Surgical devices · 21 CFR 872 Subpart E
Intraosseous Fixation Screw
FDA device type “Screw, Fixation, Intraosseous”.
- Companies listing it
- 5846 makers
- Brands and models
- 1,206
- 510(k) clearances
- 819 in five years
- FDA name
- Screw, Fixation, Intraosseous
510(k) clearances per year, 1976–2026
Companies that list DZL
58 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Institut Straumann AG | Switzerland | Maker | MEMFIX · Neodent Graft Screw | 212 | 2026 |
| Dentis Co., Ltd. | South Korea | Maker | SAVE GBR | 37 | 2026 |
| Osstem Implant Co., Ltd. | South Korea | Maker | Bone Screw · Bone Tack · OssBuilder Healing Cap · OssBuilder Tenting Screw | 68 | 2026 |
| KLS Martin SE & Co. KG | Germany | Maker | — | 43 | 2026 |
| BioHorizons Implant Systems, Inc. | United States | Maker | ACE BONE SCREW TACKING KIT · The Autotac System · The Autotac System Titanium Tack | 41 | 2026 |
| Stryker | United States | Maker | add name · Delta DualStart · Delta Resorbable Fixation System · Delta System · +5 | 33 | 2024 |
| Young Innovations Inc | United States | Maker | Salvin Dental Fixation Screw · Salvin Dental Specialties Bone Tack System · Salvin Tenting Screws · Salvin Titanium Mesh | 23 | 2025 |
| X-NAV Technologies, LLC. | United States | Maker | EDX Bone Screw · EDX Tracker Arm · X-Guide Surgical Navigation System | 6 | 2026 |
| Neobiotech Co., Ltd. | South Korea | Maker | Neo GBR System | 17 | 2024 |
| Hager& Meisinger GmbH | Germany | Maker | Master Pin Control (Basic) · Master-Pin X · Meisinger Dental Bone Screw · Meisinger Tacs and Pins · +3 | 14 | 2025 |
| Osteomed, LLC | United States | Maker | — | 26 | 2022 |
| Beijing Naton Technology Group Co. Ltd. | China | Maker | Inion CPS 1.5/2/2.5 Bioabsorbable Fixation System · Inion CPS Baby 1.5 Bioabsorbable Fixation System | 10 | 2025 |
| Neoss AB | Sweden | Maker | — | 10 | 2022 |
| Jeil Medical Corporation | South Korea | Maker | Bone Fixation Screw Kit · GBR System · J Tac · J tack · +4 | 9 | 2026 |
| Microware Precision Co., Ltd. | Taiwan | Maker | Biomet Microfixation OmniMax MMF System · Tandry CMF Plate System | 2 | 2022 |
| DentalMaster (Xiamen) Medical Technology Co., Ltd. | China | Maker | Guided Bone Regeneration System | 1 | 2026 |
| Southern Medical (Pty) Ltd | South Africa | Maker | Southern Maxillofacial (MF) system | 1 | 2025 |
| Zimmer Inc | United States | Maker | Biomet Microfixation OmniMax MMF System · JUGGERKNOT MINI SOFT ANCHOR · LACTOSORB PUSH SCREW · LORENZ IMF SCREW · +2 | 14 | 2001 |
| Impladent , Ltd. | United States | Maker | TriStar Bone Graft Fixation System | 10 | 2014 |
| Medicon EG | Germany | Maker | — | 9 | 2005 |
| Biomet Microfixation | United States | Maker | IMF System · OmniMax · OmniMax MMF · OmniMax MMF System | 8 | 2021 |
| SYNTHES (USA) Products LLC | United States | Maker | DePuy Synthes Maxillofacial Portfolio - MR Conditional · RAPIDSORB PLUS SCREW SYSTEM · SMF STAINLESS STEEL BONE SCREWS · SMF TITANIUM (TI) ALLOY BONE SCREWS · +11 | 7 | 2020 |
| SYNTHES GMBH / Synthes Produktions GmbH | United States | Maker | SCREW, FIXATION, INTRAOSSEOUS · SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR · SYNTHES 1.5MM/2MM ORTHOGNATHIC MA · SYNTHES CARNIOFACIAL PLATE AND SCREW SYSTEM · +1 | 5 | 2013 |
| Osteogenics Biomedical, Inc. | United States | Maker | Pro-fix Bone Fixation Screws · Pro-fix Membrane Fixation Screws · Pro-fix Precision Fixation System · Pro-fix Tenting Screws | 5 | 2021 |
| OSTEONIC Co., Ltd. | South Korea | Maker | OPTIMUS CMF System | 3 | 2021 |
| Storz AM Mark GmbH | Germany | Maker | micro-screw · Titanium screw | 2 | 2008 |
| Surgident Co., Ltd. | South Korea | Maker | GBR System SD-Screw, Bone Tac · GBR System Titanium Mesh | 2 | 2019 |
| Mci Medical Concept Innovation, Inc. | United States | Maker | A011.1000 STRAIGHT MICRO PLATE 4H · A011.1002 STRAIGHT MICRO PLATE 6H · A011.1004 STRAIGHT MICRO PLATE 8H · A011.1006 STRAIGHT MICRO PLATE 10H · +1,061 | 1 | 2019 |
| NEOORTHO Produtos Ortopedicos S/A | Brazil | Maker | CranioMaxillofacial Fixation (CMF) System - CMF Visionare · Visionare | 1 | 2010 |
| Visionare LLC | United States | Maker | VISIONARE | 1 | 2018 |
| Vme Acquisition Corp. | United States | Maker | — | 1 | 1998 |
| Precision One Medical | United States | Maker | THE AUTOTAC SYSTEM TITANIUM TACK | — | — |
| MC Bio s.r.l. | Italy | Maker | MC Bio Supertack tack 3mm · MC Bio Supertack tack 4mm · MC Bio Supertack tack 5mm | — | — |
| Unique Instruments Inc. | United States | Maker | RAPIDSORB PLUS SCREW SYSTEM | — | — |
| LX Precision Shanghai Co. Ltd. | China | Maker | Biomet Microfixation OmniMax MMF System · 2 X 13MM IMF SCREW · 2X11MM T1 SD IMF SCREW · 2X15MM IMF SCREW · +2 | — | — |
| Jabil Inc. | United States | Maker | DePuy Synthes Maxillofacial Portfolio - MR Conditional · SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR · SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR | — | — |
| Tecomet | United States | Maker | Cranialplasty | — | — |
| Celestica de Monterrey S.A. de C.V. | Mexico | Maker | JGRKNT 1MM MINI STEP DRILL · 1mm JuggerKnot Mini 2-0 w/ Tapered Needles · 1mm JuggerKnot Mini 2-0 w/ Tapered Needles Multi Pack · 1mm JuggerKnot Mini 3-0 w/ Tapered Needles · +1 | — | — |
| Quality Aspirators | United States | Maker | Salvin Dental Fixation Screw | — | — |
| Eptam West LLC | United States | Maker | DZL - SCREW, FIXATION, INTRAOSSEOUS | — | — |
| Quintus, Inc. | United States | Maker | 4MM CARBON FIBER ROD | — | — |
| 3D Medical Manufacturing, inc. DBA Tecomet | United States | Maker | SYNTHES (USA) 1/1.22 MM CRANIOFACIAL SCREWS · SYNTHES 1MM TI. CORTEX SELF-DRILLING SCREWS (CARNIOFACIAL) | — | — |
| Eurofins inpac Medizintechnik GmbH | Germany | Maker | — | — | — |
| Helmut Zepf Medizintechnik GmbH | Germany | Maker | — | — | — |
| Part Precision Sweden AB | Sweden | Maker | — | — | — |
| Wesley Coe (Cambridge) Ltd. | United Kingdom | Maker | — | — | — |
| Nobel Biocare Services AG | Switzerland | Contract manufacturer | X-guide | 94 | 2026 |
| Suncoast Dental Corp. | United States | Repacker / relabeler | Tatum Surgical | 2 | 1981 |
| Sotera Health LLC | United States | Contract manufacturer | JUGGERKNOT 1MM MINI · JUGGERKNOT MINI SOFT ANCHOR · 311.5781S · 311.5791S | — | — |
| Swann Morton Limited | United Kingdom | Contract sterilizer | Membrane Screws and Membrane Tacks · SCREW, FIXATION, INTAOSSEOUS | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
| Exel Inc. dba DHL Supply Chain (USA) | United States | Repacker / relabeler | SMF STAINLESS STEEL BONE SCREWS · SMF TITANIUM (TI) ALLOY BONE SCREWS · SYNTHES (USA) 1/1.22 MM CRANIOFACIAL SCREWS · SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR · +6 | — | — |
| BBF Sterilisationsservice GmbH | Germany | Contract manufacturer | Screw, fixation, intraosseous | — | — |
| Curitiba Esterilizacao De Materiais Medicos LTDA | Brazil | Contract sterilizer | Neodent Graft Screw | — | — |
| HANSAMED LIMITED dba CITAGENIX | Canada | Foreign exporter | Citagenix | — | — |
| DePuy Synthes, Inc. | United States | Manufacturer | SYNTHES (USA) EXTERNAL MULTI VECTOR · SYNTHES 1.5MM/2MM ORTHOGNATHIC MA | — | — |
| Centerpiece Holdings LLC | United States | Contract sterilizer | BIOMET SPORTS MEDICINE | — | — |
| ZimmerBiomet Americas DFE | United States | Foreign exporter | JUGGERKNOT MINI SOFT ANCHOR | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 24 Aug 2026 | K254286 | Guided Bone Regeneration System | DentalMaster (Xiamen) Medical Technology Co., Ltd. |
| 29 Sep 2025 | K250123 | Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) | Hager& Meisinger GmbH |
| 13 Aug 2025 | K251569 | Bone Screw | Osstem Implant Co., Ltd. |
| 27 Jun 2025 | K243190 | USTOMED Bone Fixation/Bone Augmentation Systems - PIN | Ustomed Instrumente Ulrich Storz GmbH & Co. KG |
| 3 Jan 2025 | K233419 | GBR System | Proimtech Saglik Urunleri Anonim Sirketi |
| 17 Oct 2024 | K240321 | MP Pin flat without thread (36BMP000020/MP20) | Hager& Meisinger GmbH |
| 17 Sep 2024 | K233721 | KLS Martin Drill-Free MMF Screw | KLS Martin SE & Co. KG |
| 24 Aug 2023 | K231599 | Stryker MP, Mandible, HMMF and MMF AXS Screws | Stryker |
| 23 Mar 2023 | K222367 | SAVE GBR | Dentis Co., Ltd. |
| 8 Oct 2021 | K201210 | The Micro Screw System, Micro Screw System Basic | Hager& Meisinger GmbH |
| 5 Oct 2020 | K201561 | Membrane Screws and Membrane Tacks | Neoss AB |
| 9 Aug 2019 | K182881 | Bone Screw, Bone Tack | Osstem Implant Co., Ltd. |
| 7 May 2019 | K181854 | OssBuilder System | Osstem Implant Co., Ltd. |
| 26 Oct 2017 | K171831 | Intra-Lock Bone Fixation System | Intra-Lock International, Inc. |
| 28 Apr 2017 | K161857 | Salvin Tenting Screw System | Young Innovations Inc |
| 10 Jan 2017 | K160991 | Neo GBR System | Neobiotech Co., Ltd. |
| 26 May 2016 | K151540 | MC BIO Supertack Tack 3mm, 4mm and 5mm | Eli-Ka Technologies |
| 21 Sep 2015 | K151195 | OsteoMed IMF Screw | Osteomed, LLC |
| 2 Oct 2014 | K140908 | JUGGERKNOT MINI SOFT ANCHOR | Biomet Sports Medicine |
| 14 Feb 2014 | K132212 | DENTAL BONE SCREWS; DENTAL BONE SCREWS, CONTINUING; SCREW SYSTEM TX; SCREW SYSTEM TX PROFESSIONAL | Hager& Meisinger GmbH |
| 13 Aug 2013 | K130682 | MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT | Hager& Meisinger GmbH |
| 14 Feb 2011 | K103084 | NEODENT GRAFT SCREW | Jjgc Industria E Comercio DE Materiais Dentarios S |
| 8 Feb 2011 | K101902 | J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030 | Jeil Medical Corporation |
| 10 May 2010 | K100182 | SALVIN DENTAL SPECIALTIES FIXATION SCREW | Young Innovations Inc |
| 1 Mar 2010 | K093719 | PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT# | Osteogenics Biomedical, Inc. |
| 25 Jan 2010 | K093464 | RAPIDSORB PLUS SCREW SYSTEM | Synthes (Usa) |
| 29 Dec 2009 | K092855 | MILTEX MEMBRANE TACK KIT | Miltex, Inc. |
| 31 Mar 2009 | K083432 | DRILL FREE MMF SCREW | KLS Martin SE & Co. KG |
| 21 Nov 2008 | K080430 | STOMA BONE BLOCK SCREW | Storz AM Mark GmbH |
| 26 Mar 2008 | K073342 | SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW | Young Innovations Inc |
| 30 Mar 2007 | K063769 | ALPHA BIO BONE FIXATION SCREW SYSTEM | Alpha-Bio Tec |
| 27 Oct 2005 | K051871 | STOMA BONE SCREW | Storz AM Mark GmbH |
| 6 Apr 2005 | K050606 | SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL) | Synthes (Usa) |
| 5 Apr 2005 | K050515 | BONE BLOCK FIXATION SET | Institut Straumann AG |
| 17 Mar 2005 | K050535 | STRYKER MMF SCREW | Stryker |
| 18 Oct 2004 | K042573 | KLS MARTIN DRILL-FREE MMF SCREW | KLS Martin SE & Co. KG |
| 19 Aug 2004 | K041887 | SYNTHES (USA) 1.0/1.22 MM CRANIOFACIAL SCREWS | Synthes (Usa) |
| 2 Jul 2003 | K031807 | SYNTHES LOW PROFILE NEURO SYSTEM - 3 MM SCREWS | Synthes (Usa) |
| 28 Aug 2002 | K022790 | THE AUTOTAC SYSTEM TITANIUM TACK | BioHorizons Implant Systems, Inc. |
| 10 Jun 2002 | K021850 | SYNTHES (USA) 1.3 MM CRANIOFACIAL SCREWS | Synthes (Usa) |
| 21 May 2002 | K021522 | LORENZ 1.5 X 4 MM LACTOSORB TAP FREE SCREW | Walter Lorenz Surgical, Inc. |
| 16 Jan 2002 | K012486 | OSTEOMED BIORESORBABLE FIXATION SYSTEM | Osteomed, LLC |
| 28 Nov 2001 | K012908 | BIOPLATE RESORBABLE BONE SCREW | Bioplate, Inc. |
| 22 Jun 2001 | K011675 | THE AUTOTAC SYSTEM | BioHorizons Implant Systems, Inc. |
| 18 May 2001 | K010690 | SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR | Synthes (Usa) |
| 25 Apr 2001 | K010527 | SYNTHES (USA) IMF SCREWS | Synthes (Usa) |
| 16 Nov 2000 | K002935 | SYNTHES 1.5MM TI BROW LIFT SCREW | Synthes (Usa) |
| 20 Oct 2000 | K002423 | LACTOSORB PUSH SCREW | Zimmer Inc |
| 7 Jan 2000 | K993493 | THE AUTOTAC SYSTEM | BioHorizons Implant Systems, Inc. |
| 29 Dec 1999 | K993575 | RESOLVE QUICKANCHOR | Mitek Products |
| 21 Dec 1999 | K980760 | KLS-MARTIN MMF SCREW | KLS Martin SE & Co. KG |
| 16 Dec 1999 | K993327 | TALON ANCHOR SNAP-PAK | Mitek Products |
| 2 Nov 1999 | K992623 | MITEK MINI ANCHOR | Mitek Products |
| 21 Jun 1999 | K982951 | IMTEC BIOPIN | Imtec Corp. |
| 13 May 1999 | K983728 | LORENZ IMF SCREW | Walter Lorenz Surgical, Inc. |
| 21 Dec 1998 | K983485 | SYNTHES 1.3 MM SELF-DRILLING SCREW | Synthes (Usa) |
| 2 Dec 1998 | K981881 | DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRILLING, COCRMO SELF-TAPPING/ SELF DRILLING | Doctor'S Research Group, Inc. |
| 3 Nov 1998 | K981666 | 2.5 MM LACTOSORB SCREWS | Zimmer Inc |
| 8 Sep 1998 | K982927 | QUICK TAP SELF DRILLING SCREW | Vme Acquisition Corp. |
| 14 Jul 1998 | K981459 | MEMBRANE TACK | Zimmer Inc |
| 29 Jun 1998 | K981362 | SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR | Synthes (Usa) |
| 17 Apr 1998 | K980199 | SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWS | Synthes (Usa) |
| 13 Mar 1998 | K974817 | DRG MF TITANIUN ALLOY BONE SCREW 1.0MM, 1.2MM, 1.3MM, 1.5MM, 1.7MM, 2.0MM, 2.4MM | Doctor'S Research Group, Inc. |
| 30 Jan 1998 | K974392 | LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM | Biovision GmbH |
| 23 Dec 1997 | K972480 | 3I BIORESORBABLE FIXATION TACK | Implant Innovations, Inc. |
| 18 Nov 1997 | K973180 | IMTEC BONE TAC | Imtec Corp. |
| 12 Nov 1997 | K973056 | BONE GRAFT SCREW SYSTEM | Bicon, LLC |
| 10 Oct 1997 | K962774 | OSTEOMED QUICKFIX | Osteomed, LLC |
| 24 Jun 1997 | K963546 | SMF TITANIUM (TI) ALLOY BONE SCREWS | Synthes (Usa) |
| 11 Apr 1997 | K964261 | SMF STAINLESS STEEL BONE SCREWS | Synthes (Usa) |
| 25 Oct 1996 | K961418 | OSTEOMED MSS | Osteomed, LLC |
| 24 May 1996 | K960945 | IMZ MEMBRANE TACK SYSTEM | Interpore Intl. |
| 23 Jan 1996 | K955369 | MEMFIX | The Straumann Co. |
| 5 Jan 1996 | K955140 | 2.0 X 6MM SCREW | Brasseler USA I, L.P. |
| 21 Nov 1995 | K952167 | IMZ BONE TACK SYSTEM | Interpore Intl. |
| 25 Aug 1995 | K951510 | ACE BONE SCREW TACKING KIT | Ace Surgical Supply Company, Inc. |
| 30 Sep 1991 | K910427 | MEMFIX SCREWS | W. L. Gore & Associates, Inc. |
| 21 Aug 1991 | K911936 | OSTEOMED SBF SYSTEM (SBF) | Osteomed, LLC |
| 20 Aug 1991 | K911165 | SCREW, BONE, MAXILLOFACIAL | Tekno-Medical |
| 28 Jan 1977 | K770131 | LEW PROSTHETIC LOCKING DEVICE | Howmedica Corp. |
| 15 Dec 1976 | K761228 | LUHR MANDIBULAR COMPRESSION-SCREW SYSTEM | Howmedica Corp. |
Official records: FDA product classification for DZL · 21 CFR 872.4880.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026