External Mandibular Fixator And/Or Distractor
FDA product code MQN · Class II (moderate risk) · 21 CFR 872.4760 · Dental
60510(k) clearances
0PMA approvals
9recalls
Implantimplanted device
Manufacturers
- KLS-Martin L.P. 13
- Synthes (Usa) 12
- Osteomed LP 7
- Walter Lorenz Surgical, Inc. 6
- Oral Osteodistraction, L.P. 3
- Synthes (USA) Products LLC 3
- Howmedica Corp. 2
- Stryker Corporation 2
- Innova Corp. 1
- Biomet, Inc. 1
- Inter-Os Technologies, LLC 1
- Macropore Biosurgery, Inc. 1
- Newmedical Technology, Inc. 1
- Medartis AG 1
- Custom Scientific 1
- Stryker Cmf 1
- John W. King 1
- Mis - Implant Technologies , Ltd. 1
- Synthes, Inc. 1
- Ace Surgical Supply Co., Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220050 | KLS Martin IPS DistractionMQN · Traditional | KLS Martin L.P. | 08/11/2022SE |
| K183113 | DePuy Synthes Maxillofacial Portfolio - MR ConditionalMQN · Traditional | Synthes (USA) Products, LLC | 03/13/2019SE |
| K181504 | Stryker Pediatric Mandibular Distractor 2MQN · Traditional | Stryker | 09/11/2018SE |
| K162594 | Craniomaxillofacial Distraction System (CMFD)MQN · Traditional | Synthes USA Products, LLC | 05/08/2017SE |
| K161470 | Internal Distraction - SterileMQN · Traditional | KLS Martin L.P. | 12/01/2016SE |
| K143285 | Mandible External Fixator - MR ConditionalMQN · Traditional | Synthes USA Products, LLC | 05/28/2015SE |
| K133398 | Stryker Pediatric Mandible DistractorMQN · Traditional | Stryker | 03/20/2014SE |
| K121502 | Synthes Curvilinear Distraction SystemMQN · Traditional | Synthes, Inc. | 08/23/2012SE |
| K080458 | Mis Crest WidenerMQN · Traditional | Mis - Implant Technologies , Ltd. | 12/17/2008SE |
| K080542 | DistraxMQN · Traditional | John W. King | 12/15/2008SE |
| K080153 | Synthes (USA) Curvilinear Distraction SystemMQN · Traditional | Synthes (Usa) | 05/14/2008SE |
| K072764 | KLS Martin Xternal FixatorMQN · Traditional | KLS Martin L.P. | 12/20/2007SE |
| K071628 | Stryker External Fixation SystemMQN · Traditional | Stryker Cmf | 08/10/2007SE |
| K062572 | Craniotech Bone Transport Reconstruction PlateMQN · Traditional | Custom Scientific | 05/11/2007SE |
| K063792 | Osteomed External Mandibular Distraction SystemMQN · Traditional | Osteomed LP | 03/02/2007SE |
| K062851 | Osteomed Pediatric Intraoral Mandibular Distraction System, ExtendedMQN · Traditional | Osteomed LP | 11/17/2006SE |
| K062299 | Synthes Sterile Mandible External Fixation KitMQN · Special | Synthes (Usa) | 08/31/2006SE |
| K060138 | Synthes (USA) Craniomaxillofacial Distraction SystemMQN · Traditional | Synthes (Usa) | 06/02/2006SE |
| K051946 | Modus Modular Distraction Osteogenesis SystemMQN · Traditional | Medartis, Inc. | 08/22/2005SE |
| K043555 | Synthes 9USA) Alveolar Ridge DistractorMQN · Traditional | Synthes (Usa) | 04/12/2005SE |
| K050378 | Synthes Mandible External FixatorMQN · Traditional | Synthes (Usa) | 03/15/2005SE |
| K043434 | Osteomed Pediatric Intraoral Mandibular Distraction SystemMQN · Traditional | Osteomed LP | 02/10/2005SE |
| K042278 | Oral Osteodistraction Rod Appliance (Rod 5)MQN · Traditional | Oral Osteodistraction, L.P. | 01/28/2005SE |
| K040169 | Synthes Mandible External FixatorMQN · Traditional | Synthes (Usa) | 04/14/2004SE |
| K040083 | Synthes External Midface DistractorMQN · Traditional | Synthes (Usa) | 03/31/2004SE |
| K034045 | Oral Osteodistraction Distraction Rod Appliances, Rod 4MQN · Traditional | Oral Osteodistraction, L.P. | 03/23/2004SE |
| K034027 | KLS Martin 3DX External Distraction SystemMQN · Traditional | KLS-Martin L.P. | 02/27/2004SE |
| K030485 | Newmedical Micro Bone Distractor/FixatorMQN · Traditional | Newmedical Technology, Inc. | 12/03/2003SE |
| K031708 | Osteomed Maxillary/Lefort III Distraction SystemMQN · Traditional | Osteomed LP | 11/03/2003SE |
| K033065 | Synthes 2.0 MM Craniofacial Locking PlatesMQN · Traditional | Synthes (Usa) | 10/29/2003SE |
| K032442 | Kls-Martin Mandibular/Reconstruction System IIMQN · Traditional | KLS-Martin L.P. | 10/29/2003SE |
| K030790 | Osteomed Alveolar Distraction SystemMQN · Traditional | Osteomed LP | 09/10/2003SE |
| K031696 | Lorenze External Mandibular DistractorMQN · Special | Walter Lorenz Surgical, Inc. | 06/17/2003SE |
| K014001 | Distraction Osteogenesis Rod Appliances, Models 1, 2, and 3MQN · Traditional | Oral Osteodistraction, L.P. | 02/04/2003SE |
| K013618 | Intraoral Mandibular Distraction SystemMQN · Traditional | Osteomed Corp. | 08/14/2002SE |
| K020407 | Lorenz Blue DeviceMQN · Special | Walter Lorenz Surgical, Inc. | 02/22/2002SE |
| K010139 | Zurich Distraction SystemMQN · Traditional | KLS-Martin L.P. | 06/29/2001SE |
| K002152 | Track 1.0 & 1.5 MM Systems-Tissue Regeneration by Alveolar Callus DistractionMQN · Traditional | KLS-Martin L.P. | 10/10/2000SE |
| K000580 | Zurich Pediatric Maxillary Distractor, Models 51-550-15 and 51-551-15MQN · Traditional | KLS-Martin L.P. | 07/24/2000SE |
| K000992 | Macroporedx Distractor SystemMQN · Traditional | Macropore Biosurgery, Inc. | 06/26/2000SE |
| K993869 | Inter-Os Bone GeneratorMQN · Traditional | Inter-Os Technologies, LLC | 01/19/2000SE |
| K992952 | Lorenz Distraction SystemMQN · Traditional | Walter Lorenz Surgical, Inc. | 11/19/1999SE |
| K992873 | Lorenz External Mandibular DistractorMQN · Special | Walter Lorenz Surgical, Inc. | 09/17/1999SE |
| K991875 | K-L-W Intraoral DistractorMQN · Traditional | KLS-Martin L.P. | 08/18/1999SE |
| K990944 | Osteomed Intraoral Distraction SystemMQN · Traditional | Osteomed Corp. | 06/16/1999SE |
| K984117 | Innova Telescopic DistractorMQN · Traditional | Innova Corp. | 02/10/1999SE |
| K983809 | KLS Martin Intraoral Zurich Ramus DistractorMQN · Traditional | KLS-Martin L.P. | 01/26/1999SE |
| K983515 | KLS Intraoral Vertical DistractorMQN · Traditional | KLS-Martin L.P. | 11/30/1998SE |
| K982906 | Lorenz Intraoral Linear Mandibular Distraction SystemMQN · Traditional | Walter Lorenz Surgical, Inc. | 11/12/1998SE |
| K982604 | Lorenz Maxilla (Le Fort) Distraction SystemMQN · Traditional | Walter Lorenz Surgical, Inc. | 10/23/1998SE |
| K981275 | Synthes (USA) Ratcheting DistractorMQN · Traditional | Synthes (Usa) | 06/25/1998SE |
| K981075 | Synthes (USA) (Synthes) Single Vector Distractor with Detachable FeetMQN · Traditional | Synthes (Usa) | 06/22/1998SE |
| K973275 | Kls-Martin Intraoral DistractorMQN · Traditional | KLS-Martin L.P. | 11/20/1997SE |
| K973018 | Synthes Mini Lengthening ApparatusMQN · Traditional | Synthes (Usa) | 11/10/1997SE |
| K972047 | Kls-Martin Rigid External Distraction DeviceMQN · Traditional | KLS-Martin L.P. | 06/24/1997SE |
| K962272 | Synthes Mandible DistractorMQN · Traditional | Synthes (Usa) | 08/30/1996SE |
| K960297 | Mandibular Bone Distractor IIMQN · Traditional | Howmedica Corp. | 08/06/1996SE |
| K955640 | Lorenz Mandibular DistractorMQN · Traditional | Biomet, Inc. | 02/14/1996SE |
| K952847 | Normed Bidirectrional/Multidirectional Jaw DistractorMQN · Traditional | Ace Surgical Supply Co., Inc. | 02/06/1996SE |
| K945674 | Mandibular Bone DistractorMQN · Traditional | Howmedica Corp. | 06/02/1995SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2586-2016 Class II | TI Single Vector Distractor Proximal Foot/Left; Catalog ID 487.975 The Titanium Single…DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single… | Synthes (USA) Products LLC | 05/23/2016Terminated |
| Z-2585-2016 Class II | TI Single Vector Distractor Proximal Foot/Right; Catalog ID 487.974 The Titanium Single…DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single… | Synthes (USA) Products LLC | 05/23/2016Terminated |
| Z-2584-2016 Class II | TI Single Vector Distractor Body with Left Foot/30mm; Catalog ID 487.965 The Titanium…DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single… | Synthes (USA) Products LLC | 05/23/2016Terminated |
| Z-2583-2016 Class II | TI Single Vector Distractor Body with Right Foot/30mm; Catalog ID 487.964 The Titanium…DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single… | Synthes (USA) Products LLC | 05/23/2016Terminated |
| Z-2582-2016 Class II | TI Single Vector Distractor Body with Left Foot/20mm; Catalog ID 487.963 The Titanium…DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single… | Synthes (USA) Products LLC | 05/23/2016Terminated |
| Z-2581-2016 Class II | TI Single Vector Distractor Body with Right Foot/20mm; Catalog ID 487.962 The Titanium…DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single… | Synthes (USA) Products LLC | 05/23/2016Terminated |
| Z-1009-2015 Class II | The Synthes Mandible External Fixator; all lots of part nos.: 04.305.003 04.305.004…Under new testing protocols for MR Environment safety and compatibility, metal devices are no longer… | Synthes, Inc. | 10/17/2014Terminated |
| Z-2148-2014 Class I | DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC…DePuy Synthes is initiating a recall of certain lots of the Craniomaxillofacial Distraction System (AB… | Synthes, Inc. | 04/16/2014Terminated |
| Z-1726-2013 Class II | Synthes CMF Distraction System The product is intended for use as a bone stabilizer and…The firm initiated a voluntary recall of the BC Distractor Body which is part of the Craniomaxillofacial… | Synthes USA HQ, Inc. | 06/12/2013Terminated |