510(k) Report

510(k) · Cleared

Cleared

Fracture/Reconstruction System (Traumaone)

K081067510(k) SpecialCleared May 9, 200824-day reviewClass II21 CFR 872.4760

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biomet Microfixation, Inc. · JEY Plate, Bone

Cleared on May 9, 2008 as substantially equivalent to K001238 (Walter Lorenz Surgical, Inc., 2000) and 1 other predicate after a 24-day review. Its family tree reaches back 1 generation to 1998. 14 later devices descend from it.

Decided
May 9, 2008
Review
24 days
Class
Class II
Product code
JEY
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K980512 (1998). 2 ancestors in all. 14 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor2013: 1 descendant cleared2010: 1 descendant cleared2014: 1 descendant cleared2018: 1 descendant cleared2019: 3 descendants cleared2024: 3 descendants cleared2026: 4 descendants clearedK980512 · Lorenz Reconstruction System with Modular Screw · Walter Lorenz Surgical, Inc. · 19981995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 6 descendants4 generations forward: 4 descendants K980512 · Lorenz Reconstruction System with Modular Screw · Walter Lorenz Surgical, Inc. · 19980
  1. Root · 1 generation backK980512 Lorenz Reconstruction System with Modular ScrewWalter Lorenz Surgical, Inc. · 1998
  2. This deviceK081067 Fracture/Reconstruction System (Traumaone)Biomet Microfixation, Inc. · 2008
  3. Descendant · cites it directly · 12 of its ownK102641 Mini and Micro Fragments Reconstruction System-NeofaceNeoortho Produtos Ortopedicos S/A · 2010
  4. Descendant · 2 generations on · 8 of its ownK142419 Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A · 2014
  5. Descendant · 3 generations on · 4 of its ownK182718 Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda. · 2019
  6. Descendant · 3 generations on · 2 of its ownK242939 ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024
  7. Descendant · 3 generations on · 2 of its ownK242596 Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2024

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2010: 12013: 12014: 12018: 12019: 32024: 32026: 4
2010high 4 (2026) · low 0 (2011)2026

Most influential descendants

Showing 5 of 14 · See all
  • K102641Mini and Micro Fragments Reconstruction System-NeofaceNeoortho Produtos Ortopedicos S/A · 2010 · cites it directly12descendants
  • K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A · 2014 · 2 generations on8descendants
  • K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda. · 2019 · 3 generations on4descendants
  • K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024 · 3 generations on2descendants
  • K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2024 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K980512Lorenz Reconstruction System with Modular ScrewWalter Lorenz Surgical, Inc.1998—
0 (this device)K081067Fracture/Reconstruction System (Traumaone)Biomet Microfixation, Inc.2008—
+1K102641Mini and Micro Fragments Reconstruction System-NeofaceNeoortho Produtos Ortopedicos S/A2010—
+2K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A2014—
+3K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.2019—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical2024—
+3K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201310
201410
201810
201930
202430
202640
FIG. 1 — Lineage of K081067, 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 JEY? 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 JEY device

  1. #1 K252246 Leforte MMF Systemscore 15.6 · 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? (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
*K001238Lorenz Titanium Fracture / Reconstruction Plating System
Summary page 1
…lence Biomnet Microfixation considers the Fracture / Reconstructive Devices (TraumaOne) equivalent to the Lorenz Titanium Fracture / Reconstructive Devices cleared under K001238 and Lorenz Reconstruction System cleared under K9805 12.…
Walter Lorenz Surgical, Inc.20001
*K980512Lorenz Reconstruction System with Modular Screw
Summary page 1
…constructive Devices (TraumaOne) equivalent to the Lorenz Titanium Fracture / Reconstructive Devices cleared under K001238 and Lorenz Reconstruction System cleared under K9805 12. 51 ===…
Walter Lorenz Surgical, Inc.1998—

What descends from it? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K102641Mini and Micro Fragments Reconstruction System-NeofaceNeoortho Produtos Ortopedicos S/A201012
K131674Prebent Plating with Virtual Surgical PlanningBiomet Microfixation20130

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?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K102641 (Neoortho Produtos Ortopedicos S/A, 2010) has gone furthest, with 12 descendants of its own.

How does its category compare?

All JEY devices

JEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · JEY

2in 2025

2007: 92008: 72009: 42010: 62011: 52012: 102013: 82014: 62015: 72016: 12017: 52018: 72019: 62020: 62021: 42022: 52023: 22024: 52025: 22026 (partial year): 3
2007high 10 (2012) · low 1 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JEY

159in 2024

2007: 115 days median2008: 84 days median2009: 121 days median2010: 199 days median2011: 75 days median2012: 194 days median2013: 126 days median2014: 223 days median2015: 160 days median2017: 190 days median2018: 255 days median2019: 163 days median2020: 198 days median2021: 299 days median2022: 135 days median2024: 159 days median2026 (partial year): 258 days median
2007high 299 (2021) · low 75 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JEY

1in 2020

2008: 32009: 62010: 852013: 12020: 1
2007high 85 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JEY

1,003in 2025

2007: 292008: 242009: 932010: 2152011: 2412012: 4282013: 7662014: 6162015: 7672016: 5582017: 5682018: 6082019: 5952020: 6802021: 4512022: 3442023: 4952024: 6962025: 1,003
2007high 1,003 (2025) · low 24 (2008)2025

MAUDE reports naming product code JEY, 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
20079115029
2008784324
20094121693
2010619985215
20115750241
2012101940428
201381261766
201462230616
201571600767
20161—0558
201751900568
201872550608
201961630595
202061981680
202142990451
202251350344
20232—0495
202451590696
20252—01,003
202632580—

What is it indicated for?

Intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.

Indications for use as stated in the FDA summary.

More from Biomet Microfixation, Inc.

17 FDA decisions under this applicant name. See the company

  • P020016/S010Total Temporomandibular Joint Replacement SystemBiomet Microfixation, Inc. · 2026
  • P020016/S013Total Temporomandibular Joint Replacement SystemBiomet Microfixation, Inc. · 2026
  • P020016/S011Total Temporomandibular Joint Replacement SystemBiomet Microfixation, Inc. · 2019
  • P020016/S008Total Temporomandibular Joint (TMJ) Replacement SystemBiomet Microfixation, Inc. · 2017
  • P020016/S007Total Temporomandibular Joint Replacement SystemBiomet Microfixation, Inc. · 2014

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The JEY category page

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https://510kreport.com/device/K081067 · printed Nov 5, 2026

Cite this page

510(k) Report. “K081067: Fracture/Reconstruction System (Traumaone).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081067

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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