510(k) Report

510(k) · Cleared

Cleared

Syntec-Taichung Non-Sterile DHS/DCS Plate System

K983873510(k) TraditionalCleared Dec 30, 199858-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

Syntec Scientific Corp. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Dec 30, 1998 after a 58-day review. The FDA summary names no predicate by number. 30 later devices descend from it.

Decided
Dec 30, 1998
Review
58 days
Class
Class II
Product code
KTT
Recalls
None
Predicates
0

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

Descendants, by year cleared 2006: 1 descendant cleared2008: 1 descendant cleared2009: 1 descendant cleared2019: 1 descendant cleared2012: 1 descendant cleared2010: 1 descendant cleared2018: 1 descendant cleared2015: 2 descendants cleared2011: 1 descendant cleared2016: 1 descendant cleared2017: 2 descendants cleared2023: 2 descendants cleared2022: 2 descendants cleared2024: 5 descendants cleared2021: 1 descendant cleared2014: 2 descendants cleared2025: 2 descendants cleared2026: 2 descendants cleared2020: 1 descendant cleared1995200020052010201520202025
  1. This deviceK983873 Syntec-Taichung Non-Sterile DHS/DCS Plate SystemSyntec Scientific Corp. · 1998
  2. Descendant · cites it directly · 29 of its ownK063020 Intai Bone Plate and Bone Screw System; Intai DHS/DCS Plate SystemIntai Technology, Inc. · 2006
  3. Descendant · cites it directly · 25 of its ownK072562 Microware Bone Plates and Bone ScrewsMicroware Precision Co., Ltd. · 2008
  4. Descendant · 2 generations on · 14 of its ownK092493 GPC Bone Plaes and Bone Screw & GPC DHS/DCS Plate SystemGpc Medical, Ltd. · 2010
  5. Descendant · 2 generations on · 11 of its ownK171904 Tandry Locking Plate SystemMicroware Precision Co., Ltd. · 2018
  6. Descendant · 3 generations on · 5 of its ownK110086 Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc. · 2011

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2006: 12008: 12009: 12010: 12011: 12012: 12014: 22015: 22016: 12017: 22018: 12019: 12020: 12021: 12022: 22023: 22024: 52025: 22026: 2
2006high 5 (2024) · low 0 (2007)2026

Most influential descendants

Showing 5 of 30 · See all
  • K063020Intai Bone Plate and Bone Screw System; Intai DHS/DCS Plate SystemIntai Technology, Inc. · 2006 · cites it directly29descendants
  • K072562Microware Bone Plates and Bone ScrewsMicroware Precision Co., Ltd. · 2008 · cites it directly25descendants
  • K092493GPC Bone Plaes and Bone Screw & GPC DHS/DCS Plate SystemGpc Medical, Ltd. · 2010 · 2 generations on14descendants
  • K171904Tandry Locking Plate SystemMicroware Precision Co., Ltd. · 2018 · 2 generations on11descendants
  • K110086Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc. · 2011 · 3 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K983873Syntec-Taichung Non-Sterile DHS/DCS Plate SystemSyntec Scientific Corp.1998—
+1K063020Intai Bone Plate and Bone Screw System; Intai DHS/DCS Plate SystemIntai Technology, Inc.2006—
+1K072562Microware Bone Plates and Bone ScrewsMicroware Precision Co., Ltd.2008—
+2K092493GPC Bone Plaes and Bone Screw & GPC DHS/DCS Plate SystemGpc Medical, Ltd.2010—
+2K171904Tandry Locking Plate SystemMicroware Precision Co., Ltd.2018—
+3K110086Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200810
200910
201010
201110
201210
201420
201520
201610
201720
201810
201910
202010
202110
202220
202320
202450
202520
202620
FIG. 1 — Lineage of K983873, 1998–2026Source: 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), 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
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (30)

See all 30

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

NumberDeviceApplicantDecidedDescendants
K063020Intai Bone Plate and Bone Screw System; Intai DHS/DCS Plate SystemIntai Technology, Inc.200629
K072562Microware Bone Plates and Bone ScrewsMicroware Precision Co., Ltd.200825

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, K063020 (Intai Technology, Inc., 2006) has gone furthest, with 29 descendants of its own.

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.

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 DHS/DCS Plate System is provided non-sterile. The device may be used for fixation of fractures of the proximal femur, such as femoral neck, trochanteric, pertrochanteric, or intertrochanteric zones.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Syntec Scientific Corp.

13 FDA decisions under this applicant name. See the company

  • K111189Syntec Dental ImplantSyntec Scientific Corp. · 2012
  • K101971Syntec OS Spinal Fixation SystemSyntec Scientific Corp. · 2011
  • K092889Syntec Osteo-Plate and Screw FixationSyntec Scientific Corp. · 2010
  • K090476Syntec Orthodontic Mini ScrewSyntec Scientific Corp. · 2009
  • K090839Modification to Syntec-Taichun Non-Sterile Bone Plate and Screw ImplantsSyntec Scientific Corp. · 2009

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The KTT category page

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https://510kreport.com/device/K983873 · printed Nov 6, 2026

Cite this page

510(k) Report. “K983873: Syntec-Taichung Non-Sterile DHS/DCS Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983873

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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