Surgical devices · 21 CFR 872 Subpart E
External Mandibular Fixator and/or Distractor
FDA device type “External Mandibular Fixator And/Or Distractor”.
- Companies listing it
- 1915 makers
- Brands and models
- 57
- 510(k) clearances
- 601 in five years
- FDA name
- External Mandibular Fixator And/Or Distractor
510(k) clearances per year, 1976–2026
Companies that list MQN
19 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| KLS Martin SE & Co. KG | Germany | Maker | — | 43 | 2026 |
| Stryker | United States | Maker | MANDIBULAR BONE DISTRACTOR II · PMD · PMD 2 · Stryker Pediatric Mandibular Distractor · +1 | 33 | 2024 |
| Osteomed, LLC | United States | Maker | — | 26 | 2022 |
| Zimmer Inc | United States | Maker | LORENZ BLUE DEVICE · LORENZ DISTRACTION · SYSTEM | 14 | 2001 |
| Biomet Microfixation | United States | Maker | Lorenz Blue Device · Lorenz Distraction System | 8 | 2021 |
| SYNTHES (USA) Products LLC | United States | Maker | CMFD Mandible · DePuy Synthes Maxillofacial Portfolio - MR Conditional · Mandible External Fixator - MR Conditional · mandibular fiaxtion · +11 | 7 | 2020 |
| Medartis AG | Switzerland | Maker | MODUS Modular Distraction Osteogenesis System | 6 | 2007 |
| SYNTHES GMBH / Synthes Produktions GmbH | United States | Maker | EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR · MANDIBLE EXTERNAL FIXATOR · MINI LENGTHENING APPARATUS · SYNTHES (USA) ALVEOLAR RIDGE DISTRA · +2 | 5 | 2013 |
| Unique Instruments Inc. | United States | Maker | Synthes External Midface Distractor | — | — |
| Jabil Inc. | United States | Maker | CMFD Mandible · DePuy Synthes Maxillofacial Portfolio - MR Conditional · MANDIBLE EXTERNAL FIXATOR · MINI LENGTHENING APPARATUS · +2 | — | — |
| Complexus Medical | United States | Maker | Set Screw Dog Point M4x5, Blue Device · 180mm Carbon Rod, Blue Device · 25mm Qc Dual Rail Distractor | — | — |
| Quintus, Inc. | United States | Maker | CARBON FIBER ROD | — | — |
| Autocam Medical | United States | Maker | — | — | — |
| Avalign Instruments & Implants | United States | Maker | — | — | — |
| KLS Martin Manufacturing, LLC | United States | Maker | — | — | — |
| Sotera Health LLC | United States | Contract manufacturer | Macropore DX Distractor System · 03.305.500S | — | — |
| Exel Inc. dba DHL Supply Chain (USA) | United States | Repacker / relabeler | Craniomaxillofacial Distraction System (CMFD) · SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM · SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM · SYNTHES (USA) RATCHETING DISTRACTOR · +6 | — | — |
| BBF Sterilisationsservice GmbH | Germany | Contract manufacturer | External mandibular fixator and/or distractor | — | — |
| DePuy Synthes, Inc. | United States | Manufacturer | SYNTHES MANDIBLE EXTERNAL FIXATOR | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 11 Aug 2022 | K220050 | KLS Martin IPS Distraction | KLS Martin SE & Co. KG |
| 13 Mar 2019 | K183113 | DePuy Synthes Maxillofacial Portfolio - MR Conditional | SYNTHES (USA) Products LLC |
| 11 Sep 2018 | K181504 | Stryker Pediatric Mandibular Distractor 2 | Stryker |
| 8 May 2017 | K162594 | Craniomaxillofacial Distraction System (CMFD) | SYNTHES (USA) Products LLC |
| 1 Dec 2016 | K161470 | Internal Distraction - Sterile | KLS Martin SE & Co. KG |
| 28 May 2015 | K143285 | Mandible External Fixator - MR Conditional | SYNTHES (USA) Products LLC |
| 20 Mar 2014 | K133398 | STRYKER PEDIATRIC MANDIBLE DISTRACTOR | Stryker |
| 23 Aug 2012 | K121502 | SYNTHES CURVILINEAR DISTRACTION SYSTEM | SYNTHES GMBH / Synthes Produktions GmbH |
| 17 Dec 2008 | K080458 | MIS CREST WIDENER | Mis - Implant Technologies , Ltd. |
| 15 Dec 2008 | K080542 | DISTRAX | John W. King |
| 14 May 2008 | K080153 | SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM | Synthes (Usa) |
| 20 Dec 2007 | K072764 | KLS MARTIN XTERNAL FIXATOR | KLS Martin SE & Co. KG |
| 10 Aug 2007 | K071628 | STRYKER EXTERNAL FIXATION SYSTEM | Stryker Cmf |
| 11 May 2007 | K062572 | CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATE | Custom Scientific |
| 2 Mar 2007 | K063792 | OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM | Osteomed, LLC |
| 17 Nov 2006 | K062851 | OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDED | Osteomed, LLC |
| 31 Aug 2006 | K062299 | SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT | Synthes (Usa) |
| 2 Jun 2006 | K060138 | SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM | Synthes (Usa) |
| 22 Aug 2005 | K051946 | MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM | Medartis AG |
| 12 Apr 2005 | K043555 | SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR | Synthes (Usa) |
| 15 Mar 2005 | K050378 | SYNTHES MANDIBLE EXTERNAL FIXATOR | Synthes (Usa) |
| 10 Feb 2005 | K043434 | OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM | Osteomed, LLC |
| 28 Jan 2005 | K042278 | ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5) | Oral Osteodistraction, L.P. |
| 14 Apr 2004 | K040169 | SYNTHES MANDIBLE EXTERNAL FIXATOR | Synthes (Usa) |
| 31 Mar 2004 | K040083 | SYNTHES EXTERNAL MIDFACE DISTRACTOR | Synthes (Usa) |
| 23 Mar 2004 | K034045 | ORAL OSTEODISTRACTION DISTRACTION ROD APPLIANCES, ROD 4 | Oral Osteodistraction, L.P. |
| 27 Feb 2004 | K034027 | KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM | KLS Martin SE & Co. KG |
| 3 Dec 2003 | K030485 | NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR | Newmedical Technology, Inc. |
| 3 Nov 2003 | K031708 | OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEM | Osteomed, LLC |
| 29 Oct 2003 | K033065 | SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES | Synthes (Usa) |
| 29 Oct 2003 | K032442 | KLS-MARTIN MANDIBULAR/RECONSTRUCTION SYSTEM II | KLS Martin SE & Co. KG |
| 10 Sep 2003 | K030790 | OSTEOMED ALVEOLAR DISTRACTION SYSTEM | Osteomed, LLC |
| 17 Jun 2003 | K031696 | LORENZE EXTERNAL MANDIBULAR DISTRACTOR | Walter Lorenz Surgical, Inc. |
| 4 Feb 2003 | K014001 | DISTRACTION OSTEOGENESIS ROD APPLIANCES, MODELS 1, 2, AND 3 | Oral Osteodistraction, L.P. |
| 14 Aug 2002 | K013618 | INTRAORAL MANDIBULAR DISTRACTION SYSTEM | Osteomed, LLC |
| 22 Feb 2002 | K020407 | LORENZ BLUE DEVICE | Walter Lorenz Surgical, Inc. |
| 29 Jun 2001 | K010139 | ZURICH DISTRACTION SYSTEM | KLS Martin SE & Co. KG |
| 10 Oct 2000 | K002152 | TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION | KLS Martin SE & Co. KG |
| 24 Jul 2000 | K000580 | ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15 | KLS Martin SE & Co. KG |
| 26 Jun 2000 | K000992 | MACROPOREDX DISTRACTOR SYSTEM | Macropore Biosurgery, Inc. |
| 19 Jan 2000 | K993869 | INTER-OS BONE GENERATOR | Inter-Os Technologies, LLC |
| 19 Nov 1999 | K992952 | LORENZ DISTRACTION SYSTEM | Walter Lorenz Surgical, Inc. |
| 17 Sep 1999 | K992873 | LORENZ EXTERNAL MANDIBULAR DISTRACTOR | Walter Lorenz Surgical, Inc. |
| 18 Aug 1999 | K991875 | K-L-W INTRAORAL DISTRACTOR | KLS Martin SE & Co. KG |
| 16 Jun 1999 | K990944 | OSTEOMED INTRAORAL DISTRACTION SYSTEM | Osteomed, LLC |
| 10 Feb 1999 | K984117 | INNOVA TELESCOPIC DISTRACTOR | Innova Corp. |
| 26 Jan 1999 | K983809 | KLS MARTIN INTRAORAL ZURICH RAMUS DISTRACTOR | KLS Martin SE & Co. KG |
| 30 Nov 1998 | K983515 | KLS INTRAORAL VERTICAL DISTRACTOR | KLS Martin SE & Co. KG |
| 12 Nov 1998 | K982906 | LORENZ INTRAORAL LINEAR MANDIBULAR DISTRACTION SYSTEM | Walter Lorenz Surgical, Inc. |
| 23 Oct 1998 | K982604 | LORENZ MAXILLA (LE FORT) DISTRACTION SYSTEM | Walter Lorenz Surgical, Inc. |
| 25 Jun 1998 | K981275 | SYNTHES (USA) RATCHETING DISTRACTOR | Synthes (Usa) |
| 22 Jun 1998 | K981075 | SYNTHES (USA) (SYNTHES) SINGLE VECTOR DISTRACTOR WITH DETACHABLE FEET | Synthes (Usa) |
| 20 Nov 1997 | K973275 | KLS-MARTIN INTRAORAL DISTRACTOR | KLS Martin SE & Co. KG |
| 10 Nov 1997 | K973018 | SYNTHES MINI LENGTHENING APPARATUS | Synthes (Usa) |
| 24 Jun 1997 | K972047 | KLS-MARTIN RIGID EXTERNAL DISTRACTION DEVICE | KLS Martin SE & Co. KG |
| 30 Aug 1996 | K962272 | SYNTHES MANDIBLE DISTRACTOR | Synthes (Usa) |
| 6 Aug 1996 | K960297 | MANDIBULAR BONE DISTRACTOR II | Howmedica Corp. |
| 14 Feb 1996 | K955640 | LORENZ MANDIBULAR DISTRACTOR | Zimmer Inc |
| 6 Feb 1996 | K952847 | NORMED BIDIRECTRIONAL/MULTIDIRECTIONAL JAW DISTRACTOR | Ace Surgical Supply Company, Inc. |
| 2 Jun 1995 | K945674 | MANDIBULAR BONE DISTRACTOR | Howmedica Corp. |
Official records: FDA product classification for MQN · 21 CFR 872.4760.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026