510(k) Report

510(k) · Cleared

Cleared

4.0/2.5 MM Self-Drilling Schanz Screw

K002605510(k) TraditionalCleared Nov 20, 200090-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 Nov 20, 2000 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 49 later devices descend from it.

Decided
Nov 20, 2000
Review
90 days
Class
Class II
Product code
JDW
Recalls
None
Predicates
0

49 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2011: 5 descendants cleared2013: 2 descendants cleared2014: 2 descendants cleared2012: 3 descendants cleared2010: 1 descendant cleared2017: 6 descendants cleared2015: 5 descendants cleared2016: 3 descendants cleared2018: 2 descendants cleared2025: 4 descendants cleared2020: 2 descendants cleared2024: 1 descendant cleared2021: 3 descendants cleared2023: 1 descendant cleared2022: 3 descendants cleared2026: 5 descendants cleared200020052010201520202025
  1. This deviceK002605 4.0/2.5 MM Self-Drilling Schanz ScrewSynthes (Usa) · 2000
  2. Descendant · cites it directly · 48 of its ownK083912 Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins…Treu-Instrumente GmbH · 2009
  3. Descendant · 2 generations on · 9 of its ownK112727 Medical Facets Corical Screws, Medical Facets Cancellous Screws…Medical Facets · 2012
  4. Descendant · 2 generations on · 8 of its ownK110895 Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited · 2011
  5. Descendant · 2 generations on · 8 of its ownK102845 Mahe Fixation Plate and Screw SystemMahe Medical GmbH · 2011
  6. Descendant · 2 generations on · 5 of its ownK132820 Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc. · 2014

Showing 5 of 49 descendants. See all descendants

Descendants cleared per year

2009: 12010: 12011: 52012: 32013: 22014: 22015: 52016: 32017: 62018: 22020: 22021: 32022: 32023: 12024: 12025: 42026: 5
2009high 6 (2017) · low 0 (2019)2026

Most influential descendants

Showing 5 of 49 · See all
  • K083912Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen PinsTreu-Instrumente GmbH · 2009 · cites it directly48descendants
  • K112727Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless…Medical Facets · 2012 · 2 generations on9descendants
  • K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited · 2011 · 2 generations on8descendants
  • K102845Mahe Fixation Plate and Screw SystemMahe Medical GmbH · 2011 · 2 generations on8descendants
  • K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc. · 2014 · 2 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K0026054.0/2.5 MM Self-Drilling Schanz ScrewSynthes (Usa)2000—
+1K083912Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen PinsTreu-Instrumente GmbH2009—
+2K112727Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical…Medical Facets2012—
+2K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited2011—
+2K102845Mahe Fixation Plate and Screw SystemMahe Medical GmbH2011—
+2K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
201150
201230
201320
201420
201550
201630
201760
201820
202020
202130
202230
202310
202410
202540
202650
FIG. 1 — Lineage of K002605, 2000–2026Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (49)

See all 49

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

NumberDeviceApplicantDecidedDescendants
K083912Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen PinsTreu-Instrumente GmbH200948

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, K083912 (Treu-Instrumente GmbH, 2009) has gone furthest, with 48 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—

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/K002605 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002605: 4.0/2.5 MM Self-Drilling Schanz Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002605

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026