Manufacturer registered with FDA
Biomet Microfixation
Jacksonville, FL, United States. Lists 34 dental device types with FDA across 1 registered establishment, and holds 8 510(k) clearances as applicant.
- Device types listed
- 34
- Brands and models
- 80
- 510(k) clearances
- 82008–2021
- Markets registered in
- 133,126 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2000–2026
Registered in 13 markets
Where regulators' registries name Biomet Microfixation as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Biomet Microfixation | 8 clearances | 2008–2021 | Below |
| Thailand | Thai FDA | Manufacturer | BIOMET MICROFIXATION | 2,609 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Biomet Microfixation | 152 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Biomet Microfixation | 145 | 1999–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Biomet MicrofixationBIOMET MICROFIXATION | 69 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | BIOMET MICROFIXATION | 68 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | BIOMET MICROFIXATIONBIOMET MICROFIXATION, INC | 24 | 2003–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | BIOMET MICROFIXATIONBIOMET Microfixation · BIOMET MICROFIXATION,INC. | 24 | 2004–2025 | Pure Global AI |
| China | NMPA | Registration holder | 邦美微固定公司Biomet Microfixation | 12 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Biomet Microfixation | 11 | 2023–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | BIOMET MICROFIXATION | 6 | 2013–2020 | Pure Global AI |
| Israel | AMAR | Manufacturer | Biomet Microfixation | 5 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | BIOMET MICROFIXATION, INC. | 1 | 2014–2014 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Biomet Microfixation currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Maker | Bi PhaseCMF SystemFracture/Reconstruction PlatingMandibular Fracture/Reconstruction DevicesNeuro SystemOmniMaxOmniMax MMFOmniMax MMF SystemPre-Bent PlatePre-bent Plates with Virtual Surgical Planning 12 morePreBent PlatesReconstruction System with Modular ScrewSterile Bone Plates and ScrewsSterileTracTMS SystemTraumaOne SystemVirtual Surgical PlanningVSP1.5mm System1mm System2.3mm System2mm System | 1992 |
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Maker | IMF SystemOmniMaxOmniMax MMFOmniMax MMF System | 2003 |
| Manual Wire Driver and Bone DrillDZJ · Class 2 | Surgical drills & motors | Maker | Pre-bent Plates with Virtual Surgical PlanningVirtual Surgical PlanningVSP | 2015 |
| External Mandibular Fixator and/or DistractorMQN · Class 2 | Maxillofacial plates & screws | Maker | Lorenz Blue DeviceLorenz Distraction System | 2012 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Lister | Arch BarPrestretched WireWire | 2003 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Self Drilling IMF Screw | 2012 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Lister | Seldin Root Pick | 2012 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Lister | Dental Mirror | 2003 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Lister | CHIP BLOWERSYRINGE | 2014 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Lister | Orthodontic BandRubber Band | 2010 |
| Orthodontic Ligature Tucking InstrumentECP · Class 1 | Dental hand instruments | Lister | Gauze DirectorLigature Tucker | 2003 |
| Orthodontic Band SetterECR · Class 1 | Dental hand instruments | Lister | Band Pusher | 2021 |
| Orthodontic Band PusherECS · Class 1 | Dental hand instruments | Lister | Pusher | 2003 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Lister | Dressing ForcepsTowel Forceps | 2003 |
| Dental Surgical Tissue ScissorsEGN · Class 1 | Dental hand instruments | Lister | Palate ScissorsScissors | 2003 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Lister | Aquafix SyringeAspirating SyringeSyringe | 2003 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | Mouth PropQC Removal ToolRetractor | 2003 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Cheek RetractorCondyle RetractorRetractorTMJ Retractor | 2003 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Lister | Dental Gauge | 2003 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Lister | Periodontal Probe | 2012 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | Handle | 2003 |
| ArticulatorsEJP · Class 1 | Articulators & facebows | Lister | Articulator | 1992 |
| Operative ExplorerEKB · Class 1 | Dental hand instruments | Lister | Explorer | 2003 |
| Operative Amalgam CarrierEKI · Class 1 | Dental hand instruments | Lister | Carrier | 2003 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Lister | Extracting Forceps | 2003 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Lister | Bone Cutting ForcepsRongeur | 2003 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Lister | Bone File | 2003 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Lister | Dental ElevatorElevatorPeriosteal Elevator | 2003 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Lister | ChiselOsteotome | 2003 |
| Surgical Osteotome ChiselEMM · Class 1 | Dental hand instruments | Lister | ChiselOsteotome | 2003 |
| Implant Temporomandibular JointLZD · Class 3 | — | Maker | TMJ | 2007 |
| Nose and Throat Ear CementNEA · Class 2 | — | Maker | OTOMIMIX | 2004 |
| Temporary Mandibular Condyle ProsthesisNEI · Class 2 | — | Maker | Add on Condyle | 2009 |
| Orthodontic Endosseous ImplantOAT · Class 2 | — | Maker | ORTHODONTIC ANCHORAGE SYSTEM | 2007 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Biomet Microfixation as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 5 Aug 2021 | K202969 | Biomet Microfixation OmniMax MMF System | JEY Bone Plate |
| 10 Dec 2015 | K152326 | Biomet Microfixation OmniMax MMF System | JEY Bone Plate |
| 1 Apr 2015 | K143336 | Biomet Microfixation OmniMax MMF System | JEY Bone Plate |
| 2 Oct 2013 | K132600 | FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING | JEY Bone Plate |
| 8 Aug 2013 | K131674 | PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING | JEY Bone Plate |
| 21 Sep 2012 | K121589 | BIOMET MICROFIXATION FACIAL PLATING SYSTEM | JEY Bone Plate |
| 29 Jun 2012 | K113512 | BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT PLATES SYSTEM | JEY Bone Plate |
| 9 May 2008 | K081067 | FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE) | JEY Bone Plate |
Also lists devices cleared under other names
Biomet Microfixation lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Walter Lorenz Surgical, Inc. (15).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 9 Feb 2007 | K063386 | LORENZ ORTHODONTIC ANCHORAGE SYSTEM | Walter Lorenz Surgical, Inc. | OAT Orthodontic Endosseous Implant |
| 12 Jan 2007 | K063052 | LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES | Walter Lorenz Surgical, Inc. | JEY Bone Plate |
| 8 Nov 2004 | K042516 | OTOMIMIX | Walter Lorenz Surgical, Inc. | NEA Nose and Throat Ear Cement |
| 5 May 2004 | K040983 | LORENZ SELF-DRILLING IMF SCREW | Walter Lorenz Surgical, Inc. | DZE Root-Form Endosseous Implant |
| 22 Feb 2002 | K020407 | LORENZ BLUE DEVICE | Walter Lorenz Surgical, Inc. | MQN External Mandibular Fixator and/or Distractor |
| 6 Aug 2001 | K002790 | ADD-ON CONDYLE | Walter Lorenz Surgical, Inc. | NEI Temporary Mandibular Condyle Prosthesis |
| 3 May 2000 | K001238 | LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM | Walter Lorenz Surgical, Inc. | JEY Bone Plate |
| 19 Nov 1999 | K992952 | LORENZ DISTRACTION SYSTEM | Walter Lorenz Surgical, Inc. | MQN External Mandibular Fixator and/or Distractor |
| 13 May 1999 | K983728 | LORENZ IMF SCREW | Walter Lorenz Surgical, Inc. | DZL Intraosseous Fixation Screw |
| 11 May 1998 | K980512 | LORENZ RECONSTRUCTION SYSTEM WITH MODULAR SCREW | Walter Lorenz Surgical, Inc. | JEY Bone Plate |
| 18 Aug 1997 | K972322 | LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATES | Walter Lorenz Surgical, Inc. | JEY Bone Plate |
| 28 Sep 1995 | K953385 | LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEM | Walter Lorenz Surgical, Inc. | JEY Bone Plate |
| 23 Dec 1992 | K922741 | LORENZ 1.0 MM SYSTEM | Walter Lorenz Surgical, Inc. | JEY Bone Plate |
| 20 Feb 1991 | K910038 | LORENZ ULTRA-MICRO TITANIUM OSTEOSYNTHESIS SYSTEM | Walter Lorenz Surgical, Inc. | JEY Bone Plate |
| 21 Jan 1986 | K854886 | WUERZBURG TITANIUM MINI BONE PLATES & BONE SCREWS | Walter Lorenz Surgical, Inc. | JEY Bone Plate |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BIOMET MICROFIXATIONFDA reg. 1032347 | Jacksonville, FL, United States | Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1032347). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.