510(k) Report

510(k) · Cleared

Cleared

Modular Foot System - 2.7 MM Module

K010321510(k) TraditionalCleared May 2, 200189-day reviewClass II21 CFR 888.3030

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

Synthes (Usa) · KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component

Cleared on May 2, 2001 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 200 later devices descend from it.

Decided
May 2, 2001
Review
89 days
Class
Class II
Product code
KTW
Recalls
None
Predicates
0

200 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2015: 9 descendants cleared2025: 15 descendants cleared2023: 17 descendants cleared2014: 6 descendants cleared2006: 3 descendants cleared2011: 2 descendants cleared2019: 13 descendants cleared2007: 3 descendants cleared2010: 1 descendant cleared2012: 5 descendants cleared2009: 1 descendant cleared2008: 1 descendant cleared2018: 8 descendants cleared2016: 5 descendants cleared2021: 22 descendants cleared2024: 20 descendants cleared2017: 14 descendants cleared2022: 11 descendants cleared2020: 15 descendants cleared2026: 27 descendants cleared2013: 2 descendants cleared200020052010201520202025
  1. This deviceK010321 Modular Foot System - 2.7 MM ModuleSynthes (Usa) · 2001
  2. Descendant · cites it directly · 118 of its ownK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
  3. Descendant · cites it directly · 76 of its ownK060473 TTC PlateNew Deal, S.A. · 2006
  4. Descendant · 2 generations on · 73 of its ownK073375 Newdeal Tibiaxys SystemNewdeal Sas · 2008 · Recalled
  5. Descendant · 2 generations on · 69 of its ownK110670 VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc…Smith & Nephew, Inc. · 2011
  6. Descendant · 2 generations on · 56 of its ownK100176 Ascension Ankle Fusion Plate SystemAscension Orthopedics, Inc. · 2010

Showing 5 of 200 descendants. See all descendants

Descendants cleared per year

2006: 32007: 32008: 12009: 12010: 12011: 22012: 52013: 22014: 62015: 92016: 52017: 142018: 82019: 132020: 152021: 222022: 112023: 172024: 202025: 152026: 27
2006high 27 (2026) · low 1 (2008)2026

Most influential descendants

Showing 5 of 200 · See all
  • K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011 · cites it directly118descendants
  • K060473TTC PlateNew Deal, S.A. · 2006 · cites it directly76descendants
  • K073375Newdeal Tibiaxys SystemNewdeal Sas · 2008 · 2 generations on73descendants
  • K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc. · 2011 · 2 generations on69descendants
  • K100176Ascension Ankle Fusion Plate SystemAscension Orthopedics, Inc. · 2010 · 2 generations on56descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010321Modular Foot System - 2.7 MM ModuleSynthes (Usa)2001—
+1K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011—
+1K060473TTC PlateNew Deal, S.A.2006—
+2K073375Newdeal Tibiaxys SystemNewdeal Sas20082
+2K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone…Smith & Nephew, Inc.2011—
+2K100176Ascension Ankle Fusion Plate SystemAscension Orthopedics, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200630
200730
200810
200910
201010
201120
201250
201320
201460
201590
201650
2017140
201880
2019130
2020150
2021220
2022110
2023170
2024200
2025150
2026270
FIG. 1 — Lineage of K010321, 2001–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KTW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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? (200)

See all 200

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

NumberDeviceApplicantDecidedDescendants
K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011118
K060473TTC PlateNew Deal, S.A.200676
K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH20152
K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231
K060474Lisfranc PlateNew Deal, S.A.20061
K060476Lapidus PlateNew Deal, S.A.20061
K242988Genostis Osteosynthesis SystemGenostis AF20250
K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes20190
K133536Emerge Medical Bone Plate SystemEmerge Medical20140

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, K112583 (Synthes (USA) Products, LLC, 2011) has gone furthest, with 118 descendants of its own.

How does its category compare?

All KTW devices

KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KTW

1in 2019

2008: 22012: 12016: 12017: 22019: 1
2007high 2 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTW

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

Recalls per year · KTW

57in 2010

2010: 57
2007high 57 (2010) · low 0 (2007)2026

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

Adverse event reports per year · KTW

96in 2025

2007: 32008: 102009: 22010: 262011: 212012: 702013: 702014: 622015: 262016: 412017: 272018: 242019: 112020: 602021: 252022: 502023: 302024: 1232025: 96
2007high 123 (2024) · low 2 (2009)2025

MAUDE reports naming product code KTW, 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—03
20082—010
20090—02
20100—5726
20110—021
20121—070
20130—070
20140—062
20150—026
20161—041
20172—027
20180—024
20191—011
20200—060
20210—025
20220—050
20230—030
20240—0123
20250—096
20260—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 KTW

The KTW category page

  • K182285PK High Tibial Osteotomy Correction SystemPaonan Biotech Co., Ltd. · 2019
  • K171606AOS Anterolateral Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc. (Aos) · 2017
  • K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc. · 2017
  • K160409AOS Anterolateral Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc. · 2016
  • K122541Orthofix Contours Proimal Humeral Plate (PHP)Orthofix Srl · 2012

https://510kreport.com/device/K010321 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010321: Modular Foot System - 2.7 MM Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010321

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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