510(k) Report

510(k) · Cleared

Cleared

Synthes Calcaneal Plate

K020401510(k) TraditionalCleared May 8, 200290-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 May 8, 2002 after a 90-day review. The FDA summary names no predicate by number. 132 later devices descend from it.

Decided
May 8, 2002
Review
90 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
0

132 later devices descend from it, 12 citing it directly.

Descendants, by year cleared 2014: 11 descendants cleared2011: 2 descendants cleared2018: 5 descendants cleared2002: 1 descendant cleared2012: 3 descendants cleared2021: 12 descendants cleared2004: 2 descendants cleared2025: 11 descendants cleared2006: 2 descendants cleared2007: 4 descendants cleared2008: 1 descendant cleared2009: 1 descendant cleared2015: 2 descendants cleared2020: 9 descendants cleared2022: 5 descendants cleared2019: 7 descendants cleared2024: 12 descendants cleared2017: 9 descendants cleared2026: 14 descendants cleared2010: 1 descendant cleared2013: 2 descendants cleared2023: 15 descendants cleared2016: 1 descendant cleared200020052010201520202025
  1. This deviceK020401 Synthes Calcaneal PlateSynthes (Usa) · 2002
  2. Descendant · cites it directly · 98 of its ownK033639 Acumed Lower Extremity Congruent Plate SystemAcumed, LLC · 2004 · Recalled
  3. Descendant · 2 generations on · 73 of its ownK073375 Newdeal Tibiaxys SystemNewdeal Sas · 2008 · Recalled
  4. Descendant · 3 generations on · 69 of its ownK110670 VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc…Smith & Nephew, Inc. · 2011
  5. Descendant · 3 generations on · 56 of its ownK100176 Ascension Ankle Fusion Plate SystemAscension Orthopedics, Inc. · 2010
  6. Descendant · 3 generations on · 53 of its ownK121425 Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc · 2012

Showing 5 of 132 descendants. See all descendants

Descendants cleared per year

2002: 12004: 22006: 22007: 42008: 12009: 12010: 12011: 22012: 32013: 22014: 112015: 22016: 12017: 92018: 52019: 72020: 92021: 122022: 52023: 152024: 122025: 112026: 14
2002high 15 (2023) · low 0 (2003)2026

Most influential descendants

Showing 5 of 132 · See all
  • K033639Acumed Lower Extremity Congruent Plate SystemAcumed, LLC · 2004 · cites it directly98descendants
  • K073375Newdeal Tibiaxys SystemNewdeal Sas · 2008 · 2 generations on73descendants
  • K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc. · 2011 · 3 generations on69descendants
  • K100176Ascension Ankle Fusion Plate SystemAscension Orthopedics, Inc. · 2010 · 3 generations on56descendants
  • K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc · 2012 · 3 generations on53descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K020401Synthes Calcaneal PlateSynthes (Usa)2002—
+1K033639Acumed Lower Extremity Congruent Plate SystemAcumed, LLC200410
+2K073375Newdeal Tibiaxys SystemNewdeal Sas20082
+3K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone…Smith & Nephew, Inc.2011—
+3K100176Ascension Ankle Fusion Plate SystemAscension Orthopedics, Inc.2010—
+3K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200420
200620
200740
200810
200910
201010
201120
201230
201320
2014110
201520
201610
201790
201850
201970
202090
2021120
202250
2023150
2024120
2025110
2026140
FIG. 1 — Lineage of K020401, 2002–2026Source: 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? (132)

See all 132

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

NumberDeviceApplicantDecidedDescendants
K033639Acumed Lower Extremity Congruent Plate SystemAcumed, LLC200498
K041786Calcamea PlateNew Deal, S.A.200413
K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A201211
K171808TDM Plate and Screw SystemTdm Co., Ltd.20186
K110086Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc.20115
K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182
K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210
K142579Zimmer Periarticular Plating SystemZimmer, Inc.20140
K141517Zimmer Plates and Screws (ZPS)-Non-Sterile PlatesZimmer, Inc.20140
K133536Emerge Medical Bone Plate SystemEmerge Medical20140

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, K033639 (Acumed, LLC, 2004) has gone furthest, with 98 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 Calcaneal Plate is intended for fixation of complex extra-articular and intra-articular fractures and osteotomies of the calcaneus.

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

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/K020401 · printed Nov 5, 2026

Cite this page

510(k) Report. “K020401: Synthes Calcaneal Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020401

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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