510(k) Report

510(k) · Cleared

Cleared

Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S 222020-248120, 240050-240980, 241130-246620, 4240420

K983495510(k) TraditionalCleared Dec 16, 199872-day reviewClass II21 CFR 888.3040

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

Syntec Scientific Corp. · HWC Screw, Fixation, Bone

Cleared on Dec 16, 1998 after a 72-day review. The FDA summary names its predicate without a number. 84 later devices descend from it.

Decided
Dec 16, 1998
Review
72 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
0

84 later devices descend from it, 11 citing it directly.

Descendants, by year cleared 2015: 7 descendants cleared2017: 3 descendants cleared2009: 2 descendants cleared2010: 2 descendants cleared2011: 3 descendants cleared2019: 6 descendants cleared2018: 4 descendants cleared2006: 1 descendant cleared2008: 3 descendants cleared2023: 8 descendants cleared2012: 2 descendants cleared2016: 3 descendants cleared2014: 3 descendants cleared2013: 1 descendant cleared2020: 6 descendants cleared2021: 7 descendants cleared2026: 7 descendants cleared2022: 4 descendants cleared2025: 5 descendants cleared2024: 7 descendants cleared1995200020052010201520202025
  1. This deviceK983495 Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S…Syntec 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 · cites it directly · 15 of its ownK170518 In2Bones Fracture and Correction SystemIn2bones USA, LLC · 2017 · Recalled
  5. Descendant · cites it directly · 14 of its ownK181113 CoLink™ Afx Plating SystemIn2bones USA, LLC · 2018
  6. Descendant · 2 generations on · 14 of its ownK092493 GPC Bone Plaes and Bone Screw & GPC DHS/DCS Plate SystemGpc Medical, Ltd. · 2010

Showing 5 of 84 descendants. See all descendants

Descendants cleared per year

2006: 12008: 32009: 22010: 22011: 32012: 22013: 12014: 32015: 72016: 32017: 32018: 42019: 62020: 62021: 72022: 42023: 82024: 72025: 52026: 7
2006high 8 (2023) · low 0 (2007)2026

Most influential descendants

Showing 5 of 84 · 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
  • K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC · 2017 · cites it directly15descendants
  • K181113CoLink™ Afx Plating SystemIn2bones USA, LLC · 2018 · cites it directly14descendants
  • K092493GPC Bone Plaes and Bone Screw & GPC DHS/DCS Plate SystemGpc Medical, Ltd. · 2010 · 2 generations on14descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K983495Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S…Syntec 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—
+1K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC20171
+1K181113CoLink™ Afx Plating SystemIn2bones USA, LLC2018—
+2K092493GPC Bone Plaes and Bone Screw & GPC DHS/DCS Plate SystemGpc Medical, Ltd.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200830
200920
201020
201130
201220
201310
201430
201570
201630
201730
201840
201960
202060
202170
202240
202380
202470
202550
202670
FIG. 1 — Lineage of K983495, 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 HWC? 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 HWC device

  1. #1 K203011 Monster Screw Systemscore 22.2 · 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? (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
*—Synthes bone plate and bone screw
Named without a submission number
—

What descends from it? (84)

See all 84

11 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
K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC201715
K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814
K092889Syntec Osteo-Plate and Screw FixationSyntec Scientific Corp.201013
K072411Aap Bone Plates and Screw ImplantsAap Implantate AG20089
K191009Arsenal Plating SystemTrilliant Surgical20192
K111432Evolve (R) Triad (TM) Plating System and Evolve (R) Triad (TM) Bone ScrewsWrightmedicaltechnologyinc20112
K150376Sonoma Cancellous Bone Screw and WasherSonoma Orthopedics Products, Inc.20150
K090839Modification to Syntec-Taichun Non-Sterile Bone Plate and Screw ImplantsSyntec Scientific Corp.20090

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 HWC devices

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

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

The bone plates and screws are provided non-sterile. The devices are intended to treat fractures of various bones, including the clavicle, scapula, pelvis, long bone (humerus, ulna, radius, femur, tibia, and fibula), and small bone (metacarpals, metatarsals, and phalanges).

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

Recent decisions in HWC

The HWC category page

  • K261961Ntegrate Threaded Nail SystemNvision Biomedical Technologies · 2026
  • K263116OsteoCentric Technologies Cannulated and Soild Fasteners with NutsOsteoCentric Technologies · 2026
  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K983495 · printed Nov 4, 2026

Cite this page

510(k) Report. “K983495: Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S 222020-248120, 240050-240980, 241130-246620, 4240420.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983495

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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