510(k) Report

510(k) · Cleared

Cleared

Synthes Stainless Steel Modular Hand System

K030310510(k) TraditionalCleared Apr 22, 200382-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

Synthes (Usa) · HRS Plate, Fixation, Bone

Cleared on Apr 22, 2003 after an 82-day review. The FDA summary names no predicate by number. 151 later devices descend from it.

Decided
Apr 22, 2003
Review
82 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
0

151 later devices descend from it, 16 citing it directly.

Descendants, by year cleared 2020: 11 descendants cleared2019: 10 descendants cleared2011: 3 descendants cleared2009: 2 descendants cleared2014: 5 descendants cleared2021: 14 descendants cleared2015: 9 descendants cleared2005: 1 descendant cleared2017: 8 descendants cleared2006: 1 descendant cleared2025: 12 descendants cleared2013: 3 descendants cleared2026: 22 descendants cleared2012: 4 descendants cleared2018: 5 descendants cleared2022: 10 descendants cleared2016: 5 descendants cleared2024: 18 descendants cleared2023: 8 descendants cleared200020052010201520202025
  1. This deviceK030310 Synthes Stainless Steel Modular Hand SystemSynthes (Usa) · 2003
  2. Descendant · cites it directly · 118 of its ownK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
  3. Descendant · 2 generations on · 44 of its ownK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
  4. Descendant · 2 generations on · 33 of its ownK161616 DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm…Synthes USA Products, LLC · 2017
  5. Descendant · 3 generations on · 23 of its ownK143385 Acumed Ankle Plating SystemAcumed, LLC · 2015
  6. Descendant · 4 generations on · 15 of its ownK151886 Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC · 2015

Showing 5 of 151 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12009: 22011: 32012: 42013: 32014: 52015: 92016: 52017: 82018: 52019: 102020: 112021: 142022: 102023: 82024: 182025: 122026: 22
2005high 22 (2026) · low 0 (2007)2026

Most influential descendants

Showing 5 of 151 · See all
  • K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011 · cites it directly118descendants
  • K120854Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012 · 2 generations on44descendants
  • K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC · 2017 · 2 generations on33descendants
  • K143385Acumed Ankle Plating SystemAcumed, LLC · 2015 · 3 generations on23descendants
  • K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC · 2015 · 4 generations on15descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K030310Synthes Stainless Steel Modular Hand SystemSynthes (Usa)2003—
+1K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011—
+2K120854Synthes VA LCP Ankle Trauma SystemSynthes USA2012—
+2K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated…Synthes USA Products, LLC2017—
+3K143385Acumed Ankle Plating SystemAcumed, LLC2015—
+4K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200920
201130
201240
201330
201450
201590
201650
201780
201850
2019100
2020110
2021140
2022100
202380
2024180
2025120
2026220
FIG. 1 — Lineage of K030310, 2003–2026Source: 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?

The FDA summary names no predicate by number.

What descends from it? (151)

See all 151

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

NumberDeviceApplicantDecidedDescendants
K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011118
K090522Osteomed Hand Plate and Screw Fixation SystemOsteomed LP200915
K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Synthes (USA) Products, LLC201514
K043263Trimed Osteotomy PlateTriMed, Inc.200511
K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157
K1101252.4 MM VA-LCP Volar Rim Distal Radius SystemSynthes USA20115
K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191
K182650Arzzt Distal Radius and Ulna SystemTruemed Group, LLC20191
K111419Osteomed Hand Fusion SystemOsteomed LP20111
K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210

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, K112583 (Synthes (USA) Products, LLC, 2011) has gone furthest, with 118 descendants of its own.

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 Synthes Stainless Steel Modular Hand System consists of plates and screws intended for use in selective trauma, reconstructive procedures, and general surgery of the hand, wrist, and other small bones.

Indications for use as stated in the FDA summary.

More from Synthes (Usa)

406 FDA decisions under this applicant name. See the company

  • K131984Synthes Synsonic Ulna NailSynthes (Usa) · 2014
  • K111667Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 20111 recall
  • K111540Synthes 3.5MM LCP Clavicle Plate SystemSynthes (Usa) · 2011
  • K110789Synthes Sternal Zipfix SystemSynthes (Usa) · 20113 recalls
  • K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) · 20112 recalls

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/K030310 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030310: Synthes Stainless Steel Modular Hand System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030310

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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