510(k) Report

510(k) · Cleared

Cleared

Mondeal Extremity Bone Fixation System

K072740510(k) TraditionalCleared Nov 19, 200753-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

Mondeal Medical Systems GmbH · HRS Plate, Fixation, Bone

Cleared on Nov 19, 2007 after a 53-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 24 later devices descend from it.

Decided
Nov 19, 2007
Review
53 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
0

24 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2017: 2 descendants cleared2025: 4 descendants cleared2020: 3 descendants cleared2024: 4 descendants cleared2019: 1 descendant cleared2023: 6 descendants cleared2021: 2 descendants cleared2026: 2 descendants cleared20052010201520202025
  1. This deviceK072740 Mondeal Extremity Bone Fixation SystemMondeal Medical Systems GmbH · 2007
  2. Descendant · cites it directly · 19 of its ownK162674 BioPro Foot Plating SystemsBiopro, Inc. · 2017
  3. Descendant · 2 generations on · 11 of its ownK193222 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2020
  4. Descendant · 3 generations on · 10 of its ownK203817 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2021
  5. Descendant · 3 generations on · 9 of its ownK222465 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2023
  6. Descendant · 2 generations on · 5 of its ownK183011 Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics · 2019

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2017: 22019: 12020: 32021: 22023: 62024: 42025: 42026: 2
2017high 6 (2023) · low 0 (2018)2026

Most influential descendants

Showing 5 of 24 · See all
  • K162674BioPro Foot Plating SystemsBiopro, Inc. · 2017 · cites it directly19descendants
  • K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2020 · 2 generations on11descendants
  • K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2021 · 3 generations on10descendants
  • K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2023 · 3 generations on9descendants
  • K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics · 2019 · 2 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K072740Mondeal Extremity Bone Fixation SystemMondeal Medical Systems GmbH2007—
+1K162674BioPro Foot Plating SystemsBiopro, Inc.2017—
+2K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC2020—
+3K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC2021—
+3K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC2023—
+2K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201720
201910
202030
202120
202360
202440
202540
202620
FIG. 1 — Lineage of K072740, 2007–2026Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (24)

See all 24

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

NumberDeviceApplicantDecidedDescendants
K162674BioPro Foot Plating SystemsBiopro, Inc.201719
K192696TriMed ASET Foot Plating SystemTriMed, Inc.20201
K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System…TriMed, Inc.20250
K233863TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating…TriMed, Inc.20240
K162154Pantheon Medical Balanced Plating SystemPantheon Medical20170

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, K162674 (Biopro, Inc., 2017) has gone furthest, with 19 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. 2007, 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—

More from Mondeal Medical Systems GmbH

6 FDA decisions under this applicant name. See the company

  • K071798Mondeal Distal Radius SystemMondeal Medical Systems GmbH · 2007
  • K071797Mondeal Hand Contour SystemMondeal Medical Systems GmbH · 2007
  • K062436Sis Sinus Implant StabilizerMondeal Medical Systems GmbH · 2007
  • K050257Lin/Liou Orthodontic Mini Anchor System (Lomas) (Sterile)Mondeal Medical Systems GmbH · 2005
  • K042345Lin/Liou Orthodontic Mini Anchor System (Lomas)Mondeal Medical Systems GmbH · 2005

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/K072740 · printed Nov 4, 2026

Cite this page

510(k) Report. “K072740: Mondeal Extremity Bone Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072740

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026