510(k) Report

510(k) · Cleared

Cleared

Leforte System Bone Plate

K023360510(k) TraditionalCleared Oct 25, 200218-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

Jeil Medical Corporation · KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component

Cleared on Oct 25, 2002 as substantially equivalent to K972323 (Osteonics Corp., 1997) and 2 other predicates after an 18-day review. Its family tree reaches back 1 generation to 1997. 20 later devices descend from it.

Decided
Oct 25, 2002
Review
18 days
Class
Class II
Product code
KTW
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K972323 (1997). 3 ancestors in all. 20 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 2 other ancestors2013: 2 descendants cleared2005: 1 descendant cleared2019: 4 descendants cleared2018: 2 descendants cleared2015: 1 descendant cleared2017: 3 descendants cleared2016: 1 descendant cleared2020: 1 descendant cleared2023: 2 descendants cleared2022: 1 descendant cleared2021: 1 descendant cleared2025: 1 descendant clearedK972323 · Osteo Bos System · Osteonics Corp. · 19971995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 6 descendants3 generations forward: 9 descendants4 generations forward: 2 descendants K972323 · Osteo Bos System · Osteonics Corp. · 19970
  1. Root · 1 generation backK972323 Osteo Bos SystemOsteonics Corp. · 1997
  2. This deviceK023360 Leforte System Bone PlateJeil Medical Corporation · 2002
  3. Descendant · cites it directly · 9 of its ownK131311 Arix Foot SystemJeil Medical Corporation · 2013
  4. Descendant · cites it directly · 8 of its ownK050669 Jeil Bone Fixation SystemJeil Medical Corporation · 2005
  5. Descendant · 2 generations on · 5 of its ownK161864 ARIX Foot SystemJeil Medical Corporation · 2016
  6. Descendant · 3 generations on · 4 of its ownK172260 Omni Foot Plating SystemExtremity Medical, LLC · 2017
  7. Descendant · 2 generations on · 4 of its ownK170780 ARIX Foot System (2.3/2.8)Jeil Medical Corporation · 2017

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2005: 12013: 22015: 12016: 12017: 32018: 22019: 42020: 12021: 12022: 12023: 22025: 1
2005high 4 (2019) · low 0 (2006)2026

Most influential descendants

Showing 5 of 20 · See all
  • K131311Arix Foot SystemJeil Medical Corporation · 2013 · cites it directly9descendants
  • K050669Jeil Bone Fixation SystemJeil Medical Corporation · 2005 · cites it directly8descendants
  • K161864ARIX Foot SystemJeil Medical Corporation · 2016 · 2 generations on5descendants
  • K172260Omni Foot Plating SystemExtremity Medical, LLC · 2017 · 3 generations on4descendants
  • K170780ARIX Foot System (2.3/2.8)Jeil Medical Corporation · 2017 · 2 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K972323Osteo Bos SystemOsteonics Corp.1997—
0 (this device)K023360Leforte System Bone PlateJeil Medical Corporation2002—
+1K131311Arix Foot SystemJeil Medical Corporation2013—
+1K050669Jeil Bone Fixation SystemJeil Medical Corporation2005—
+2K161864ARIX Foot SystemJeil Medical Corporation2016—
+3K172260Omni Foot Plating SystemExtremity Medical, LLC2017—
+2K170780ARIX Foot System (2.3/2.8)Jeil Medical Corporation2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199920

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
201320
201510
201610
201730
201820
201940
202010
202110
202210
202320
202510
FIG. 1 — Lineage of K023360, 1997–2025Source: 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 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? (3)

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
*K972323Osteo Bos System
Summary page 1
…m Bone Plate Classification Name: Plate, Fixation, Bone, Product Code HRS CommodUsual Name: Bone Plate 2. Equivalent legally marketed device: Osteo BOS" System, K972323; Lorenz Small Fragment System, K99296 1 ; and Syntec-Taichung Non-sterile Titanium Mimi Plate, K98398 8 3. Indications for…
Osteonics Corp.1997—
*K992961Lorenz Small Fragment System
Summary page 1
…e, Fixation, Bone, Product Code HRS CommodUsual Name: Bone Plate 2. Equivalent legally marketed device: Osteo BOS" System, K972323; Lorenz Small Fragment System, K99296 1 ; and Syntec-Taichung Non-sterile Titanium Mimi Plate, K98398 8 3. Indications for Use (intended use) . The device is used fo…
Walter Lorenz Surgical, Inc.1999—
*K983988Syntec-Taichung Non-Sterile Titanium Alloy Mini-Plate
Summary page 1
…e 2. Equivalent legally marketed device: Osteo BOS" System, K972323; Lorenz Small Fragment System, K99296 1 ; and Syntec-Taichung Non-sterile Titanium Mimi Plate, K98398 8 3. Indications for Use (intended use) . The device is used for internal fracture fixation of small bone (toe, finger etc) and…
Syntec Scientific Corp.1999—

Also cleared against K972323: 3 other devices →

What descends from it? (20)

See all 20

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

NumberDeviceApplicantDecidedDescendants
K131311Arix Foot SystemJeil Medical Corporation20139
K050669Jeil Bone Fixation SystemJeil Medical Corporation20058
K132876Arix Hand Locking SystemJeil Medical Corporation20130

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K131311 (Jeil Medical Corporation, 2013) has gone furthest, with 9 descendants of its own.
  • 3 other devices also cite its predicate K972323.

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—

What is it indicated for?

The device is used for internal fracture fixation of small bone (toe,

finger etc) and reconstruction of Mandible & Maxilla. (Craniomaxillofacial Skeleton).

Indications for use as stated in the FDA summary.

Also cleared against K972323

3 other devices cite the same predicate.

  • K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH · 2023
  • K133440Axsos 3 TI Locking Plate System Line ExtensionStryker Trauma AG · 2013
  • K123964Axsos 3 TI Locking Plate SystemStryker Trauma AG · 2013

More from Jeil Medical Corporation

53 FDA decisions under this applicant name. See the company

  • K252246Leforte MMF SystemJeil Medical Corporation · 2026
  • K252826ARIX Femur Nail SystemJeil Medical Corporation · 2025
  • K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation · 2025
  • K243973FIX-L PEEK PLIF and T-PLIF SystemJeil Medical Corporation · 2025
  • K242751ARIX Pectus Bar SystemJeil Medical Corporation · 2025

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/K023360 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023360: Leforte System Bone Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023360

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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