Osteomed LP
Medical device manufacturer in Addison, TX.
73510(k) clearances
0PMA approvals
16recalls
Device types
- HWC Screw, Fixation, Bone 15
- HRS Plate, Fixation, Bone 12
- MQN External Mandibular Fixator And/Or Distractor 7
- JEY Plate, Bone 7
- DZL Screw, Fixation, Intraosseous 5
- KWD Prosthesis, Toe, Hemi-, Phalangeal 3
- KMW Handpiece, Rotary Bone Cutting 2
- KWH Prosthesis, Toe, Constrained, Polymer 2
- DZE Implant, Endosseous, Root-Form 2
- PBJ Cranial Distraction System 2
- KCT Sterilization Wrap Containers, Trays… 2
- HTY Pin, Fixation, Smooth 1
- JDW Pin, Fixation, Threaded 1
- KIJ Instrument, Surgical, Orthopedic… 1
- LZJ Prosthesis, Toe (Metatarsophalangeal)… 1
- EFB Handpiece, Air-Powered, Dental 1
- GXN Plate, Cranioplasty, Preformed, Non-Alterable 1
- NEI Prosthesis, Condyle, Mandibular, Temporary 1
- KWP Appliance, Fixation, Spinal Interlaminal 1
- MRW System, Facet Screw Spinal Device 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K212570 | OsteoPlan SystemDZJ · Traditional | 02/11/2022SE |
| K203479 | ExtremiLOCK Lateral Ankle Fusion PlatesHRS · Traditional | 02/24/2021SE |
| K202105 | OsteoMed ExtremiFix Mini & Small System TrayKCT · Traditional | 10/29/2020SE |
| K202680 | OsteoMed ExtremiFix Mini & Small Cannulated Screw SystemHWC · Special | 10/15/2020SE |
| K173391 | OsteoMed QuickFix Hybrid MMF Sterilization TrayKCT · Traditional | 05/10/2018SE |
| K162542 | OsteoMed PINNACLE DriverHBE · Traditional | 05/19/2017SE |
| K163303 | OsteoMed ExtremiFix Mid and Large Screw SystemHWC · Traditional | 04/04/2017SE |
| K162544 | OsteoMed PINNACLE DriverKMW · Traditional | 04/04/2017SE |
| K161041 | OsteoMed ExtremiLOCK Wrist Plating SystemHRS · Special | 05/19/2016SE |
| K152145 | OsteoMed ExtremiLOCK Wrist Plating SystemHRS · Traditional | 12/21/2015SE |
| K151195 | OsteoMed IMF ScrewDZL · Traditional | 09/21/2015SE |
| K151021 | OsteoMed Cannulated Screw SystemHWC · Special | 07/15/2015SE |
| K143338 | Argulated Locking PlatesJEY · Special | 04/01/2015SE |
| K140978 | Osteomed Low Profile Orbital Floor Plate SystemJEY · Traditional | 12/18/2014SE |
| K140283 | Osteomed Extremifuse SystemHWC · Special | 02/28/2014SE |
| K133691 | Extrimilock Ankle Plating SystemHRS · Traditional | 02/24/2014SE |
| K131851 | Osteomed Neuro RongeurHAE · Traditional | 12/06/2013SE |
| K133437 | 1ST MTP PlateHRS · Special | 12/02/2013SE |
| K131445 | Osteomed Extremilock Foot Plating SystemHRS · Special | 06/18/2013SE |
| K123885 | Osteomed Smartflex Cranial Spring DistractorPBJ · Traditional | 06/03/2013SE |
| K130412 | Osteomed Extremifuse SystemHWC · Traditional | 05/31/2013SE |
| K123207 | Primalif TM Llif Unitary PEEK Lateral Lumbar Interbody Fusion SystemMAX · Traditional | 11/29/2012SE |
| K121304 | Osteomed Cranial Distraction SystemPBJ · Traditional | 08/22/2012SE |
| K120015 | Osteomed Wrist Plating SystemHRS · Traditional | 04/24/2012SE |
| K111419 | Osteomed Hand Fusion SystemHRS · Traditional | 10/07/2011SE |
| K111176 | Osteomed Low Profile Neuro Fixation SystemGWO · Special | 08/15/2011SE |
| K102438 | Primalok Facet Fixation SystemMRW · Traditional | 09/30/2010SE |
| K100354 | Primal Ok Interspinous Fusion SystemKWP · Traditional | 08/17/2010SE |
| K091614 | Osteomed Foot Plating SystemHRS · Traditional | 09/10/2009SE |
| K090522 | Osteomed Hand Plate and Screw Fixation SystemHRS · Traditional | 07/02/2009SE |
| K081876 | Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite CoatingKWD · Special | 08/01/2008SE |
| K080694 | Osteomed Modular Locking Fixation SystemJEY · Traditional | 05/15/2008SE |
| K073065 | Osteomed Metatarsal Resurfacing Implant SystemKWD · Traditional | 02/21/2008SE |
| K071105 | Osteomed Calcaneal Plate and Screw Fixation SystemHRS · Traditional | 07/30/2007SE |
| K063792 | Osteomed External Mandibular Distraction SystemMQN · Traditional | 03/02/2007SE |
| K063298 | Osteomed Headless Cannulated Screw SystemHWC · Traditional | 03/02/2007SE |
| K062851 | Osteomed Pediatric Intraoral Mandibular Distraction System, ExtendedMQN · Traditional | 11/17/2006SE |
| K062863 | Osteomed Extended 2.0/2.4CANNULATED Screw SystemHWC · Traditional | 10/31/2006SE |
| K060536 | Osteomed 1ST MPJ Hemi Implant SystemKWD · Traditional | 06/02/2006SE |
| K051798 | Osteomed Orthodontic Anchor Plating SystemDZE · Traditional | 04/07/2006SE |
| K043434 | Osteomed Pediatric Intraoral Mandibular Distraction SystemMQN · Traditional | 02/10/2005SE |
| K031701 | Osteomed Temporary Condylar Attachment SystemNEI · Traditional | 07/08/2004SE |
| K031936 | Osteomed Orthodontic Screw SystemDZE · Traditional | 01/07/2004SE |
| K031708 | Osteomed Maxillary/Lefort III Distraction SystemMQN · Traditional | 11/03/2003SE |
| K030790 | Osteomed Alveolar Distraction SystemMQN · Traditional | 09/10/2003SE |
| K031155 | Osteomed Subtalar Implant SystemHWC · Traditional | 08/22/2003SE |
| K030448 | Osteomed 2.0 Locking Plates and ScrewsJEY · Traditional | 05/09/2003SE |
| K022277 | Osteomed Cranial Flap Fixation SystemGXN · Traditional | 04/01/2003SE |
| K022887 | Interphalangeal Flexible Stabilizing Rod SystemKWH · Traditional | 11/26/2002SE |
| K022886 | Metatarsophalangeal Flexible Stabilizing Rod SystemKWH · Traditional | 11/25/2002SE |
| K023260 | 1.2MM Osteomed Auto-Drive Screw SystemHWC · Traditional | 10/18/2002SE |
| K013618 | Intraoral Mandibular Distraction SystemMQN · Traditional | 08/14/2002SE |
| K021618 | Osa Rigid Internal Fixation SystemJEY · Traditional | 08/08/2002SE |
| K012486 | Osteomed Bioresorbable Fixation SystemDZL · Traditional | 01/16/2002SE |
| K010964 | Auto-Drive Lag Screw SystemHWC · Traditional | 07/05/2001SE |
| K010783 | 2.0/2.4 Cannulated Screw SystemHWC · Traditional | 05/30/2001SE |
| K990944 | Osteomed Intraoral Distraction SystemMQN · Traditional | 06/16/1999SE |
| K974785 | Auto-Drive Bone ScrewHWC · Traditional | 03/18/1998SE |
| K962774 | Osteomed QuickfixDZL · Traditional | 10/10/1997SE |
| K971692 | Osteopower System and AccessoriesKMW · Traditional | 06/27/1997SE |
| K963394 | Osteomed TramJEY · Traditional | 11/14/1996SE |
| K961418 | Osteomed MSSDZL · Traditional | 10/25/1996SE |
| K954330 | Super Screw 3.5 MMHWC · Traditional | 12/08/1995SE |
| K932352 | Orthopedic Bone PlateHRS · Traditional | 07/05/1995SE |
| K932350 | Orthopedic Screw FixationHWC · Traditional | 07/05/1995SE |
| K933101 | The Osteomed B Power System and AccessoriesKIJ · Traditional | 11/07/1994SE |
| K932349 | Orthopedic Threaded Pin FixationJDW · Traditional | 03/01/1994SE |
| K932348 | Orthopedic Smooth Pin FixationHTY · Traditional | 03/01/1994SE |
| K922211 | Osteomed Great Toe SystemLZJ · Traditional | 11/09/1993SN |
| K924018 | M3 Lag Screw Fixation SystemHWC · Traditional | 04/01/1993SE |
| K924138 | Osteomed M3 System (SBF System)JEY · Traditional | 02/17/1993SE |
| K911936 | Osteomed SBF System (SBF)DZL · Traditional | 08/21/1991SE |
| K911937 | Osteomed Ib DrillEFB · Traditional | 06/10/1991SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2108-2023 Class II | REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, SterileScrews for osteotomies have contain an undersize screwhead which has the potential to pass through the plate… | 05/31/2023Open, Classified |
| Z-2107-2023 Class II | REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, SterileScrews for osteotomies have contain an undersize screwhead which has the potential to pass through the plate… | 05/31/2023Open, Classified |
| Z-0335-2022 Class II | OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00…Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result… | 10/28/2021Open, Classified |
| Z-2191-2020 Class II | OSTEOVATION RMX 10 CC Injectable. REF/UDI: 390-6002/ /00813845021099 - Product Usage:…Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for… | 04/02/2020Terminated |
| Z-2190-2020 Class II | OSTEOVATION 10 CC IMPACT FORMULA. REF/UDI: 390-2110/ /00813845021092 - Product Usage:…Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for… | 04/02/2020Terminated |
| Z-2189-2020 Class II | OSTEOVATION RMX Injectable BVF 5CC . REF/UDI: 390-6001/ /00813845021082 - Product Usage:…Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for… | 04/02/2020Terminated |
| Z-2188-2020 Class II | OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage: The…Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for… | 04/02/2020Terminated |
| Z-2187-2020 Class II | OSTEOVATION 3CC IMPACTFORMULA. REF/UDI: 390-2103/00813845020078 - Product Usage: The…Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for… | 04/02/2020Terminated |
| Z-2186-2020 Class II | OSTEOVATIONEX 3CC IMPACTFORMULA. REF/UDI: 390-0203/00813845020030 - Product Usage: The…Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for… | 04/02/2020Terminated |
| Z-2185-2020 Class II | OSTEOVATIONEX 5CC IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - Product Usage: The…Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for… | 04/02/2020Terminated |
| Z-2184-2020 Class II | OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usage: The…Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for… | 04/02/2020Terminated |
| Z-2183-2020 Class II | OSTEOVATION 5CC INJECT FORMULA. REF/UDI: 390-2005/00813845020054 - Product Usage: The…Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for… | 04/02/2020Terminated |
| Z-2182-2020 Class II | OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product Usage: The…Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for… | 04/02/2020Terminated |
| Z-2181-2020 Class II | OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product Usage: The…Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for… | 04/02/2020Terminated |
| Z-2180-2020 Class II | OSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - Product Usage: The…Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for… | 04/02/2020Terminated |
| Z-0008-2012 | OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed…Two of the Implant Driver Assembly tips were reported to break during surgery. | 06/07/2011Terminated |