K2m, Inc.
Medical device manufacturer in Leesburg, VA.
127510(k) clearances
0PMA approvals
39recalls
Device types
- KWQ Appliance, Fixation, Spinal Intervertebral… 20
- NKB Thoracolumbosacral Pedicle Screw System 20
- MNI Orthosis, Spinal Pedicle Fixation 15
- MAX Intervertebral Fusion Device With Bone… 13
- KWP Appliance, Fixation, Spinal Interlaminal 12
- MQP Spinal Vertebral Body Replacement Device 8
- OVD Intervertebral Fusion Device With… 7
- OLO Orthopedic Stereotaxic Instrument 7
- OSH Pedicle Screw Spinal System, Adolescent… 6
- NKG Posterior Cervical Screw System 5
- MNH Orthosis, Spondylolisthesis Spinal Fixation 3
- ODP Intervertebral Fusion Device With Bone… 3
- OWI Bone Fixation Cerclage, Sublaminar 3
- PLR Spinal Vertebral Body Replacement Device -… 1
- PGM Growing Rod System 1
- KNW Instrument, Biopsy 1
- OVE Intervertebral Fusion Device With… 1
- JDQ Cerclage, Fixation 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K260546 | Q Pedicle InstrumentsOLO · Special | 03/17/2026SE |
| K253545 | Vulcan Spinal SystemNKB · Traditional | 02/10/2026SE |
| K252873 | Q Interbody InstrumentsOLO · Traditional | 02/06/2026SE |
| K211320 | CAPRI Corpectomy Cage SystemPLR · Traditional | 02/24/2022SE |
| K202528 | Cannulated Power Driver AttachmentNKB · Traditional | 10/26/2020SE |
| K201006 | K2M Navigation InstrumentsOLO · Special | 08/07/2020SE |
| K193203 | MOJAVE Expandable Interbody SystemMAX · Special | 02/18/2020SE |
| K193129 | Yukon OCT Spinal SystemNKG · Traditional | 02/07/2020SE |
| K192911 | Brainlab Compatible K2M Navigation InstrumentsOLO · Special | 11/14/2019SE |
| K190179 | SAHARA Stabilization SystemOVD · Traditional | 10/03/2019SE |
| K190584 | CAYMAN LP Plate SystemKWQ · Traditional | 05/15/2019SE |
| K182473 | PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…KWQ · Traditional | 12/12/2018SE |
| K180665 | SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemMQP · Traditional | 11/28/2018SE |
| K182182 | YUKON OCT Spinal SystemNKG · Traditional | 11/15/2018SE |
| K181890 | Brainlab Compatible K2M Navigation InstrumentsOLO · Traditional | 11/09/2018SE |
| K181603 | EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…NKG · Traditional | 10/05/2018SE |
| K180777 | K2M Expandable Interbody SystemMAX · Traditional | 08/03/2018SE |
| K181119 | Range (Denali and Mesa) Spinal SystemsNKB · Traditional | 06/26/2018SE |
| K181188 | EVEREST Spinal SystemNKB · Special | 05/30/2018SE |
| K180376 | K2M Patient Specific RodsNKB · Traditional | 04/05/2018SE |
| K172941 | CASCADIA Interbody SystemOVD · Traditional | 02/12/2018SE |
| K171556 | K2M Navigation InstrumentsOLO · Traditional | 01/16/2018SE |
| K173508 | Everest Spinal SystemNKB · Traditional | 01/09/2018SE |
| K172009 | Cascadia Interbody SystemMAX · Traditional | 12/14/2017SE |
| K171832 | Range/Denali/Mesa Spinal SystemNKB · Traditional | 09/14/2017SE |
| K171704 | CAPRI Corpectomy Cage SystemMQP · Traditional | 08/31/2017SE |
| K171321 | K2M Navigation InstrumentsOLO · Traditional | 08/30/2017SE |
| K172104 | Ozark(tm) Cervical Plate SystemKWQ · Traditional | 08/23/2017SE |
| K171444 | YUKON OCT Spinal SystemNKG · Traditional | 08/08/2017SE |
| K171097 | MOJAVE Expandable Interbody SystemMAX · Special | 05/10/2017SE |
| K170055 | CAPRI Corpectomy Cage SystemMQP · Traditional | 04/13/2017SE |
| K161332 | NILE Proximal Fixation Spinal SystemOWI · Traditional | 04/05/2017SE |
| K163364 | MOJAVE Expandable Interbody SystemMAX · Traditional | 03/15/2017SE |
| K162664 | Pyrenees Cervical Plate SystemKWQ · Special | 10/07/2016SE |
| K162264 | Cascadia Interbody SystemMAX · Special | 09/21/2016SE |
| K161028 | K2M Growing Spine SystemPGM · Traditional | 07/22/2016SE |
| K161369 | EVEREST Spinal SystemNKB · Special | 07/21/2016SE |
| K153526 | Pyrenees Cervical Plate SystemKWQ · Traditional | 04/27/2016SE |
| K160125 | Cascadia Interbody SystemODP · Traditional | 04/22/2016SE |
| K160547 | Cascadia Interbody SystemMAX · Special | 03/24/2016SE |
| K160208 | NILE Alternative Fixation Spinal SystemOWI · Special | 03/18/2016SE |
| K153370 | Caspian OCT/MESA Mini/DENALI Mini Spinal SystemNKG · Traditional | 02/16/2016SE |
| K152872 | K2M Fenestrated Tap SystemKNW · Traditional | 01/05/2016SE |
| K151481 | Sahara Stabilization SystemOVD · Traditional | 12/21/2015SE |
| K153031 | RANGE/DENALI/MESA Spinal SystemNKB · Special | 11/17/2015SE |
| K152281 | Pyrenees Cervical Plate SystemKWQ · Special | 09/24/2015SE |
| K151727 | Everest Spinal SystemNKB · Traditional | 09/17/2015SE |
| K152015 | Pyrenees Cervical Plate SystemKWQ · Traditional | 09/04/2015SE |
| K150481 | Cascadia Interbody SystemMAX · Traditional | 08/20/2015SE |
| K151216 | Everest Spinal SystemNKB · Traditional | 08/10/2015SE |
| K150983 | Pyrenees Cervical Plate SystemKWQ · Traditional | 07/14/2015SE |
| K142487 | Chesapeake Stabilization SystemOVD · Traditional | 05/07/2015SE |
| K142212 | Pyrenees Cervical Plate SystemKWQ · Traditional | 05/01/2015SE |
| K150325 | Range/Denali/Mesa Spinal SystemNKB · Special | 03/31/2015SE |
| K143350 | Nile Alternative FixationOWI · Traditional | 02/25/2015SE |
| K142360 | Everest Spinal SystemNKB · Traditional | 01/21/2015SE |
| K143334 | Range/Denali/Mesa Spinal SystemNKB · Traditional | 01/09/2015SE |
| K142558 | Caspian OCT/MESA Mini/DENALI Mini Spinal SystemKWP · Special | 12/22/2014SE |
| K142016 | CapriMQP · Traditional | 11/06/2014SE |
| K141873 | Range/Mesa/Denali Spinal SystemNKB · Traditional | 09/08/2014SE |
| K133402 | K2M Modular HooksNKB · Traditional | 07/30/2014SE |
| K141284 | Caspian Spinal SystemKWP · Special | 07/23/2014SE |
| K140765 | Range/Mesa/Denali Spinal SystemNKB · Traditional | 07/10/2014SE |
| K133288 | Caspian Oct Spinal SystemKWP · Traditional | 07/01/2014SE |
| K133494 | Chesapeake Spinal SystemOVD · Traditional | 06/10/2014SE |
| K141147 | Range Spinal SystemNKB · Special | 06/03/2014SE |
| K140529 | Everest Spinal SystemNKB · Special | 05/22/2014SE |
| K133614 | Aleutian Ibf SystemMAX · Traditional | 04/03/2014SE |
| K133944 | Range, Spinal System, Everest Spinal SystemNKB · Traditional | 03/21/2014SE |
| K132757 | Everest Spinal SystemMNI · Traditional | 11/20/2013SE |
| K131533 | Cayman Mi Plate SystemKWQ · Traditional | 11/09/2013SE |
| K132361 | Everest Spinal SystemMNI · Traditional | 10/03/2013SE |
| K131784 | Range Spinal SystemOSH · Special | 08/30/2013SE |
| K130699 | Aleutian Spinal SystemMAX · Special | 05/30/2013SE |
| K131030 | Range Spinal SystemOSH · Special | 05/09/2013SE |
| K122877 | Range Spinal System, Small StatureOSH · Special | 05/08/2013SE |
| K130330 | Range Spinal SystemOSH · Special | 05/02/2013SESU |
| K123412 | Range Spinal System, Small Strature ComponentsOSH · Special | 02/13/2013SESU |
| K121630 | Range Spinal SystemOSH · Traditional | 09/11/2012SESU |
| K121808 | Casian, 3.5/4.5 ConnectorsKWP · Special | 07/20/2012SE |
| K121016 | Range Spinal System (Mesa and Denali)MNH · Special | 06/27/2012SE |
| K120899 | Range Spinal System, Unit RodMNI · Special | 05/25/2012SE |
| K120099 | Range Spinal System (Mesa and Denali)MNI · Special | 05/18/2012SE |
| K120656 | Everest Spinal SystemMNI · Special | 04/04/2012SE |
| K120031 | Chesapeake Spinal SystemOVD · Special | 03/16/2012SE |
| K111294 | Santorini Spinal SystemMQP · Traditional | 01/27/2012SE |
| K113329 | K2M, Pyrenees Cervical Plate SystemKWQ · Special | 01/17/2012SE |
| K113654 | CaspianKWP · Special | 01/12/2012SE |
| K113138 | Aleutian SystemMAX · Special | 01/10/2012SE |
| K112920 | Range Spinal System (Mesa and Denali)MNI · Special | 12/21/2011SE |
| K112037 | Range Spinal System (Mesa and Denali)MNI · Special | 10/06/2011SE |
| K111439 | Chesapeake (Cervical Components)OVE · Traditional | 08/24/2011SE |
| K111135 | Pyrenees Cervical Plate System (Translational Plates)KWQ · Special | 08/17/2011SE |
| K110991 | Mesa Spinal System (Keystone Rods)MNI · Special | 08/02/2011SE |
| K110843 | Aleutian Spacer SystemMAX · Special | 06/22/2011SE |
| K103797 | K2M Cocr WireJDQ · Traditional | 05/20/2011SE |
| K103440 | Everest Spinal SystemMNI · Traditional | 03/17/2011SE |
| K103169 | AleuttianODP · Special | 03/07/2011SE |
| K103232 | Caspian Spinal SystemKWP · Special | 01/13/2011SE |
| K101084 | Caspian Spinal SystemKWP · Traditional | 10/04/2010SE |
| K100851 | Range Spinal SystemMNI · Traditional | 08/02/2010SE |
| K101302 | Aleutian Ibf SystemODP · Special | 07/22/2010SE |
| K092474 | Pyrenees Cervical Plate System, Semi-Constrained ScrewsKWQ · Traditional | 03/11/2010SE |
| K092211 | Chesapeake Spinal SystemOVD · Traditional | 03/05/2010SE |
| K100061 | Cayman Screws Model K2-12-1000-XX, K2-12-1001-XXKWQ · Special | 02/12/2010SE |
| K093534 | Modification to Caspian Spinal SystemKWP · Special | 12/16/2009SE |
| K092640 | Caspian Spinal SystemMNI · Special | 11/06/2009SE |
| K091253 | Thoracolumbar Plate, Model 1208-41FXX, Lumber Plate, Model 1208-41FXXL, Sacral Plate…KWQ · Special | 06/04/2009SE |
| K082698 | Aleutian Ibf SystemMAX · Traditional | 04/21/2009SE |
| K080611 | Mesa Spinal SystemMNH · Special | 03/04/2009SE |
| K082769 | Mesa and Range Spinal SystemsKWP · Special | 12/11/2008SE |
| K081380 | Thoracolumbar, Lumbar and Sacral Plates and 6.0 and 7.0 MM Bone ScrewsKWQ · Traditional | 11/19/2008SE |
| K081107 | Caspian Spinal System, Screws, Rods, Hooks, Rod ConnectorsKWP · Traditional | 10/10/2008SE |
| K081381 | Range Spinal System, Large Denali ScrewsMNH · Special | 06/13/2008SE |
| K080792 | K2M Cocr RodMNI · Special | 04/08/2008SE |
| K080302 | Cayman Buttress Plate SystemKWQ · Traditional | 03/24/2008SE |
| K080024 | Aleutian Spacer, Model K2-07-1004-01, K2-07-1005-01MQP · Special | 01/24/2008SE |
| K072914 | Natural Bridge LP Transverse ConnectorsMNI · Traditional | 01/03/2008SE |
| K070229 | Range Spinal SystemMNI · Traditional | 05/03/2007SE |
| K063399 | Aleutian Spacer SystemMQP · Special | 02/23/2007SE |
| K063544 | Modification to Pyrenees Cervical Plate SystemKWQ · Special | 02/14/2007SE |
| K052404 | Denali Deformity SystemKWP · Traditional | 05/23/2006SE |
| K060442 | Pyrenees Cervical Plate SystemKWQ · Traditional | 05/15/2006SE |
| K052398 | Mesa Spinal SystemMNI · Traditional | 12/07/2005SE |
| K051531 | Tectonic Cervical Plate SystemKWQ · Traditional | 10/17/2005SE |
| K051454 | Aleutian Spacer SystemMQP · Traditional | 07/27/2005SE |
| K042635 | Denali Spine SystemKWP · Traditional | 01/10/2005SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1307-2022 Class II | Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and…Some of the rods in this lot were observed to have discoloration, later confirmed to be indication of trace… | 06/13/2022Open, Classified |
| Z-0706-2022 Class II | Everest MI XT Outer Dilator, Catalog Number 5101-90168Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting… | 01/13/2022Open, Classified |
| Z-0705-2022 Class II | Everest MI XT Inner Dilator, Catalog Number 5101-90167Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting… | 01/13/2022Open, Classified |
| Z-0104-2022 Class II | Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument… | 09/08/2021Terminated |
| Z-1697-2021 Class II | Cascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-G2 Lumbar…Mislabeled product labeling references incorrect length or height, or length and height for specific Lots… | 05/07/2021Terminated |
| Z-1696-2021 Class II | Cascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2 Lumbar…Mislabeled product labeling references incorrect length or height, or length and height for specific Lots… | 05/07/2021Terminated |
| Z-1695-2021 Class II | Cascadia AN Interbody Convex 10x22x14mm Catalog Number: 6101-2102214NC-G2 Lumbar…Mislabeled product labeling references incorrect length or height, or length and height for specific Lots… | 05/07/2021Terminated |
| Z-1410-2021 Class II | Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing…Interference condition between the 10mm Drill Guide Inserter and the inner shaft that mates with the… | 03/16/2021Terminated |
| Z-0931-2021 Class II | Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON…The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm… | 12/14/2020Terminated |
| Z-0542-2021 Class II | Everest MI XT Tab Removal Tool (i.e. All-In-One Tab Removal Tool)-used to break the tab…All-in-One Tab Removal Tool may cause cracking and/or separating at the threaded interface between tool s… | 11/04/2020Terminated |
| Z-0520-2021 Class II | Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The…Shafts do not pass through the inner cannula of the Anti-Torque Alignment Tube from Lot KTGG due to a… | 11/03/2020Terminated |
| Z-2031-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | 04/13/2020Terminated |
| Z-2030-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | 04/13/2020Terminated |
| Z-2029-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | 04/13/2020Terminated |
| Z-2028-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | 04/13/2020Terminated |
| Z-2027-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | 04/13/2020Terminated |
| Z-2026-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | 04/13/2020Terminated |
| Z-2025-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | 04/13/2020Terminated |
| Z-2024-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | 04/13/2020Terminated |
| Z-2023-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | 04/13/2020Terminated |
| Z-2022-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | 04/13/2020Terminated |
| Z-2021-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | 04/13/2020Terminated |
| Z-2020-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | 04/13/2020Terminated |
| Z-2019-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | 04/13/2020Terminated |
| Z-2018-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | 04/13/2020Terminated |
| Z-2017-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | 04/13/2020Terminated |
| Z-2016-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | 04/13/2020Terminated |
| Z-2015-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | 04/13/2020Terminated |
| Z-2014-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | 04/13/2020Terminated |
| Z-2013-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | 04/13/2020Terminated |
| Z-2012-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | 04/13/2020Terminated |
| Z-2011-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | 04/13/2020Terminated |
| Z-2010-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | 04/13/2020Terminated |
| Z-2009-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | 04/13/2020Terminated |
| Z-2008-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | 04/13/2020Terminated |
| Z-1492-2019 Class II | Fenestrated Tap Adapter (REF# 5001-90011) Product Usage: The K2M Fenestrated Tap System…The products are mislabeled. | 04/18/2019Terminated |
| Z-1491-2019 Class II | Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015) Product…The products are mislabeled. | 04/18/2019Terminated |
| Z-0110-2020 Class II | YUKON Polyaxial Screws (3.5 X 12 mm, Owning Site: Leesburg USA 3.5 X 14 mm, 3.5 X 32 mm…Screws had a manufacturing error that could prevent the screw from mating with the screw inserter or set… | 07/24/2018Terminated |
| Z-0052-2020 Class II | K2M Special Connector Instruments (Special Connector, Special Adaptor, and Quick…Instruments were developed without adequate consideration given to the need for a new regulatory filing.… | 12/02/2016Terminated |