K2M, Inc
Leesburg, VA, US
K2M, INC. appears in FDA device records in Leesburg, VA. FDA records list 123 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 39 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 123FDA records hold 123 510(k) clearances for K2M, Inc between 2005 and 2026. The busiest year on record is 2015, with 13. The most recent is 2026, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 4 |
| 2006 | 2 |
| 2007 | 3 |
| 2008 | 8 |
| 2009 | 5 |
| 2010 | 6 |
| 2011 | 10 |
| 2012 | 11 |
| 2013 | 9 |
| 2014 | 11 |
| 2015 | 13 |
| 2016 | 8 |
| 2017 | 10 |
| 2018 | 12 |
| 2019 | 3 |
| 2020 | 4 |
| 2022 | 1 |
| 2026 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260546 | Q Pedicle Instruments | OLO | Substantially Equivalent | |
| K253545 | Vulcan Spinal System | NKB | Substantially Equivalent | |
| K252873 | Q Interbody Instruments | OLO | Substantially Equivalent | |
| K211320 | CAPRI Corpectomy Cage System | PLR | Substantially Equivalent | |
| K202528 | Cannulated Power Driver Attachment | NKB | Substantially Equivalent | |
| K201006 | K2M Navigation Instruments | OLO | Substantially Equivalent | |
| K193203 | MOJAVE Expandable Interbody System | MAX | Substantially Equivalent | |
| K193129 | Yukon OCT Spinal System | NKG | Substantially Equivalent | |
| K192911 | Brainlab Compatible K2M Navigation Instruments | OLO | Substantially Equivalent | |
| K190179 | SAHARA Stabilization System | OVD | Substantially Equivalent | |
| K190584 | CAYMAN LP Plate System | KWQ | Substantially Equivalent | |
| K182473 | PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems | KWQ | Substantially Equivalent | |
| K180665 | SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System | MQP | Substantially Equivalent | |
| K182182 | YUKON OCT Spinal System | NKG | Substantially Equivalent | |
| K181890 | Brainlab Compatible K2M Navigation Instruments | OLO | Substantially Equivalent | |
| K181603 | EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System | NKG | Substantially Equivalent | |
| K180777 | K2M Expandable Interbody System | MAX | Substantially Equivalent | |
| K181119 | Range (Denali and Mesa) Spinal Systems | NKB | Substantially Equivalent | |
| K181188 | EVEREST Spinal System | NKB | Substantially Equivalent | |
| K180376 | K2M Patient Specific Rods | NKB | Substantially Equivalent | |
| K172941 | CASCADIA Interbody System | OVD | Substantially Equivalent | |
| K171556 | K2M Navigation Instruments | OLO | Substantially Equivalent | |
| K173508 | Everest Spinal System | NKB | Substantially Equivalent | |
| K172009 | Cascadia Interbody System | MAX | Substantially Equivalent | |
| K171832 | Range/Denali/Mesa Spinal System | NKB | Substantially Equivalent | |
| K171704 | CAPRI Corpectomy Cage System | MQP | Substantially Equivalent | |
| K171321 | K2M Navigation Instruments | OLO | Substantially Equivalent | |
| K172104 | Ozark(tm) Cervical Plate System | KWQ | Substantially Equivalent | |
| K171444 | YUKON OCT Spinal System | NKG | Substantially Equivalent | |
| K171097 | MOJAVE Expandable Interbody System | MAX | Substantially Equivalent | |
| K170055 | CAPRI Corpectomy Cage System | MQP | Substantially Equivalent | |
| K161332 | NILE Proximal Fixation Spinal System | OWI | Substantially Equivalent | |
| K163364 | MOJAVE Expandable Interbody System | MAX | Substantially Equivalent | |
| K162664 | Pyrenees Cervical Plate System | KWQ | Substantially Equivalent | |
| K162264 | Cascadia Interbody System | MAX | Substantially Equivalent | |
| K161028 | K2M Growing Spine System | PGM | Substantially Equivalent | |
| K153526 | Pyrenees Cervical Plate System | KWQ | Substantially Equivalent | |
| K160125 | Cascadia Interbody System | ODP | Substantially Equivalent | |
| K160547 | Cascadia Interbody System | MAX | Substantially Equivalent | |
| K160208 | NILE Alternative Fixation Spinal System | OWI | Substantially Equivalent | |
| K152872 | K2M Fenestrated Tap System | KNW | Substantially Equivalent | |
| K151481 | Sahara Stabilization System | OVD | Substantially Equivalent | |
| K152281 | Pyrenees Cervical Plate System | KWQ | Substantially Equivalent | |
| K151727 | Everest Spinal System | NKB | Substantially Equivalent | |
| K152015 | Pyrenees Cervical Plate System | KWQ | Substantially Equivalent | |
| K150481 | Cascadia Interbody System | MAX | Substantially Equivalent | |
| K151216 | Everest Spinal System | NKB | Substantially Equivalent | |
| K150983 | Pyrenees Cervical Plate System | KWQ | Substantially Equivalent | |
| K142487 | Chesapeake Stabilization System | OVD | Substantially Equivalent | |
| K142212 | Pyrenees Cervical Plate System | KWQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004774118 | 3008599177 | K2M, INC. | 600 Hope Pkwy SE, Leesburg, VA 20175 US | 2026 | and 36 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HWJAwl
- HXWBender
- HTWBit, Drill
- OWIBone Fixation Cerclage, Sublaminar
- HXYBrace, Drill
- KTZCaliper
- JDQCerclage, Fixation
- HXZCutter, Wire
- ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- HWBExtractor
- MQVFiller, Bone Void, Calcium Compound
- HXEFork
- HTJGauge, Depth
- PGMGrowing Rod System
- HWAImpactor
- OARInjector, Vertebroplasty (Does Not Contain Cement)
- KNWInstrument, Biopsy
- HWNInstrument, Compression
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- HTSKnife, Orthopedic
- LXHOrthopedic Manual Surgical Instrument
- OLOOrthopedic Stereotaxic Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- HXIPasser, Wire, Orthopedic
- OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
- NKGPosterior Cervical Screw System
- HXBProbe
- MJOProsthesis, Intervertebral Disc
- HTXRongeur
- HXXScrewdriver
- PWGSpinal Fixation System
- MQPSpinal Vertebral Body Replacement Device
- PLRSpinal Vertebral Body Replacement Device - Cervical
- HXGTamp
- HWXTap, Bone
- HWTTemplate
- NKBThoracolumbosacral Pedicle Screw System
- FSMTray, Surgical, Instrument
- HXCWrench
Recall records
Showing 25 of 39| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1307-2022 | Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments. | Some of the rods in this lot were observed to have discoloration, later confirmed to be indication of trace amounts of inorganic phosphorous compound. This may produce a mild irritating or inflammatory response; adverse local tissue reactions may occur related to cytotoxicity with the nonconforming rod and surrounding tissue. | Class II | Open, Classified | |
| Z-0706-2022 | Everest MI XT Outer Dilator, Catalog Number 5101-90168 | Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance. | Class II | Open, Classified | |
| Z-0705-2022 | Everest MI XT Inner Dilator, Catalog Number 5101-90167 | Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance. | Class II | Open, Classified | |
| Z-0104-2022 | Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068 | Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requiring intraoperative removal or revision surgery. | Class II | Terminated | |
| Z-1697-2021 | Cascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as anadjunct to fusion in patients with degenerative disc disease. | Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm | Class II | Terminated | |
| Z-1696-2021 | Cascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as anadjunct to fusion in patients with degenerative disc disease. | Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm | Class II | Terminated | |
| Z-1695-2021 | Cascadia AN Interbody Convex 10x22x14mm Catalog Number: 6101-2102214NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as anadjunct to fusion in patients with degenerative disc disease. | Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm | Class II | Terminated | |
| Z-1410-2021 | Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catalog number: 3608-90033 | Interference condition between the 10mm Drill Guide Inserter and the inner shaft that mates with the inserters. As a result, inner shafts do not mate flush with the collet inserters, and splaying of the collet. If implant falls into the spinal cord may cause a spinal cord injury or Incomplete seating of the inserter to the implant could result in misalignment of the screws with the inserter screw guide, potentially causing malposition of the screws into the adjacent vertebral bodies | Class II | Terminated | |
| Z-0931-2021 | Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System | The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length). | Class II | Terminated | |
| Z-0542-2021 | Everest MI XT Tab Removal Tool (i.e. All-In-One Tab Removal Tool)-used to break the tab off the Everest XT screw by rocking the instrument back and forth until the entire tab is fully detached from the screw head. Catalog number: 5101-90195 | All-in-One Tab Removal Tool may cause cracking and/or separating at the threaded interface between tool s metal shaft component and handle, resulting in leakage of Loctite from handle cracks | Class II | Terminated | |
| Z-0520-2021 | Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment Tube ) provides counter rotation to reduce the torque applied to the anatomy when the size 15 Torque limiting shaft (the shaft is used to tighten the Yukon Set Screw to the specified torque. | Shafts do not pass through the inner cannula of the Anti-Torque Alignment Tube from Lot KTGG due to a manufacturing nonconformance. This could result in a delay of surgery or result in surgical intervention later on. | Class II | Terminated | |
| Z-2031-2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90181, UDI # 10888857108943, Size 28x8mm, 18 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy. | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure. | Class II | Terminated | |
| Z-2030-2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90179, UDI # 10888857108929, Size 28x6mm, 18 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy. | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure. | Class II | Terminated | |
| Z-2029-2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90177, UDI # 10888857108905, Size 28x4mm, 18 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy. | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure. | Class II | Terminated | |
| Z-2028-2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90169, UDI # 10888857108820, Size 28x10mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy. | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure. | Class II | Terminated | |
| Z-2027-2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90167, UDI # 10888857108806, Size 28x8mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy. | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure. | Class II | Terminated | |
| Z-2026-2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90165, UDI # 10888857108783, Size 28x6mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy. | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure. | Class II | Terminated | |
| Z-2025-2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90163, UDI # 10888857108769, Size 28x4mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy. | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure. | Class II | Terminated | |
| Z-2024-2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90157, UDI # 10888857108707, Size 28x12mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy. | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure. | Class II | Terminated | |
| Z-2023-2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90155, UDI # 10888857108684, Size 28x10mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy. | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure. | Class II | Terminated | |
| Z-2022-2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90153, UDI # 10888857108660, Size 28x8mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy. | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure. | Class II | Terminated | |
| Z-2021-2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90151, UDI # 10888857108646, Size 28x6mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy. | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure. | Class II | Terminated | |
| Z-2020-2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90149, UDI # 10888857108622, Size 28x4mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy. | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure. | Class II | Terminated | |
| Z-2019-2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90139, UDI # 10888857108523, Size 24x8mm, 18 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy. | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure. | Class II | Terminated | |
| Z-2018-2020 | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90137, UDI # 10888857108509, Size 24x6mm, 18 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy. | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain