510(k) Report

510(k) · Cleared

Cleared

Mini and Micro Fragments Reconstruction System-NEOFIX

K142419510(k) TraditionalCleared Dec 16, 2014110-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

Neoortho Productos Orthopedicos S/A · HRS Plate, Fixation, Bone

Cleared on Dec 16, 2014 as substantially equivalent to K090047 (Synthes (Usa), 2009) and 10 other predicates after a 110-day review. Its family tree reaches back 6 generations to 1998. 8 later devices descend from it.

Decided
Dec 16, 2014
Review
110 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
11

Its longest line of descent runs back 6 generations to K981372 (1998). 63 ancestors in all, the oldest K882831 (1988). 8 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 3 other ancestors2009: 7 other ancestors2007: 4 other ancestors2006: 2 other ancestors2001: 5 other ancestors1998: 3 other ancestors2008: 3 other ancestors2005: 2 other ancestors2004: 4 other ancestors2003: 4 other ancestors2002: 2 other ancestors2000: 8 other ancestors1997: 1 other ancestor1996: 3 other ancestors1995: 1 other ancestor1991: 2 other ancestors1989: 1 other ancestor1999: 1 other ancestor1988: 1 other ancestor2019: 1 descendant cleared2024: 3 descendants cleared2026: 4 descendants clearedK981372 · Synthes 3.0 MM PC-Fix System · Synthes (Usa) · 1998K991407 · Synthes Locking Calcaneal Plates · Synthes (Usa) · 1999K033669 · Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) · Smith & Nephew, Inc. · 2003 · recalledK082807 · Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications · Synthes (Usa) · 2008K092609 · Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP) · Synthes (Usa) · 2009K113733 · Small and Large Fragments Osteosynthesis System Neofix · Neoortho Produtos Ortopedicos S/A · 20121990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 10 other ancestors2 generations back: 28 other ancestors3 generations back: 10 other ancestors4 generations back: 5 other ancestors5 generations back: 2 other ancestors6 generations back: 2 other ancestors 1 generation forward: 4 descendants2 generations forward: 4 descendants K113733 · Small and Large Fragments Osteosynthesis System Neofix · Neoortho Produtos Ortopedicos S/A · 2012K092609 · Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP) · Synthes (Usa) · 2009K082807 · Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications · Synthes (Usa) · 2008K033669 · Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) · Smith & Nephew, Inc. · 2003 · recalledK991407 · Synthes Locking Calcaneal Plates · Synthes (Usa) · 1999K981372 · Synthes 3.0 MM PC-Fix System · Synthes (Usa) · 1998−50
  1. Root · 6 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
  2. 5 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
  3. 4 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
  4. 3 generations backK082807 Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with…Synthes (Usa) · 2008
  5. 2 generations backK092609 Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking…Synthes (Usa) · 2009
  6. 1 generation backK113733 Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A · 2012
  7. This deviceK142419 Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A · 2014
  8. Descendant · cites it directly · 4 of its ownK182718 Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda. · 2019
  9. Descendant · cites it directly · 2 of its ownK242939 ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024
  10. Descendant · cites it directly · 2 of its ownK242596 Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2024
  11. Descendant · cites it directly · 1 of its ownK260390 Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026
  12. Descendant · 2 generations on · 0 of its ownK261830 FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate…Ortler Global Tibbi Gerecler Anonim Sirketi · 2026

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2019: 12024: 32026: 4
2019high 4 (2026) · low 0 (2020)2026

Most influential descendants

Showing 5 of 8 · See all
  • K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda. · 2019 · cites it directly4descendants
  • K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024 · cites it directly2descendants
  • K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2024 · cites it directly2descendants
  • K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026 · cites it directly1descendant
  • K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K981372Synthes 3.0 MM PC-Fix SystemSynthes (Usa)1998—
−5K991407Synthes Locking Calcaneal PlatesSynthes (Usa)1999—
−4K033669Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)Smith & Nephew, Inc.20031
−3K082807Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded…Synthes (Usa)2008—
−2K092609Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates…Synthes (Usa)2009—
−1K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A2012—
0 (this device)K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A2014—
+1K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.2019—
+1K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical2024—
+1K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.2024—
+1K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.2026—
+2K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System…Ortler Global Tibbi Gerecler Anonim Sirketi2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
198910
199120
199510
199630
199710
199830
199910
200080
200150
200220
200340
200440
200520
200620
200740
200830
200970
201030

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202430
202640
FIG. 1 — Lineage of K142419, 1998–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (11)

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
*K090047Synthes (Usa) 1.5MM Mini Fragment LCP System
Summary page 5
…regulation of medical devices, the subject device is substantially equivalent in indications and design principles to the following legally marketed predicate devices: K090047, Synthes (USA), Synthes (USA) 1.5 mm Mini Fragment LCP System K063049, Synthes (USA), Synthes (USA) Modular Mini Fragment LCP Sy…
Synthes (Usa)2009—
*K063049Synthes (Usa) Modular Mini Fragment LCP System
Summary page 5
…ivalent in indications and design principles to the following legally marketed predicate devices: K090047, Synthes (USA), Synthes (USA) 1.5 mm Mini Fragment LCP System K063049, Synthes (USA), Synthes (USA) Modular Mini Fragment LCP System…
Synthes (Usa)20064
*K1026942.4MM VA-LCP Dorsal Distal Radius Plates
Summary page 6
…Mini and Micro Fragments Reconstruction System – NEOFIX K142419 K102694, Synthes (USA), Synthes (USA) 2.4 mm Variable Angle LCP Dorsal Distal Radius Plates K071184, Synthes (USA), Synthes Variable An…
Synthes (Usa)20103
*K071184Synthes (Usa) Variable Angle-Locking Compression Plate (VA-LCP) Distal Radius System
Summary page 6
…K142419 K102694, Synthes (USA), Synthes (USA) 2.4 mm Variable Angle LCP Dorsal Distal Radius Plates K071184, Synthes (USA), Synthes Variable Angle-locking Compression Plate (VA-LCP) Distal Radius System K083694, Synthes (USA), Synthes…
Synthes (Usa)20071
*K083694Synthes (Usa) 2.4 MM VA-LCP Two Column Volar Distal Radius Plates
Summary page 6
…es (USA) 2.4 mm Variable Angle LCP Dorsal Distal Radius Plates K071184, Synthes (USA), Synthes Variable Angle-locking Compression Plate (VA-LCP) Distal Radius System K083694, Synthes (USA), Synthes 2.4 mm VA-LCP Two-Column Volar Distal Radius Plates K091644, Synthes (USA), Synthes (USA) 2.4 mm LCP Vol…
Synthes (Usa)20092
*K091644Synthes (Usa) 2.4MM LCP Volar Column Distal Radius Plates
Summary page 6
…A), Synthes Variable Angle-locking Compression Plate (VA-LCP) Distal Radius System K083694, Synthes (USA), Synthes 2.4 mm VA-LCP Two-Column Volar Distal Radius Plates K091644, Synthes (USA), Synthes (USA) 2.4 mm LCP Volar Column Distal Radius Plates K092556, Synthes (USA) 2.4 mm VA-LCP Two-Column Narro…
Synthes (Usa)2009—
*K092556Synthes (Usa) 2.4MM VA-LCP Two-Column Narrow Volar Distal Radius
Summary page 6
…K083694, Synthes (USA), Synthes 2.4 mm VA-LCP Two-Column Volar Distal Radius Plates K091644, Synthes (USA), Synthes (USA) 2.4 mm LCP Volar Column Distal Radius Plates K092556, Synthes (USA) 2.4 mm VA-LCP Two-Column Narrow Volar Distal Radius Plates K012114, Synthes (USA), Synthes Locking Distal Radius…
Synthes (Usa)20091
*K012114Synthes Locking Distal Radius Plating System
Summary page 6
…s K091644, Synthes (USA), Synthes (USA) 2.4 mm LCP Volar Column Distal Radius Plates K092556, Synthes (USA) 2.4 mm VA-LCP Two-Column Narrow Volar Distal Radius Plates K012114, Synthes (USA), Synthes Locking Distal Radius Plating System K102641, NEOORTHO Produtos Ortopédicos S/A, Mini and Micro Fragment…
Synthes (Usa)20013
*K102641Mini and Micro Fragments Reconstruction System-Neoface
Summary page 6
…l Radius Plates K092556, Synthes (USA) 2.4 mm VA-LCP Two-Column Narrow Volar Distal Radius Plates K012114, Synthes (USA), Synthes Locking Distal Radius Plating System K102641, NEOORTHO Produtos Ortopédicos S/A, Mini and Micro Fragments Reconstruction System – NEOFACE K982732, Synthes (USA), Synthes (U…
Neoortho Produtos Ortopedicos S/A2010—
*K982732Synthes (Usa) Distal Radius Plate System (DRPS)
Summary page 6
…2114, Synthes (USA), Synthes Locking Distal Radius Plating System K102641, NEOORTHO Produtos Ortopédicos S/A, Mini and Micro Fragments Reconstruction System – NEOFACE K982732, Synthes (USA), Synthes (USA) Distal Radius Plate System K113733, NEOORTHO Produtos Ortopédicos S/A, Small and Large Fragments…
Synthes1998—
*K113733Small and Large Fragments Osteosynthesis System Neofix
Summary page 6
…K102641, NEOORTHO Produtos Ortopédicos S/A, Mini and Micro Fragments Reconstruction System – NEOFACE K982732, Synthes (USA), Synthes (USA) Distal Radius Plate System K113733, NEOORTHO Produtos Ortopédicos S/A, Small and Large Fragments Osteosynthesis System NEOFIX The subject device and the predicate…
Neoortho Produtos Ortopedicos S/A2012—

Also cleared against K090047: 17 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194
K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242
K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242
K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261

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 16 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
  • 21 of the 63 ancestors have a recall of any class.
  • Of its descendants, K182718 (Gm Dos Reis Industria E Comerico Ltda., 2019) has gone furthest, with 4 descendants of its own.
  • 17 other devices also cite its predicate K090047.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?

Mini and Micro Fragments Reconstruction System – NEOFIX is intended for small bone fracture fixation, arthrodesis, reconstruction, and osteotomy fixation. Examples include small bones of the hand, wrist, foot and ankle. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone.

Indications for use as stated in the FDA summary.

Also cleared against K090047

17 other devices cite the same predicate.

  • K242973CanMINI Hand and Foot SystemCanwell Medical Co., Ltd. · 2025
  • K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company · 2024
  • K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd. · 2023
  • K193345Arthrex DynaNite Compression PlateArthrex, Inc. · 2020
  • K190391TDM Plate and Screw SystemsTdm Co., Ltd. · 2019
  • K181843MLP Special Locking Bone Plate SystemMaxxion Medical, LLC / Baumer SA · 2019

More from Neoortho Productos Orthopedicos S/A

2 FDA decisions under this applicant name. See the company

  • K132653Neoplate Spine Anterior Fixation SystemNeoortho Productos Orthopedicos S/A · 2014

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/K142419 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142419: Mini and Micro Fragments Reconstruction System-NEOFIX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142419

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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