510(k) Report

510(k) · Cleared

Recalled · 2008

Lorenz Titanium Fracture / Reconstruction Plating System

K001238510(k) SpecialCleared May 3, 200015-day reviewClass II21 CFR 872.4760Recalls 1

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 3, 2000 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 15 later devices descend from it. It has been recalled once.

Decided
May 3, 2000
Review
15 days
Class
Class II
Product code
JEY
Recalls
1
Predicates
0

15 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared2013: 1 descendant cleared2010: 1 descendant cleared2014: 1 descendant cleared2018: 1 descendant cleared2019: 3 descendants cleared2024: 3 descendants cleared2026: 4 descendants cleared200020052010201520202025
  1. This deviceK001238 Lorenz Titanium Fracture / Reconstruction Plating SystemWalter Lorenz Surgical, Inc. · 2000
  2. Descendant · cites it directly · 14 of its ownK081067 Fracture/Reconstruction System (Traumaone)Biomet Microfixation, Inc. · 2008
  3. Descendant · 2 generations on · 12 of its ownK102641 Mini and Micro Fragments Reconstruction System-NeofaceNeoortho Produtos Ortopedicos S/A · 2010
  4. Descendant · 3 generations on · 8 of its ownK142419 Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A · 2014
  5. Descendant · 4 generations on · 4 of its ownK182718 Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda. · 2019
  6. Descendant · 4 generations on · 2 of its ownK242939 ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2008: 12010: 12013: 12014: 12018: 12019: 32024: 32026: 4
2008high 4 (2026) · low 0 (2009)2026

Most influential descendants

Showing 5 of 15 · See all
  • 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
  • K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001238Lorenz Titanium Fracture / Reconstruction Plating SystemWalter Lorenz Surgical, Inc.2000—
+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—
+4K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201010
201310
201410
201810
201930
202430
202640
FIG. 1 — Lineage of K001238, 2000–2026Source: 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), 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?

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

What descends from it? (15)

See all 15

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K081067Fracture/Reconstruction System (Traumaone)Biomet Microfixation, Inc.200814

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 11, 2008Not classifiedZ-0282-2009Labeling mix-upsThe packaging for the 91-2416, 2.4X16MM HT X-DRIVE SCREW, Lot 493200 actually contained the 99-6577, 2.0X7MM FOSSA X-DRIVE SCREW.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K081067 (Biomet Microfixation, Inc., 2008) has gone furthest, with 14 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—

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

Recent decisions in JEY

The JEY category page

  • K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual…KLS-Martin L.P. · 2026
  • K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd. · 2026
  • K252246Leforte MMF SystemJeil Medical Corporation · 2026
  • K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty), Ltd. · 2025
  • 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/K001238 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001238: Lorenz Titanium Fracture / Reconstruction Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001238

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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