510(k) Report

FDA applicant

Walter Lorenz Surgical, Inc.

Jacksonville, FL56 decisions1986–200722 recalls

FDA records 56 decisions for Walter Lorenz Surgical, Inc. (Jacksonville, FL) from 1986 to 2007: 56 510(k) clearances. Most are in product codes JEY (Plate, Bone) and MQN (External Mandibular Fixator And/Or Distractor). Its devices cite 52 predicates, 23 of them its own earlier devices. 22 recalls are linked to its devices.

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

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Walter Lorenz Surgical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

2in 2020

2008: 12009: 32010: 72018: 62020: 2
2007high 7 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Walter Lorenz Surgical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Walter Lorenz Surgical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • JEYPlate, Bone15decisions
  • MQNExternal Mandibular Fixator And/Or Distractor6decisions
  • HRSPlate, Fixation, Bone6decisions
  • HWCScrew, Fixation, Bone4decisions
  • DZLScrew, Fixation, Intraosseous2decisions
  • GXNPlate, Cranioplasty, Preformed, Non-Alterable2decisions

Also: NEU (2), HAW (2), LYA (1), GCX (1), HBE (1), GCT (1).

Whose devices does it build on?

Its devices cite 52 predicates; 23 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 127 times; 23 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K854886Wuerzburg Titanium Mini Bone Plates & Bone ScrewsWalter Lorenz Surgical, Inc. · 198610cite it
  • K011076Lorenz Sternal Closure System with Modular ScrewWalter Lorenz Surgical, Inc. · 20019cite it
  • K953385Lorenz 1.0MM, 1.5MM, 2.0MM SystemWalter Lorenz Surgical, Inc. · 19958cite it
  • K013954Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 20026cite it
  • K991029Rapidflap Cranial ClampWalter Lorenz Surgical, Inc. · 19996cite it
  • K033740Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 20035cite it

What has FDA decided for it lately?

  • 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
  • K042516OtomimixWalter Lorenz Surgical, Inc. · 2004
  • K030425Lorenz Resorbable Distraction System or ExpanderWalter Lorenz Surgical, Inc. · 2004
  • K040990Modification to Self-Drilling Radiographic MarkersWalter Lorenz Surgical, Inc. · 2004

All 56 as Walter Lorenz Surgical, Inc. →

What has been recalled?

22 recalls linked to its devices; the latest:

  • K031751RapidFire Clip, Item Number 95-0154 - Product Usage: Fixation of Craniofacial bone.Nov 25, 2020Class II
  • K972322Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - Product…Nov 25, 2020Class II
  • K031034Biomet Microfixation RapidFlap System 12mm SpinDown Clamp, sterile Ref Number: 75-1020…Aug 22, 2018Class II
  • K031034Biomet Microfixation RapidFlap System, 12MM RapidFlap SpinDown Clamp, 12 Pack Ref…Aug 22, 2018Class II
  • K031034Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp Ref Number: 75-1030…Aug 22, 2018Class II
  • K031034Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp, 12 Pack Ref Number…Aug 22, 2018Class II

Other applicant names beginning “Walter”

FDA records each applicant name separately; these may or may not be the same firm.

Walter Abendschein, M.D. 5Walter Ansted Co. 1