510(k) Report

510(k) · Cleared

Cleared

Lorenz Reconstruction System with Modular Screw

K980512510(k) TraditionalCleared May 11, 199890-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

Walter Lorenz Surgical, Inc. · JEY Plate, Bone

Cleared on May 11, 1998 after a 90-day review. The FDA summary names its predicate without a number. 18 later devices descend from it.

Decided
May 11, 1998
Review
90 days
Class
Class II
Product code
JEY
Recalls
None
Predicates
0

18 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2008: 2 descendants cleared2007: 1 descendant cleared2013: 1 descendant cleared2010: 1 descendant cleared2015: 1 descendant cleared2019: 3 descendants cleared2014: 1 descendant cleared2018: 1 descendant cleared2024: 3 descendants cleared2026: 4 descendants cleared1995200020052010201520202025
  1. This deviceK980512 Lorenz Reconstruction System with Modular ScrewWalter Lorenz Surgical, Inc. · 1998
  2. Descendant · cites it directly · 16 of its ownK063052 Lorenz Titanium Fracture / Reconstruction Devices and Pre-Bent PlatesWalter Lorenz Surgical, Inc. · 2007
  3. Descendant · cites it directly · 14 of its ownK081067 Fracture/Reconstruction System (Traumaone)Biomet Microfixation, Inc. · 2008
  4. Descendant · 2 generations on · 12 of its ownK102641 Mini and Micro Fragments Reconstruction System-NeofaceNeoortho Produtos Ortopedicos S/A · 2010
  5. Descendant · 3 generations on · 8 of its ownK142419 Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A · 2014
  6. Descendant · 4 generations on · 4 of its ownK182718 Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda. · 2019

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2007: 12008: 22010: 12013: 12014: 12015: 12018: 12019: 32024: 32026: 4
2007high 4 (2026) · low 0 (2009)2026

Most influential descendants

Showing 5 of 18 · See all
  • K063052Lorenz Titanium Fracture / Reconstruction Devices and Pre-Bent PlatesWalter Lorenz Surgical, Inc. · 2007 · cites it directly16descendants
  • K081067Fracture/Reconstruction System (Traumaone)Biomet Microfixation, Inc. · 2008 · cites it directly14descendants
  • K102641Mini and Micro Fragments Reconstruction System-NeofaceNeoortho Produtos Ortopedicos S/A · 2010 · 2 generations on12descendants
  • K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A · 2014 · 3 generations on8descendants
  • K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda. · 2019 · 4 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K980512Lorenz Reconstruction System with Modular ScrewWalter Lorenz Surgical, Inc.1998—
+1K063052Lorenz Titanium Fracture / Reconstruction Devices and Pre-Bent PlatesWalter Lorenz Surgical, Inc.2007—
+1K081067Fracture/Reconstruction System (Traumaone)Biomet Microfixation, Inc.2008—
+2K102641Mini and Micro Fragments Reconstruction System-NeofaceNeoortho Produtos Ortopedicos S/A2010—
+3K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A2014—
+4K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200820
201010
201310
201410
201510
201810
201930
202430
202640
FIG. 1 — Lineage of K980512, 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
*—Synthes Maxillofacial's Mandibular Modular Fixation System
Named without a submission number
—
*—Leibinger's Locking Screw Mandibular Reconstruction Plating System
Named without a submission number
—

What descends from it? (18)

See all 18

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

NumberDeviceApplicantDecidedDescendants
K063052Lorenz Titanium Fracture / Reconstruction Devices and Pre-Bent PlatesWalter Lorenz Surgical, Inc.200716
K081067Fracture/Reconstruction System (Traumaone)Biomet Microfixation, Inc.200814

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, K063052 (Walter Lorenz Surgical, Inc., 2007) has gone furthest, with 16 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.

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?

The Lorenz Reconstruction System with Modular Screw is intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.

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

More from Walter Lorenz Surgical, Inc.

56 FDA decisions under this applicant name. See the company

  • K063386Lorenz Orthodontic Anchorage SystemWalter Lorenz Surgical, Inc. · 2007
  • K063052Lorenz Titanium Fracture / Reconstruction Devices and Pre-Bent PlatesWalter Lorenz Surgical, Inc. · 2007
  • K063506Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2006
  • K062842Twist DrillWalter Lorenz Surgical, Inc. · 20061 recall
  • K061384Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer, TitaniumWalter Lorenz Surgical, Inc. · 2006

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The JEY category page

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  • K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OY · 2025

https://510kreport.com/device/K980512 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980512: Lorenz Reconstruction System with Modular Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980512

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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