Data / Medical devices / United States / K2M, Inc.
K2M, Inc.: FDA-registered device maker in Leesburg, VA, United States, 129 510(k) clearances
K2M, Inc. is registered with the FDA (registration 3004774118) in Leesburg, VA, United States. It lists 46 device types. The FDA files 129 510(k) clearances under its listings, the newest dated March 17, 2026. 12 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004774118
- FEI number
- 3008599177
- Address
- 600 Hope Pkwy SE, Leesburg, VA, United States, 20175
- Owner or operator
- VB Spine, LLC (10093189)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- April 11, 2025
- Registered through
- 2026
- Brand names listed
- ADJUSTMENT FORK, ALEUTIAN, ALEUTIAN AN SPACER SYSTEM, ALEUTIAN IBF SYSTEM, ALEUTIAN Interbody Systems Trays, ALEUTIAN SPACER SYSTEM, ALEUTIAN SYSTEM, AVS® AL PEEK Spacer and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Awl | HWJ | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Bender | HXW | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Bone Fixation Cerclage, Sublaminar | OWI | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Brace, Drill | HXY | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Caliper | KTZ | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Cerclage, Fixation | JDQ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Cutter, Wire | HXZ | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Extractor | HWB | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Filler, Bone Void, Calcium Compound | MQV | 2 | Repackager or relabeler | accessdata.fda.gov |
| Fork | HXE | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Growing Rod System | PGM | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Impactor | HWA | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Injector, Vertebroplasty (Does Not Contain Cement) | OAR | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Instrument, Biopsy | KNW | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Instrument, Compression | HWN | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Knife, Orthopedic | HTS | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Orthosis, Spinal Pedicle Fixation | MNI | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Passer, Wire, Orthopedic | HXI | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Posterior Cervical Screw System | NKG | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Probe | HXB | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Prosthesis, Intervertebral Disc | MJO | 3 | Manufacturer for export | accessdata.fda.gov |
| Rongeur | HTX | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Spinal Fixation System | PWG | N | Manufacturer for export | accessdata.fda.gov |
| Spinal Vertebral Body Replacement Device | MQP | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Spinal Vertebral Body Replacement Device - Cervical | PLR | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Tamp | HXG | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Template | HWT | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Wrench | HXC | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 129.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 17, 2026 | K260546 | Q Pedicle Instruments | OLO | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| February 10, 2026 | K253545 | Vulcan Spinal System | NKB | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| February 6, 2026 | K252873 | Q Interbody Instruments | OLO | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| November 7, 2024 | K242361 | OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI | KWQ | Substantially Equivalent | Stryker Spine | accessdata.fda.gov |
| August 27, 2024 | K241517 | Q Guidance System; Mako Spine System; | OLO | Substantially Equivalent | Stryker Leibinger GmbH & Co KG | accessdata.fda.gov |
| June 6, 2024 | K240662 | Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece | OLO | Substantially Equivalent | Stryker Leibinger GmbH & Co KG | accessdata.fda.gov |
| February 14, 2023 | K221490 | Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement System, VLIFT-s Vertebral Body Replacement System, Ascential IBD PEEKc Spacer, Aero-AL Lumbar Cage System, Aero-LL Lumbar Cage System, Aero-C Cervical Cage System, AVS Aria PEEK Spacer, AVS Anchor-C Cervical Cage System, AVS Anchor-L Spacer | ODP | Substantially Equivalent | Stryker Spine | accessdata.fda.gov |
| February 24, 2022 | K211320 | CAPRI Corpectomy Cage System | PLR | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| March 23, 2021 | K203205 | Navigated Spine Instruments | OLO | Substantially Equivalent | Stryker Spine | accessdata.fda.gov |
| October 26, 2020 | K202528 | Cannulated Power Driver Attachment | NKB | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| August 7, 2020 | K201006 | K2M Navigation Instruments | OLO | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| February 7, 2020 | K193129 | Yukon OCT Spinal System | NKG | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| October 3, 2019 | K190179 | SAHARA Stabilization System | OVD | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| May 15, 2019 | K190584 | CAYMAN LP Plate System | KWQ | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| November 28, 2018 | K180665 | SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System | MQP | Substantially Equivalent | K2m, LLC | accessdata.fda.gov |
| November 15, 2018 | K182182 | YUKON OCT Spinal System | NKG | Substantially Equivalent | K2m | accessdata.fda.gov |
| November 9, 2018 | K181890 | Brainlab Compatible K2M Navigation Instruments | OLO | Substantially Equivalent | K2m | accessdata.fda.gov |
| October 5, 2018 | 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 | K2m, Inc. | accessdata.fda.gov |
| June 26, 2018 | K181119 | Range (Denali and Mesa) Spinal Systems | NKB | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| May 30, 2018 | K181188 | EVEREST Spinal System | NKB | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| April 5, 2018 | K180376 | K2M Patient Specific Rods | NKB | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| February 12, 2018 | K172941 | CASCADIA Interbody System | OVD | Substantially Equivalent | K2m | accessdata.fda.gov |
| January 16, 2018 | K171556 | K2M Navigation Instruments | OLO | Substantially Equivalent | K2m | accessdata.fda.gov |
| January 9, 2018 | K173508 | Everest Spinal System | NKB | Substantially Equivalent | K2m | accessdata.fda.gov |
| December 14, 2017 | K172009 | Cascadia Interbody System | MAX | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| September 14, 2017 | K171832 | Range/Denali/Mesa Spinal System | NKB | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| August 31, 2017 | K171704 | CAPRI Corpectomy Cage System | MQP | Substantially Equivalent | K2m | accessdata.fda.gov |
| August 30, 2017 | K171321 | K2M Navigation Instruments | OLO | Substantially Equivalent | K2m | accessdata.fda.gov |
| August 23, 2017 | K172104 | Ozark(tm) Cervical Plate System | KWQ | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| August 8, 2017 | K171444 | YUKON OCT Spinal System | NKG | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| May 10, 2017 | K171097 | MOJAVE Expandable Interbody System | MAX | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| April 13, 2017 | K170055 | CAPRI Corpectomy Cage System | MQP | Substantially Equivalent | K2m | accessdata.fda.gov |
| April 5, 2017 | K161332 | NILE Proximal Fixation Spinal System | OWI | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| March 15, 2017 | K163364 | MOJAVE Expandable Interbody System | MAX | Substantially Equivalent | K2m | accessdata.fda.gov |
| October 7, 2016 | K162664 | Pyrenees Cervical Plate System | KWQ | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| September 21, 2016 | K162264 | Cascadia Interbody System | MAX | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| July 22, 2016 | K161028 | K2M Growing Spine System | PGM | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| July 21, 2016 | K161369 | EVEREST Spinal System | NKB | Substantially Equivalent | K2m, Incorporated | accessdata.fda.gov |
| April 27, 2016 | K153526 | Pyrenees Cervical Plate System | KWQ | Substantially Equivalent | K2m | accessdata.fda.gov |
| April 22, 2016 | K160125 | Cascadia Interbody System | ODP | Substantially Equivalent | K2m | accessdata.fda.gov |
| March 24, 2016 | K160547 | Cascadia Interbody System | MAX | Substantially Equivalent | K2m | accessdata.fda.gov |
| March 18, 2016 | K160208 | NILE Alternative Fixation Spinal System | OWI | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| February 16, 2016 | K153370 | Caspian OCT/MESA Mini/DENALI Mini Spinal System | NKG | Substantially Equivalent | K2m, Incorporated | accessdata.fda.gov |
| February 11, 2016 | K152568 | C-VBR | PLR | Substantially Equivalent | Cardinal Spine, LLC | accessdata.fda.gov |
| January 5, 2016 | K152872 | K2M Fenestrated Tap System | KNW | Substantially Equivalent | K2m | accessdata.fda.gov |
| December 21, 2015 | K151481 | Sahara Stabilization System | OVD | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| November 17, 2015 | K153031 | RANGE/DENALI/MESA Spinal System | NKB | Substantially Equivalent | K2m, Incorporated | accessdata.fda.gov |
| September 24, 2015 | K152281 | Pyrenees Cervical Plate System | KWQ | Substantially Equivalent | K2m | accessdata.fda.gov |
| September 17, 2015 | K151727 | Everest Spinal System | NKB | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| September 4, 2015 | K152015 | Pyrenees Cervical Plate System | KWQ | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| August 20, 2015 | K150481 | Cascadia Interbody System | MAX | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| August 10, 2015 | K151216 | Everest Spinal System | NKB | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| July 14, 2015 | K150983 | Pyrenees Cervical Plate System | KWQ | Substantially Equivalent | K2m | accessdata.fda.gov |
| May 7, 2015 | K142487 | Chesapeake Stabilization System | OVD | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| May 1, 2015 | K142212 | Pyrenees Cervical Plate System | KWQ | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| March 31, 2015 | K150325 | Range/Denali/Mesa Spinal System | NKB | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| February 25, 2015 | K143350 | Nile Alternative Fixation | OWI | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| January 21, 2015 | K142360 | Everest Spinal System | NKB | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| January 9, 2015 | K143334 | Range/Denali/Mesa Spinal System | NKB | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| December 22, 2014 | K142558 | Caspian OCT/MESA Mini/DENALI Mini Spinal System | KWP | Substantially Equivalent | K2m | accessdata.fda.gov |
| November 6, 2014 | K142016 | CAPRI | MQP | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| September 8, 2014 | K141873 | RANGE/MESA/DENALI SPINAL SYSTEM | NKB | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| July 30, 2014 | K133402 | K2M MODULAR HOOKS | NKB | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| July 23, 2014 | K141284 | CASPIAN SPINAL SYSTEM | KWP | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| July 10, 2014 | K140765 | RANGE/MESA/DENALI SPINAL SYSTEM | NKB | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| July 1, 2014 | K133288 | CASPIAN OCT SPINAL SYSTEM | KWP | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| June 10, 2014 | K133494 | CHESAPEAKE SPINAL SYSTEM | OVD | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| June 3, 2014 | K141147 | RANGE SPINAL SYSTEM | NKB | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| May 22, 2014 | K140529 | EVEREST SPINAL SYSTEM | NKB | Substantially Equivalent | K2m, LLC | accessdata.fda.gov |
| April 3, 2014 | K133614 | ALEUTIAN IBF SYSTEM | MAX | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| March 21, 2014 | K133944 | RANGE, SPINAL SYSTEM, EVEREST SPINAL SYSTEM | NKB | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| November 20, 2013 | K132757 | EVEREST SPINAL SYSTEM | MNI | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| November 9, 2013 | K131533 | CAYMAN MI PLATE SYSTEM | KWQ | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| October 3, 2013 | K132361 | EVEREST SPINAL SYSTEM | MNI | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| August 30, 2013 | K131784 | RANGE SPINAL SYSTEM | OSH | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| May 30, 2013 | K130699 | ALEUTIAN SPINAL SYSTEM | MAX | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| May 9, 2013 | K131030 | RANGE SPINAL SYSTEM | OSH | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| May 8, 2013 | K122877 | RANGE SPINAL SYSTEM, SMALL STATURE | OSH | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| May 2, 2013 | K130330 | RANGE SPINAL SYSTEM | OSH | Unknown | K2m, Inc. | accessdata.fda.gov |
| February 13, 2013 | K123412 | RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS | OSH | Unknown | K2m, Inc. | accessdata.fda.gov |
| September 11, 2012 | K121630 | RANGE SPINAL SYSTEM | OSH | Unknown | K2m, Inc. | accessdata.fda.gov |
| July 20, 2012 | K121808 | CASIAN, 3.5/4.5 CONNECTORS | KWP | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| June 27, 2012 | K121016 | RANGE SPINAL SYSTEM (MESA AND DENALI) | MNH | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| May 25, 2012 | K120899 | RANGE SPINAL SYSTEM, UNIT ROD | MNI | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| May 18, 2012 | K120099 | RANGE SPINAL SYSTEM (MESA AND DENALI) | MNI | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| April 4, 2012 | K120656 | EVEREST SPINAL SYSTEM | MNI | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| March 16, 2012 | K120031 | CHESAPEAKE SPINAL SYSTEM | OVD | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| January 27, 2012 | K111294 | SANTORINI SPINAL SYSTEM | MQP | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| January 17, 2012 | K113329 | K2M, PYRENEES CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| January 12, 2012 | K113654 | CASPIAN | KWP | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| January 10, 2012 | K113138 | ALEUTIAN SYSTEM | MAX | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| December 21, 2011 | K112920 | RANGE SPINAL SYSTEM (MESA AND DENALI) | MNI | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| October 6, 2011 | K112037 | RANGE SPINAL SYSTEM (MESA AND DENALI) | MNI | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| August 24, 2011 | K111439 | CHESAPEAKE (CERVICAL COMPONENTS) | OVE | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| August 17, 2011 | K111135 | PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES) | KWQ | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| August 2, 2011 | K110991 | MESA SPINAL SYSTEM (KEYSTONE RODS) | MNI | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| June 22, 2011 | K110843 | ALEUTIAN SPACER SYSTEM | MAX | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| May 20, 2011 | K103797 | K2M COCR WIRE | JDQ | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| March 17, 2011 | K103440 | EVEREST SPINAL SYSTEM | MNI | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
| March 7, 2011 | K103169 | ALEUTTIAN | ODP | Substantially Equivalent | K2m, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 13, 2022 | 90462 | Class II | Ongoing | 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. | accessdata.fda.gov |
| January 13, 2022 | 89522 | Class II | Ongoing | 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. | accessdata.fda.gov |
| September 8, 2021 | 88630 | Class II | Terminated | 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. | accessdata.fda.gov |
| May 7, 2021 | 87905 | Class II | Terminated | 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 | Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm | accessdata.fda.gov |
| March 16, 2021 | 87565 | Class II | Terminated | 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 misalignmen | accessdata.fda.gov |
| December 14, 2020 | 87075 | Class II | Terminated | 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). | accessdata.fda.gov |
| November 4, 2020 | 86733 | Class II | Terminated | 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. Catalo | 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 | accessdata.fda.gov |
| November 3, 2020 | 86748 | Class II | Terminated | 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 | 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. | accessdata.fda.gov |
| April 13, 2020 | 85491 | Class II | Terminated | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90107, UDI # 10888857108202, Size 24x4mm, 6 Product Usage: Used to simulate the height of the cage and | 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. | accessdata.fda.gov |
| April 18, 2019 | 82716 | Class II | Terminated | Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015) Product Usage: The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebr | The products are mislabeled. | accessdata.fda.gov |
| July 24, 2018 | 83768 | Class II | Terminated | YUKON Polyaxial Screws (3.5 X 12 mm, Owning Site: Leesburg USA 3.5 X 14 mm, 3.5 X 32 mm, 3.5 X 34 mm, 3.5 X 38 mm, 3.5 X 40 mm, 4.0 X 16 mm, 4.0 X 18 mm, 4.0 X 20 mm, 4.0 X 22 mm, 4.0 X 24 mm, 4.0 X 26 mm, 4.0 X 28 mm, 4 | Screws had a manufacturing error that could prevent the screw from mating with the screw inserter or set screw as intended. This event was reported to FDA as part of Stryker's retrospective review of K2M product field actions; the action was completed in 2018. | accessdata.fda.gov |
| December 2, 2016 | 83777 | Class II | Terminated | K2M Special Connector Instruments (Special Connector, Special Adaptor, and Quick Adaptor) Product Usage: Special Connector Instruments include an additional feature on their shafts that enable surgeon users to combine th | Instruments were developed without adequate consideration given to the need for a new regulatory filing. This event was reported to FDA as part of Stryker's retrospective review of K2M product field actions; recall actions were completed in 2017. | accessdata.fda.gov |
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Updated March 17, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.