510(k) Report

510(k) · Cleared

Cleared

GPC Bone Plaes and Bone Screw & GPC DHS/DCS Plate System

K092493510(k) TraditionalCleared Mar 29, 2010227-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

Gpc Medical, Ltd. · HRS Plate, Fixation, Bone

Cleared on Mar 29, 2010 as substantially equivalent to K072562 (Microware Precision Co., Ltd., 2008) after a 227-day review. Its family tree reaches back 3 generations to 1998. 14 later devices descend from it.

Decided
Mar 29, 2010
Review
227 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K983495 (1998). 4 ancestors in all. 14 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor2015: 2 descendants cleared2011: 1 descendant cleared2016: 1 descendant cleared2017: 2 descendants cleared2014: 2 descendants cleared2025: 2 descendants cleared2024: 1 descendant cleared2020: 1 descendant cleared2026: 2 descendants clearedK983495 · Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S 222020-248120, 240050-240980, 241130-246620, 4240420 · Syntec Scientific Corp. · 1998K063020 · Intai Bone Plate and Bone Screw System; Intai DHS/DCS Plate System · Intai Technology, Inc. · 2006K072562 · Microware Bone Plates and Bone Screws · Microware Precision Co., Ltd. · 20081995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 6 descendants3 generations forward: 4 descendants K072562 · Microware Bone Plates and Bone Screws · Microware Precision Co., Ltd. · 2008K063020 · Intai Bone Plate and Bone Screw System; Intai DHS/DCS Plate System · Intai Technology, Inc. · 2006K983495 · Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S 222020-248120, 240050-240980, 241130-246620, 4240420 · Syntec Scientific Corp. · 19980
  1. Root · 3 generations backK983495 Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S…Syntec Scientific Corp. · 1998
  2. 2 generations backK063020 Intai Bone Plate and Bone Screw System; Intai DHS/DCS Plate SystemIntai Technology, Inc. · 2006
  3. 1 generation backK072562 Microware Bone Plates and Bone ScrewsMicroware Precision Co., Ltd. · 2008
  4. This deviceK092493 GPC Bone Plaes and Bone Screw & GPC DHS/DCS Plate SystemGpc Medical, Ltd. · 2010
  5. Descendant · cites it directly · 5 of its ownK110086 Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc. · 2011
  6. Descendant · cites it directly · 3 of its ownK161894 SurgTech Trauma SystemSurgtech, Inc. · 2017
  7. Descendant · 2 generations on · 2 of its ownK242939 ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024
  8. Descendant · cites it directly · 2 of its ownK143023 Nitinol Compression Plating SystemBiomedical Enterprises, Inc. · 2015
  9. Descendant · 2 generations on · 2 of its ownK130614 Bone Fragment and Fixation Plates, Screws and WashersLaura Cattabriga · 2014

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2011: 12014: 22015: 22016: 12017: 22020: 12024: 12025: 22026: 2
2011high 2 (2014) · low 0 (2012)2026

Most influential descendants

Showing 5 of 14 · See all
  • K110086Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc. · 2011 · cites it directly5descendants
  • K161894SurgTech Trauma SystemSurgtech, Inc. · 2017 · cites it directly3descendants
  • K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024 · 2 generations on2descendants
  • K143023Nitinol Compression Plating SystemBiomedical Enterprises, Inc. · 2015 · cites it directly2descendants
  • K130614Bone Fragment and Fixation Plates, Screws and WashersLaura Cattabriga · 2014 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K983495Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S…Syntec Scientific Corp.1998—
−2K063020Intai Bone Plate and Bone Screw System; Intai DHS/DCS Plate SystemIntai Technology, Inc.2006—
−1K072562Microware Bone Plates and Bone ScrewsMicroware Precision Co., Ltd.2008—
0 (this device)K092493GPC Bone Plaes and Bone Screw & GPC DHS/DCS Plate SystemGpc Medical, Ltd.2010—
+1K110086Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc.2011—
+1K161894SurgTech Trauma SystemSurgtech, Inc.2017—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical2024—
+1K143023Nitinol Compression Plating SystemBiomedical Enterprises, Inc.2015—
+2K130614Bone Fragment and Fixation Plates, Screws and WashersLaura Cattabriga2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201420
201520
201610
201720
202010
202410
202520
202620
FIG. 1 — Lineage of K092493, 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? (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
*K072562Microware Bone Plates and Bone Screws
Summary page 1
…tum district, Taichung Clty, 40763 Taiwan MICROWARE THE BONE PLATES AND BONE SCREW SYSTEM AND DHS/DCS PLATE SYSTEM 510k Number for M/s Microware Precision Co. Limited K072562 CONFIDENTIAL PAGE 1 OF 32 — et GPC Medical Ltd. (BAGKED BY EXPERISHEE STHEE 1930) 1SO 9001 1SO 13485 Certfied…
Microware Precision Co., Ltd.2008—

Also cleared against K072562: 2 other devices →

What descends from it? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K110086Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc.20115
K161894SurgTech Trauma SystemSurgtech, Inc.20173
K143023Nitinol Compression Plating SystemBiomedical Enterprises, Inc.20152
K153573ConvergeBiomedical Enterprises, Inc.20160

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?

  • The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K110086 (Internal Fixation Systems, Inc., 2011) has gone furthest, with 5 descendants of its own.
  • 2 other devices also cite its predicate K072562.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

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?

GPC BONE PLATES AND BONE SCREWS ARE PROVIDED NON-STERILE. GPC BONE PLATES AND SCREWS ARE INTENDED TO TREAT FRACTURES OF VARIOUS BONES, INCLUDING THE CLAVICLE, PELVIS, SCAPULA, LONG BONES(HUMERUS, RADIUS, ULNA, FEMUR, TIBIA AND FIBULA), AND SMALL BONES-LIKE METALCARPALS, METATARSALS AND PHALANGES.

GPC DHS/DCS PLATE SYSTEM IS PROVIDED NON-STERILE. THE GPC DHS/DCS PLAT SYSTEM IS INTENDED FOR USE IN FIXATION OF FRACTURES OF THE PROXIMAL FEMUR. THE GPC DHS/DCS PLATE SYSTEM IS INDICATED FOR USE IN TROCHANTERIC, PERTROCHANTERIC, INTERTROCHANTERIC AND BASILAR NECK FRACTURE

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

Also cleared against K072562

2 other devices cite the same predicate.

  • K171904Tandry Locking Plate SystemMicroware Precision Co., Ltd. · 2018
  • K111008Microware Bone Plates and Bone ScrewMicroware Precision Co., Ltd. · 2012

More from Gpc Medical, Ltd.

2 FDA decisions under this applicant name. See the company

  • K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd. · 2016

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/K092493 · printed Nov 6, 2026

Cite this page

510(k) Report. “K092493: GPC Bone Plaes and Bone Screw & GPC 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/K092493

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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