510(k) Report

510(k) · Cleared

Recalled · 2010

Lorenz 1.0MM, 1.5MM, 2.0MM System

K953385510(k) TraditionalCleared Sep 28, 199571-day reviewClass II21 CFR 872.4760Recalls 8

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 Sep 28, 1995 after a 71-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 25 later devices descend from it. It has been recalled 8 times.

Decided
Sep 28, 1995
Review
71 days
Class
Class II
Product code
JEY
Recalls
8
Predicates
0

25 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2003: 3 descendants cleared2012: 2 descendants cleared2001: 1 descendant cleared1997: 1 descendant cleared2007: 1 descendant cleared2013: 2 descendants cleared2016: 2 descendants cleared2010: 1 descendant cleared2019: 3 descendants cleared2015: 2 descendants cleared2014: 1 descendant cleared2025: 1 descendant cleared2022: 2 descendants cleared2018: 1 descendant cleared2020: 1 descendant cleared2023: 1 descendant cleared1995200020052010201520202025
  1. This deviceK953385 Lorenz 1.0MM, 1.5MM, 2.0MM SystemWalter Lorenz Surgical, Inc. · 1995
  2. Descendant · cites it directly · 5 of its ownK121624 Biomet Microfixation Neuro Plating SystemBiomet Microfixation · 2012 · Recalled
  3. Descendant · cites it directly · 5 of its ownK121589 Biomet Microfixation Facial Plating SystemBiomet Microfixation · 2012 · Recalled
  4. Descendant · cites it directly · 5 of its ownK031989 Ortrautek Orthognathic SystemTekka · 2003
  5. Descendant · 2 generations on · 4 of its ownK141911 Optimus Neuro SystemOsteonic Co., Ltd. · 2015
  6. Descendant · 2 generations on · 4 of its ownK091812 Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic…Frontier Devices, Inc. · 2010

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

1997: 12001: 12003: 32007: 12010: 12012: 22013: 22014: 12015: 22016: 22018: 12019: 32020: 12022: 22023: 12025: 1
1997high 3 (2003) · low 0 (1998)2026

Most influential descendants

Showing 5 of 25 · See all
  • K121624Biomet Microfixation Neuro Plating SystemBiomet Microfixation · 2012 · cites it directly5descendants
  • K121589Biomet Microfixation Facial Plating SystemBiomet Microfixation · 2012 · cites it directly5descendants
  • K031989Ortrautek Orthognathic SystemTekka · 2003 · cites it directly5descendants
  • K141911Optimus Neuro SystemOsteonic Co., Ltd. · 2015 · 2 generations on4descendants
  • K091812Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible…Frontier Devices, Inc. · 2010 · 2 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K953385Lorenz 1.0MM, 1.5MM, 2.0MM SystemWalter Lorenz Surgical, Inc.1995—
+1K121624Biomet Microfixation Neuro Plating SystemBiomet Microfixation20122
+1K121589Biomet Microfixation Facial Plating SystemBiomet Microfixation20121
+1K031989Ortrautek Orthognathic SystemTekka2003—
+2K141911Optimus Neuro SystemOsteonic Co., Ltd.2015—
+2K091812Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible…Frontier Devices, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200110
200330
200710
201010
201220
201320
201410
201520
201620
201810
201930
202010
202220
202310
202510
FIG. 1 — Lineage of K953385, 1995–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (25)

See all 25

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

NumberDeviceApplicantDecidedDescendants
K121624Biomet Microfixation Neuro Plating SystemBiomet Microfixation20125
K121589Biomet Microfixation Facial Plating SystemBiomet Microfixation20125
K031989Ortrautek Orthognathic SystemTekka20035
K010427Lorenz Fiducail ScrewWalter Lorenz Surgical, Inc.20011
K973484Chin DistractorHowmedica, Inc.19971
K122049Neuropro Low Profile Cranial Plating SystemKinamed, Inc.20130
K063386Lorenz Orthodontic Anchorage SystemWalter Lorenz Surgical, Inc.20070
K032520Ortrautek Trauma SystemTekka20030

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 8, 2010Not classifiedZ-0835-2012Mixed-up of materials/componentsOn 11/08/2010 Biomet Microfixation, Jacksonville, FL initiated a recall of the Biomet 1 count (REF 91-1504, Lot 622120) and 5 count (REF 95-1504, Lot 622120) packages of 1.5MM System High Torque (HT) Cross-Drive Screw 5/Pk and the Biomet…
Nov 8, 2010Not classifiedZ-0836-2012Mixed-up of materials/componentsOn 11/08/2010 Biomet Microfixation, Jacksonville, FL initiated a recall of the Biomet 1 count (REF 91-1504, Lot 622120) and 5 count (REF 95-1504, Lot 622120) packages of 1.5MM System High Torque (HT) Cross-Drive Screw 5/Pk and the Biomet…
Jul 28, 2010Not classifiedZ-2385-2011Labeling mix-upsBiomet Microfixation, Jacksonville, FL is recalling their 1.5 6 Hole Reg Double Y, Lots 785710, 753120, 693500 and 733600. This product is labeled as 01-7110-K (1.5 6 Hole Reg Double Y), however the package contains a 01-7112-K (1.5.6…
May 17, 2010Not classifiedZ-2873-2011Labeling mix-upsOn May 17, 2010, Biomet Microfixation issued a Safety Alert on their Thinflap System Cross Drive, Self Drilling Screw, 1.5x4mm, Model #: 91-6704, Lot#: 173770. The product is labeled incorrectly. Some packages of 91-6704 lot 173770 are…
Apr 26, 2010Not classifiedZ-1286-2012Error in labelingOn 4/26/10 Biomet Microfixation, Jacksonville, FL initiated a recall of their 1.5 3/3 hole 100 degree left X-long L plate, Model #01-7036, Lot #193690. Product is labeled incorrectly.
Mar 17, 2010Not classifiedZ-2206-2010OtherBiomet Microfixation has received a complaint from a customer who reports finding a 3.5mm length screw in one 5 pack of 4mm length screws.
Oct 6, 2009Not classifiedZ-1151-2010Process controlBiomet Microfixation is recalling Model 01-7293 an Model 99-7293-01, 1.5X3.5mm Self Drilling, Low Profile, Cross Drive screw, 5/PK was found to contain a 91-6104 (1.5X4mm High Torque, Self Drilling, Cross Drive screw.
Oct 5, 2009Not classifiedZ-1943-2010Process designBiomet Microfixation is recalling 91-6103 1.5x3.5mm HT SD X-drive screw Lot Number 829760. This package may contain 91-6704 1.5x4mm ThinFlap SD X-drive screw.

The 5 latest of 8 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K121624 (Biomet Microfixation, 2012) has gone furthest, with 5 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

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  • 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/K953385 · printed Nov 6, 2026

Cite this page

510(k) Report. “K953385: Lorenz 1.0MM, 1.5MM, 2.0MM System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953385

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