510(k) Report

510(k) · Cleared

Recalled · 2010

Wuerzburg Titanium Mini Bone Plates & Bone Screws

K854886510(k) TraditionalCleared Jan 21, 198646-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 Jan 21, 1986 after a 46-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 241 later devices descend from it. It has been recalled once.

Decided
Jan 21, 1986
Review
46 days
Class
Class II
Product code
JEY
Recalls
1
Predicates
0

241 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 2003: 8 descendants cleared2006: 5 descendants cleared1997: 4 descendants cleared2012: 12 descendants cleared1996: 1 descendant cleared2002: 6 descendants cleared2005: 2 descendants cleared2017: 7 descendants cleared2007: 5 descendants cleared2022: 12 descendants cleared2010: 8 descendants cleared2016: 13 descendants cleared2004: 2 descendants cleared2008: 4 descendants cleared2019: 9 descendants cleared2015: 13 descendants cleared2013: 9 descendants cleared2001: 1 descendant cleared1998: 2 descendants cleared2009: 3 descendants cleared2023: 16 descendants cleared2018: 13 descendants cleared2026: 18 descendants cleared2014: 9 descendants cleared2025: 17 descendants cleared2024: 25 descendants cleared1999: 2 descendants cleared2011: 5 descendants cleared2020: 5 descendants cleared2021: 5 descendants cleared1990200020102020
  1. This deviceK854886 Wuerzburg Titanium Mini Bone Plates & Bone ScrewsWalter Lorenz Surgical, Inc. · 1986
  2. Descendant · cites it directly · 188 of its ownK963741 Leibinger Luhr Small Craniomaxillofacial Bone ScrewsHowmedica Leibinger, Inc. · 1997
  3. Descendant · cites it directly · 144 of its ownK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
  4. Descendant · 2 generations on · 143 of its ownK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
  5. Descendant · 3 generations on · 141 of its ownK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
  6. Descendant · 4 generations on · 117 of its ownK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002

Showing 5 of 241 descendants. See all descendants

Descendants cleared per year

1996: 11997: 41998: 21999: 22001: 12002: 62003: 82004: 22005: 22006: 52007: 52008: 42009: 32010: 82011: 52012: 122013: 92014: 92015: 132016: 132017: 72018: 132019: 92020: 52021: 52022: 122023: 162024: 252025: 172026: 18
1996high 25 (2024) · low 0 (2000)2026

Most influential descendants

Showing 5 of 241 · See all
  • K963741Leibinger Luhr Small Craniomaxillofacial Bone ScrewsHowmedica Leibinger, Inc. · 1997 · cites it directly188descendants
  • K963739Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997 · cites it directly144descendants
  • K970912Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997 · 2 generations on143descendants
  • K974785Auto-Drive Bone ScrewOsteomed Corp. · 1998 · 3 generations on141descendants
  • K013954Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002 · 4 generations on117descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K854886Wuerzburg Titanium Mini Bone Plates & Bone ScrewsWalter Lorenz Surgical, Inc.1986—
+1K963741Leibinger Luhr Small Craniomaxillofacial Bone ScrewsHowmedica Leibinger, Inc.1997—
+1K963739Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc.1997—
+2K970912Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc.1997—
+3K974785Auto-Drive Bone ScrewOsteomed Corp.1998—
+4K013954Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199740
199820
199920
200110
200260
200380
200420
200520
200650
200750
200840
200930
201080
201150
2012120
201390
201490
2015130
2016130
201770
2018130
201990
202050
202150
2022120
2023160
2024250
2025170
2026180
FIG. 1 — Lineage of K854886, 1986–2026Source: 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? (241)

See all 241

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

NumberDeviceApplicantDecidedDescendants
K963741Leibinger Luhr Small Craniomaxillofacial Bone ScrewsHowmedica Leibinger, Inc.1997188
K963739Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc.1997144
K022185Universal CMF SystemStryker Instruments200233
K961120Marker System for Stereotaxic NavigationHowmedica Leibinger, Inc.199617
K021684The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20027
K121624Biomet Microfixation Neuro Plating SystemBiomet Microfixation20125
K121589Biomet Microfixation Facial Plating SystemBiomet Microfixation20125
K031989Ortrautek Orthognathic SystemTekka20035
K062819Bioplate Rigid Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20063
K032520Ortrautek Trauma SystemTekka20030

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

Recalls of this device

DateClassRecallRoot causeReason
Aug 31, 2010Not classifiedZ-0108-2011OtherMislabeled size: The 2.0/1.0 4 hole long plate, Lot 120150 is labeled as 01-9205 (2.0/1.0 4 Hole Long Plate), however, the package contains a 01-9204 (2.0/1.0 4 Hole Regular Plate).

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K963741 (Howmedica Leibinger, Inc., 1997) has gone furthest, with 188 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/K854886 · printed Nov 4, 2026

Cite this page

510(k) Report. “K854886: Wuerzburg Titanium Mini Bone Plates & Bone Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K854886

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