510(k) Report

510(k) · Cleared

Cleared

Intai Bone Plate and Bone Screw System; Intai DHS/DCS Plate System

K063020510(k) TraditionalCleared Dec 14, 200673-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

Intai Technology, Inc. · HRS Plate, Fixation, Bone

Cleared on Dec 14, 2006 as substantially equivalent to K983495 (Syntec Scientific Corp., 1998) and 1 other predicate after a 73-day review. Its family tree reaches back 1 generation to 1998. 29 later devices descend from it.

Decided
Dec 14, 2006
Review
73 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K983495 (1998). 2 ancestors in all. 29 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor2009: 1 descendant cleared2019: 1 descendant cleared2008: 1 descendant cleared2012: 1 descendant cleared2010: 1 descendant cleared2018: 1 descendant cleared2024: 5 descendants cleared2015: 2 descendants cleared2011: 1 descendant cleared2016: 1 descendant cleared2017: 2 descendants cleared2023: 2 descendants cleared2022: 2 descendants cleared2021: 1 descendant cleared2014: 2 descendants cleared2025: 2 descendants cleared2026: 2 descendants cleared2020: 1 descendant clearedK983495 · Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S 222020-248120, 240050-240980, 241130-246620, 4240420 · Syntec Scientific Corp. · 19981995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 11 descendants4 generations forward: 9 descendants5 generations forward: 2 descendants K983495 · Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S 222020-248120, 240050-240980, 241130-246620, 4240420 · Syntec Scientific Corp. · 19980+5
  1. Root · 1 generation backK983495 Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S…Syntec Scientific Corp. · 1998
  2. This deviceK063020 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
  7. Descendant · 3 generations on · 3 of its ownK161894 SurgTech Trauma SystemSurgtech, Inc. · 2017

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

2008: 12009: 12010: 12011: 12012: 12014: 22015: 22016: 12017: 22018: 12019: 12020: 12021: 12022: 22023: 22024: 52025: 22026: 2
2008high 5 (2024) · low 0 (2013)2026

Most influential descendants

Showing 5 of 29 · See all
  • 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
  • K161894SurgTech Trauma SystemSurgtech, Inc. · 2017 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K983495Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S…Syntec Scientific Corp.1998—
0 (this device)K063020Intai 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—
+3K161894SurgTech Trauma SystemSurgtech, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201010
201110
201210
201420
201520
201610
201720
201810
201910
202010
202110
202220
202320
202450
202520
202620
FIG. 1 — Lineage of K063020, 1998–2026Source: 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 HRS? 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 HRS device

  1. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 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? (2)

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
*K983495Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S 222020-248120…
Summary page 1
…combination, multiple component KTT - CFR 888.3030 Predicate devices SYNTEC-TAICHUNG NON-STERILE BO1)NE PLATE AND SCREW (K983495) SYNTEC-TAICHUNG NON-STERILE D/S/DCS PLATE SYSTEM (K983873) 1-1:! Materi…
Syntec Scientific Corp.1998—
*K983873Syntec-Taichung Non-Sterile DHS/DCS Plate System
Summary page 1
…KTT - CFR 888.3030 Predicate devices SYNTEC-TAICHUNG NON-STERILE BO1)NE PLATE AND SCREW (K983495) SYNTEC-TAICHUNG NON-STERILE D/S/DCS PLATE SYSTEM (K983873) 1-1:! Material The devices are manufactured from medic 11 grade 3 16L st…
Syntec Scientific Corp.1998—

Also cleared against K983495: 10 other devices →

What descends from it? (29)

See all 29

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

NumberDeviceApplicantDecidedDescendants
K072562Microware Bone Plates and Bone ScrewsMicroware Precision Co., Ltd.200825
K190830TDM Screw SystemsTdm Co., Ltd.20191
K090786Kens Internal Fixation SystemKens Finemedtech Sdn. Bhd20091

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 2 ancestors has a recall.
  • Of its descendants, K072562 (Microware Precision Co., Ltd., 2008) has gone furthest, with 25 descendants of its own.
  • 10 other devices also cite its predicate K983495.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

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

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

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

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, 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
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

What is it indicated for?

The Bone Plate and Bone Screw System and the DHS/DCS Plate System are provided non-sterile.

The Bone Plate and Bone Screw System is intended for use in fixation of fractures to the various bones, including the clavicle, pelvis, scapula, calcaneus, long bone (humerus, ulna, radius, femur, tibia, and fibula), and small bone (metacarpals, metatarsals, and phalanges).

The DHS/DCS Plate System is intended for use in fixation of fractures to the proximal femur. The system is indicated for use in trochanteric, pertrochanteric, intertrochanteric, and basilar neck fractures.

Indications for use as stated in the FDA summary.

Also cleared against K983495

10 other devices cite the same predicate.

  • K191009Arsenal Plating SystemTrilliant Surgical · 2019
  • K181113CoLink™ Afx Plating SystemIn2bones USA, LLC · 2018
  • K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC · 20171 recall
  • K150376Sonoma Cancellous Bone Screw and WasherSonoma Orthopedics Products, Inc. · 2015
  • K111432Evolve (R) Triad (TM) Plating System and Evolve (R) Triad (TM) Bone ScrewsWrightmedicaltechnologyinc · 2011
  • K092889Syntec Osteo-Plate and Screw FixationSyntec Scientific Corp. · 2010

Recent decisions in HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K063020 · printed Nov 5, 2026

Cite this page

510(k) Report. “K063020: Intai Bone Plate and Bone Screw System; Intai DHS/DCS Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063020

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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