510(k) Report

510(k) · Cleared

Cleared

Targon FN System

K102057510(k) TraditionalCleared Dec 21, 2010152-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

Aesculap Implant Systems, LLC · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Dec 21, 2010 as substantially equivalent to K953607 (Synthes (Usa), 1996) after a 152-day review. Its family tree reaches back 1 generation to 1996. 13 later devices descend from it.

Decided
Dec 21, 2010
Review
152 days
Class
Class II
Product code
KTT
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K953607 (1996). 13 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2016: 1 descendant cleared2017: 1 descendant cleared2020: 1 descendant cleared2022: 1 descendant cleared2021: 2 descendants cleared2025: 2 descendants cleared2023: 3 descendants cleared2026: 2 descendants clearedK953607 · Titanium Limited Contact Dynamic Hip Screw Plate (Tilc-DHS) · Synthes (Usa) · 19961995200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 6 descendants4 generations forward: 2 descendants K953607 · Titanium Limited Contact Dynamic Hip Screw Plate (Tilc-DHS) · Synthes (Usa) · 19960
  1. Root · 1 generation backK953607 Titanium Limited Contact Dynamic Hip Screw Plate (Tilc-DHS)Synthes (Usa) · 1996
  2. This deviceK102057 Targon FN SystemAesculap Implant Systems, LLC · 2010
  3. Descendant · cites it directly · 12 of its ownK152686 Conquest FNSmith & Nephew · 2016
  4. Descendant · 2 generations on · 10 of its ownK193029 Conquest FNSmith & Nephew, Inc. · 2020
  5. Descendant · cites it directly · 8 of its ownK172785 Conquest FNSmith & Nephew · 2017
  6. Descendant · 2 generations on · 7 of its ownK210837 Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 2021 · Recalled
  7. Descendant · 2 generations on · 2 of its ownK213126 Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc…Smith & Nephew, Inc. · 2022 · Recalled

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2016: 12017: 12020: 12021: 22022: 12023: 32025: 22026: 2
2016high 3 (2023) · low 0 (2018)2026

Most influential descendants

Showing 5 of 13 · See all
  • K152686Conquest FNSmith & Nephew · 2016 · cites it directly12descendants
  • K193029Conquest FNSmith & Nephew, Inc. · 2020 · 2 generations on10descendants
  • K172785Conquest FNSmith & Nephew · 2017 · cites it directly8descendants
  • K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 2021 · 2 generations on7descendants
  • K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc. · 2022 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K953607Titanium Limited Contact Dynamic Hip Screw Plate (Tilc-DHS)Synthes (Usa)1996—
0 (this device)K102057Targon FN SystemAesculap Implant Systems, LLC2010—
+1K152686Conquest FNSmith & Nephew2016—
+2K193029Conquest FNSmith & Nephew, Inc.2020—
+1K172785Conquest FNSmith & Nephew2017—
+2K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.20211
+2K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100…Smith & Nephew, Inc.20221

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201710
202010
202120
202210
202330
202520
202620
FIG. 1 — Lineage of K102057, 1996–2026Source: 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 KTT? 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 KTT device

  1. #1 K242861 TrueLok Elevatescore 21.3 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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
*K953607Titanium Limited Contact Dynamic Hip Screw Plate (Tilc-DHS)
Summary page 1
…esculap Implant Systems, LLC, believes that the Targon FN System is substantially equivalent to the Synthes Titanium Limited Contact Dynamic Hip Screw Plate [TILO- OHS] (K953607). DEVICE DESCRIPTION The Aesculap Implant Systems Targon FN System consists of a single tapered plate and screws (cancellous and…
Synthes (Usa)1996—

Also cleared against K953607: 7 other devices →

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K152686Conquest FNSmith & Nephew201612
K172785Conquest FNSmith & Nephew20178

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?

  • Its one ancestor has no recall.
  • Of its descendants, K152686 (Smith & Nephew, 2016) has gone furthest, with 12 descendants of its own.
  • 7 other devices also cite its predicate K953607.

How does its category compare?

All KTT devices

KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · KTT

10in 2025

2007: 92008: 112009: 112010: 122011: 102012: 92013: 72014: 142015: 122016: 102017: 112018: 62019: 82020: 92021: 102022: 32023: 72024: 52025: 102026 (partial year): 5
2007high 14 (2014) · low 3 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTT

88in 2025

2007: 55 days median2008: 73 days median2009: 94 days median2010: 148 days median2011: 157 days median2012: 140 days median2013: 87 days median2014: 129 days median2015: 60 days median2016: 142 days median2017: 184 days median2018: 149 days median2019: 110 days median2020: 200 days median2021: 83 days median2022: 25 days median2023: 29 days median2024: 90 days median2025: 88 days median2026 (partial year): 68 days median
2007high 200 (2020) · low 25 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KTT

2in 2021

2007: 22008: 12009: 22010: 12012: 42013: 72017: 12018: 142019: 32021: 22026 (partial year): 11
2007high 14 (2018) · low 0 (2011)2026

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

Adverse event reports per year · KTT

673in 2025

2007: 452008: 662009: 452010: 1212011: 1962012: 5272013: 8982014: 4452015: 4012016: 4002017: 4852018: 5972019: 8002020: 9422021: 9612022: 6272023: 5542024: 5232025: 673
2007high 961 (2021) · low 45 (2007)2025

MAUDE reports naming product code KTT, 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
2007955245
20081173166
20091194245
2010121481121
2011101570196
201291404527
20137877898
2014141290445
201512600401
2016101420400
2017111841485
2018614914597
201981103800
202092000942
202110832961
20223250627
20237290554
20245900523
202510880673
202656811—

What is it indicated for?

The Aesculap Implant Systems Targon FN System is intended to be used for splinting, stabilization and fixation of the proximal femur.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K102057: Targon FN System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102057

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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