) K02 1932 (6.5mm) Description of the Device: - The Emerge Medical Cannulated Bone Screw set consists of various size bone screws. The…
Synthes (Usa)20027

Also cleared against K962011: 26 other devices →

What descends from it? (220)

See all 220

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K103705Low Profile ScrewsArthrex, Inc.2011219

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?

  • 2 of the 6 ancestors have a recall of any class.
  • Of its descendants, K103705 (Arthrex, Inc., 2011) has gone furthest, with 219 descendants of its own.
  • 26 other devices also cite its predicate K962011.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Emerge Medical Cannulated Screw Fixation System is intended to provide bone fixation in the management of fractures of both small and large bones and bone fragments, including those in the foot, patella, ankle, wrist, and elbow and arthrodesis of the foot, wrist, and elbow and small and long bone osteotomies.

Indications for use as stated in the FDA summary.

Also cleared against K962011

26 other devices cite the same predicate.

  • K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company · 2022
  • K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® InstrumentsGlobus Medical, Inc. · 2019
  • K173201UNITY Sacroiliac Joint Fixation SystemHuvexel Co., Ltd. · 2018
  • K171595M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A. · 2017
  • K170021SMV Scientific Cannulated ScrewsSmv Scientific · 2017
  • K161894SurgTech Trauma SystemSurgtech, Inc. · 2017

More from Emerge Medical

10 FDA decisions under this applicant name. See the company

  • K141347Emerge Medical IM Nail SystemEmerge Medical · 2014
  • K140107Emerge Medical Distal Radius SetEmerge Medical · 2014
  • K140098Emerge Medical Small Fragment Locked Plating SystemEmerge Medical · 2014
  • K140119Emerge Medical Periarticular and Locking Large Fragment SystemEmerge Medical · 2014
  • K133536Emerge Medical Bone Plate SystemEmerge Medical · 2014

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/K102343 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102343: Emerge Medical Cannulated Screw Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102343

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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