510(k) Report

510(k) · Cleared

Cleared

Synthes 5.0/7.3 MM Cannulated Locking Screws

K040765510(k) TraditionalCleared Apr 12, 200418-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

Synthes (Usa) · JDW Pin, Fixation, Threaded

Cleared on Apr 12, 2004 after an 18-day review. The FDA summary names its predicate without a number. 173 later devices descend from it.

Decided
Apr 12, 2004
Review
18 days
Class
Class II
Product code
JDW
Recalls
None
Predicates
0

173 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2019: 4 descendants cleared2014: 3 descendants cleared2017: 6 descendants cleared2020: 9 descendants cleared2010: 1 descendant cleared2022: 25 descendants cleared2021: 15 descendants cleared2012: 1 descendant cleared2018: 3 descendants cleared2026: 23 descendants cleared2023: 25 descendants cleared2024: 24 descendants cleared2015: 2 descendants cleared2016: 3 descendants cleared2013: 2 descendants cleared2025: 26 descendants cleared200020052010201520202025
  1. This deviceK040765 Synthes 5.0/7.3 MM Cannulated Locking ScrewsSynthes (Usa) · 2004
  2. Descendant · cites it directly · 168 of its ownK082874 Biodrive Cannulated Screw SystemBiomet Trauma · 2009
  3. Descendant · 2 generations on · 143 of its ownK093629 Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine · 2010 · Recalled
  4. Descendant · 3 generations on · 142 of its ownK113796 Solitaire-C Cervical Spacer SystemEbi, LLC · 2012 · Recalled
  5. Descendant · 4 generations on · 108 of its ownK132029 Vault-C Intervertebral Body Fusion DeviceSpinal USA · 2013
  6. Descendant · 5 generations on · 93 of its ownK190546 NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019

Showing 5 of 173 descendants. See all descendants

Descendants cleared per year

2009: 12010: 12012: 12013: 22014: 32015: 22016: 32017: 62018: 32019: 42020: 92021: 152022: 252023: 252024: 242025: 262026: 23
2009high 26 (2025) · low 0 (2011)2026

Most influential descendants

Showing 5 of 173 · See all
  • K082874Biodrive Cannulated Screw SystemBiomet Trauma · 2009 · cites it directly168descendants
  • K093629Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine · 2010 · 2 generations on143descendants
  • K113796Solitaire-C Cervical Spacer SystemEbi, LLC · 2012 · 3 generations on142descendants
  • K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA · 2013 · 4 generations on108descendants
  • K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019 · 5 generations on93descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K040765Synthes 5.0/7.3 MM Cannulated Locking ScrewsSynthes (Usa)2004—
+1K082874Biodrive Cannulated Screw SystemBiomet Trauma2009—
+2K093629Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine20101
+3K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121
+4K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013—
+5K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
201210
201320
201430
201520
201630
201760
201830
201940
202090
2021150
2022250
2023250
2024240
2025260
2026230
FIG. 1 — Lineage of K040765, 2004–2026Source: 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.

Planning a device in JDW? 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 JDW device

  1. #1 K260073 XT3 System; XT3 System, Mini; XT3 System…score 15.0 · 15 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
*—Synthes 5.0/7.3 mm Cannulated Locking Screws
Named without a submission number
—

What descends from it? (173)

See all 173

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

NumberDeviceApplicantDecidedDescendants
K082874Biodrive Cannulated Screw SystemBiomet Trauma2009168
K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195

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?

  • Of its descendants, K082874 (Biomet Trauma, 2009) has gone furthest, with 168 descendants of its own.

How does its category compare?

All JDW devices

JDW Pin, Fixation, Threaded: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDW

2in 2025

2007: 22009: 12010: 22011: 12012: 12013: 22014: 22015: 12017: 12018: 12019: 12020: 22021: 22022: 22025: 22026 (partial year): 1
2007high 2 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDW

Too few JDW 510(k)s in any year since 2007 to give a median.

Recalls per year · JDW

21in 2018

2009: 22010: 22012: 522017: 22018: 21
2007high 52 (2012) · low 0 (2007)2026

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

Adverse event reports per year · JDW

29in 2025

2007: 252008: 262009: 292010: 292011: 552012: 752013: 692014: 272015: 702016: 462017: 432018: 942019: 5752020: 4022021: 1682022: 1212023: 722024: 652025: 29
2007high 575 (2019) · low 25 (2007)2025

MAUDE reports naming product code JDW, 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
20072—025
20080—026
20091—229
20102—229
20111—055
20121—5275
20132—069
20142—027
20151—070
20160—046
20171—243
20181—2194
20191—0575
20202—0402
20212—0168
20222—0121
20230—072
20240—065
20252—029
20261—0—

What is it indicated for?

Synthes 5.0/7.3 mm Cannualted Locking Screws are intended to be used with existing Synthes LCP® plating systems for the fixation of various long bones, such as the femur.

Indications for use as stated in the FDA summary.

More from Synthes (Usa)

406 FDA decisions under this applicant name. See the company

  • K131984Synthes Synsonic Ulna NailSynthes (Usa) · 2014
  • K111667Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 20111 recall
  • K111540Synthes 3.5MM LCP Clavicle Plate SystemSynthes (Usa) · 2011
  • K110789Synthes Sternal Zipfix SystemSynthes (Usa) · 20113 recalls
  • K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) · 20112 recalls

Recent decisions in JDW

The JDW category page

  • K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc. · 2026
  • K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLC · 2025
  • K241357XT3 SystemBiodynamik, Inc. · 2025
  • K223112MAVERICK Mini External Fixation SystemSmith & Nephew, Inc. · 2022
  • K213874MAVERICK External Fixation SystemSmith & Nephew, Inc. · 2022

https://510kreport.com/device/K040765 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040765: Synthes 5.0/7.3 MM Cannulated Locking Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040765

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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