510(k) Report

510(k) · Cleared

Cleared

GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes, GPC 2.4mm Variable Angle Locking Two Column Volar Distal Radius Plates, 7 Head Holes, 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plate-Narrow, 6 Head Holes, Variable Angle Locking Screw 2.4 mm, Stardrive

K210198510(k) TraditionalCleared Jan 7, 2022347-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 Limited · HRS Plate, Fixation, Bone

Cleared on Jan 7, 2022 as substantially equivalent to K092556 (Synthes (Usa), 2009) and 1 other predicate after a 347-day review. Its family tree reaches back 4 generations to 1996.

Decided
Jan 7, 2022
Review
347 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K962616 (1996). 11 ancestors in all, the oldest K953644 (1996). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2009: 1 other ancestor2007: 1 other ancestor2003: 2 other ancestors1996: 2 other ancestors2001: 1 other ancestorReference device: K083694 · Synthes (Usa) 2.4 MM VA-LCP Two Column Volar Distal Radius Plates · Synthes (Usa) · 2009 · recalledK962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998K102694 · 2.4MM VA-LCP Dorsal Distal Radius Plates · Synthes (Usa) · 2010 · recalledK110125 · 2.4 MM VA-LCP Volar Rim Distal Radius System · Synthes USA · 2011199520002005201020152020
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors3 generations back: 2 other ancestors4 generations back: 1 other ancestor K110125 · 2.4 MM VA-LCP Volar Rim Distal Radius System · Synthes USA · 2011K102694 · 2.4MM VA-LCP Dorsal Distal Radius Plates · Synthes (Usa) · 2010 · recalledK982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998K962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 19960
  1. Root · 4 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 3 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 2 generations backK102694 2.4MM VA-LCP Dorsal Distal Radius PlatesSynthes (Usa) · 2010 · Recalled
  4. 1 generation backK110125 2.4 MM VA-LCP Volar Rim Distal Radius SystemSynthes USA · 2011
  5. This deviceK210198 GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius…Gpc Medical Limited · 2022
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−3K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−2K1026942.4MM VA-LCP Dorsal Distal Radius PlatesSynthes (Usa)20103
−1K1101252.4 MM VA-LCP Volar Rim Distal Radius SystemSynthes USA2011—
0 (this device)K210198GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6…Gpc Medical Limited2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
200110
200320
200710
200910
FIG. 1 — Lineage of K210198, 1996–2022Source: 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
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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
*K092556Synthes (Usa) 2.4MM VA-LCP Two-Column Narrow Volar Distal Radius
Summary page 5
…wing are the predicate device 510(k) with which we are declaring substantial equivalence: Primary predicate: Synthes (USA) 2.4mim VA-LCP Two-Column Narrow Volar Distal (K092556) Additional Predicate: Synthes 2.4mm Variable Angle LCR Volar Rim Distal Radius System (K110125) Reference Device: Synthes 2.4…
Synthes (Usa)20091
*K1101252.4 MM VA-LCP Volar Rim Distal Radius System
Summary page 5
…y predicate: Synthes (USA) 2.4mim VA-LCP Two-Column Narrow Volar Distal (K092556) Additional Predicate: Synthes 2.4mm Variable Angle LCR Volar Rim Distal Radius System (K110125) Reference Device: Synthes 2.4 mm VA-LCP Two-Column Volar Distal Radius Plate (K083694) A4). A description of the device that i…
Synthes USA2011—
†K083694Synthes (Usa) 2.4 MM VA-LCP Two Column Volar Distal Radius PlatesSynthes (Usa)20092

Also cleared against K092556: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 26 years and passes through 4 companies; a new generation was cleared every 10.7 years on median.
  • 4 of the 11 ancestors have a recall of any class.
  • 3 other devices also cite its predicate K092556.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Variable Angle Locking Two Column Volar Distal Radius Plating System is provided non-sterile.

GPC Variable Angle Locking Two Column Volar Distal Radius Plating System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.

The system is indicated for use in adult patients only. All implants are for single use only.

Indications for use as stated in the FDA summary.

Also cleared against K092556

3 other devices cite the same predicate.

  • K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) – MR…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2017
  • K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
  • K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A · 2014

More from Gpc Medical Limited

4 FDA decisions under this applicant name. See the company

  • K203811GPC Intraheal Intramedullary Nailing SystemGpc Medical Limited · 2022
  • K163096GPC BRAND Posterior, Non cervical Pedicle Screw Spinal SystemGpc Medical Limited · 2017
  • K143245GPC Intramedullary Nailing SystemsGpc Medical Limited · 2015

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/K210198 · printed Nov 6, 2026

Cite this page

510(k) Report. “K210198: GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes, GPC 2.4mm Variable Angle Locking Two Column Volar Distal Radius Plates, 7 Head Holes, 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plate-Narrow, 6 Head Holes, Variable Angle Locking Screw 2.4 mm, Stardrive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210198

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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