Data / Medical devices / United States / Xtant Medical Holdings, Inc.
Xtant Medical Holdings, Inc.: FDA-registered device maker in Belgrade, MT, United States, 75 510(k) clearances
Xtant Medical Holdings, Inc. is registered with the FDA (registration 3005031160) in Belgrade, MT, United States. It lists 56 device types. The FDA files 75 510(k) clearances under its listings, the newest dated August 2, 2024. 22 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005031160
- Address
- 664 Cruiser Lane, Belgrade, MT, United States, 59714
- Owner or operator
- Xtant Medical Holdings, Inc. (10028385)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- January 26, 2009
- Registered through
- 2027
- Brand names listed
- Adaptor, 1/4" Square/Jacobs Chuck, Aranax Anterior Cervical Plating System, Aspect Anterior Cervical Plate System, Awl, Axle Interspinous Fusion System, Axle PEEK Interspinous Fusion System, Axle-X Interspinous Fusion System, BEAST and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Awl | HWJ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bender | HXW | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Brace, Drill | HXY | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Broach | HTQ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Caliper | KTZ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Clamp | HXD | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Curette | HTF | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Device, Percutaneous, Biopsy | MJG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Dissector, Surgical, General & Plastic Surgery | GDI | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Driver, Surgical, Pin | GFC | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Elevator | HTE | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Extractor | HWB | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Filler, Bone Void, Calcium Compound | MQV | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | MBP | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Forceps | HTD | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Fork | HXE | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Guide, Needle, Surgical | GDF | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Impactor | HWA | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Bending Or Contouring | HXP | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Compression | HWN | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Cutting, Orthopedic | HTZ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Knife, Surgical | EMF | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Mallet | HXL | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Orthosis, Spinal Pedicle Fixation | MNI | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | 2 | Specification developer | accessdata.fda.gov |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Osteotome, Manual | GFI | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Pliers, Surgical | HTC | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Posterior Cervical Screw System | NKG | 2 | Manufacturer | accessdata.fda.gov |
| Probe | HXB | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Rasp | HTR | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Retractor | GAD | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Rongeur | HTX | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Sacroiliac Joint Fixation | OUR | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Spinal Vertebral Body Replacement Device | MQP | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Spinous Process Plate | PEK | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| System, Facet Screw Spinal Device | MRW | U | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tamp | HXG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Template | HWT | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Wrench | HXC | 1 | Repackager or relabeler, 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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 2, 2024 | K241892 | Cortera Spinal Fixation System | NKB | Substantially Equivalent | Xtant Medical Holdings, Inc. | accessdata.fda.gov |
| August 19, 2022 | K221403 | Cortera Spinal Fixation System | NKB | Substantially Equivalent | Surgalign Spine Technologies | accessdata.fda.gov |
| January 27, 2022 | K213493 | Fortilink with TiPlus Technology | ODP | Substantially Equivalent | Paradigm Spine | accessdata.fda.gov |
| June 23, 2021 | K211408 | CervAlign® Anterior Cervical Plate System | KWQ | Substantially Equivalent | Pioneer Surgical Technology, Inc. | accessdata.fda.gov |
| January 14, 2020 | K192800 | Streamline TL Spinal Fixation System | NKB | Substantially Equivalent | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | accessdata.fda.gov |
| December 20, 2019 | K192718 | Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology | MAX | Substantially Equivalent | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | accessdata.fda.gov |
| November 26, 2019 | K192396 | Streamline MIS Spinal Fixation System | NKB | Substantially Equivalent | Pioneer Surgical Technology, Inc. | accessdata.fda.gov |
| July 5, 2019 | K190498 | Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System | MAX | Substantially Equivalent | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | accessdata.fda.gov |
| January 17, 2019 | K183060 | CervAlign Anterior Cervical Plate System | KWQ | Substantially Equivalent | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | accessdata.fda.gov |
| May 17, 2018 | K173832 | InTice-C Porous Ti Cervical Interbody System | ODP | Substantially Equivalent | X-Spine Systems, Inc. | accessdata.fda.gov |
| October 23, 2017 | K172343 | Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology | MAX | Substantially Equivalent | Rti Surgical, Inc. | accessdata.fda.gov |
| September 29, 2017 | K170119 | Calix Lumbar Spinal Implant System | MAX | Substantially Equivalent | X-Spine Systems, Inc. | accessdata.fda.gov |
| August 28, 2017 | K171567 | IRIX-A Lumbar Integrated Fusion System | OVD | Substantially Equivalent | X-Spine Systems, Inc. | accessdata.fda.gov |
| August 18, 2017 | K172139 | Streamline OCT Occipito-Cervico-Thoracic System | NKG | Substantially Equivalent | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | accessdata.fda.gov |
| August 1, 2017 | K171075 | Calix-C Cervical Interbody Spacer | ODP | Substantially Equivalent | X-Spine Systems, Inc. | accessdata.fda.gov |
| July 6, 2017 | K170224 | Spider Cervical Plating System | KWQ | Substantially Equivalent | X-Spine Systems, Inc. | accessdata.fda.gov |
| June 28, 2017 | K170830 | Unison-C Anterior Cervical Fixation System | OVE | Substantially Equivalent | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | accessdata.fda.gov |
| May 23, 2017 | K163673 | Fortilink-C with TETRAfuse 3D Technology | ODP | Substantially Equivalent | Rti Surgical, Inc. | accessdata.fda.gov |
| April 14, 2017 | K170643 | Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System | MAX | Substantially Equivalent | Rti Surgical, Inc. Dba Rti Biologics | accessdata.fda.gov |
| November 7, 2016 | K162944 | Irix-C Cervical Integrated Fusion System | OVE | Substantially Equivalent | X-Spine Systems, Inc. | accessdata.fda.gov |
| August 22, 2016 | K161498 | Streamline OCT Occipito-Cervico-Thoracic System | NKG | Substantially Equivalent | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | accessdata.fda.gov |
| March 15, 2016 | K160114 | Xspan Laminoplasty Fixation System | NQW | Substantially Equivalent | X-Spine Systems, Inc. | accessdata.fda.gov |
| January 19, 2016 | K152793 | Unison-C Anterior Cervical Fixation System | OVE | Substantially Equivalent | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | accessdata.fda.gov |
| September 25, 2015 | K152132 | X-spine Pedicle Screw System | MNI | Substantially Equivalent | X-Spine Systems, Inc. | accessdata.fda.gov |
| August 18, 2015 | K150621 | OsteoSelect PLUS Demineralized Bone Matrix Putty | MQV | Substantially Equivalent | Bacterin International, Inc. | accessdata.fda.gov |
| July 10, 2015 | K150834 | Atrax Anterior Cervical Plating System | KWQ | Substantially Equivalent | X-Spine Systems, Inc. | accessdata.fda.gov |
| May 15, 2015 | K150521 | Interbody Fusion (IBF)/Vertebral Body Replacement(VBR) System | ODP | Substantially Equivalent | Rti Surgical, Inc. Dba Rti Biologics | accessdata.fda.gov |
| April 28, 2015 | K150254 | Streamline OCT Occipito-Cervico-Thoracic System | KWP | Substantially Equivalent | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | accessdata.fda.gov |
| October 17, 2014 | K141600 | NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT | MQV | Substantially Equivalent | Pioneer Surgical Technology, Inc. (Rti Surgical, I | accessdata.fda.gov |
| July 29, 2014 | K133947 | IRIX-A LUMBAR INTEGRATED FUSION SYSTEM | OVD | Substantially Equivalent | X-Spine Systems, Inc. | accessdata.fda.gov |
| April 10, 2014 | K140696 | STREAMLINE TL SPINAL FIXATION SYSTEM | NKB | Substantially Equivalent | Pioneer Surgical Technology, Inc. | accessdata.fda.gov |
| March 27, 2014 | K133455 | CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC | MAX | Substantially Equivalent | Pioneer Surgical Technology, Inc. | accessdata.fda.gov |
| March 25, 2014 | K140079 | SILEX SACROILIAC JOINT FUSION SYSTEM | OUR | Substantially Equivalent | X-Spine Systems, Inc. | accessdata.fda.gov |
| March 19, 2014 | K133374 | STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM | KWP | Substantially Equivalent | Pioneer Surgical Technology, Inc. (Rti Surgical, I | accessdata.fda.gov |
| February 10, 2014 | K133623 | C-PLUS | ODP | Substantially Equivalent | Pioneer Surgical Technology, Inc. | accessdata.fda.gov |
| February 7, 2014 | K132050 | NB3D BONE VOID FILLER | MQV | Substantially Equivalent | Pioneer Surgical Technology, Inc. | accessdata.fda.gov |
| December 24, 2013 | K131724 | PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE | MQP | Substantially Equivalent | Pioneer Surgical Technology, Inc. | accessdata.fda.gov |
| October 23, 2013 | K131350 | CALIX LUMBAR SPINAL IMPLANT SYSTEM | MAX | Substantially Equivalent | X-Spine Systems, Inc. | accessdata.fda.gov |
| August 14, 2013 | K131951 | IRIX-C CERVICAL INTEGRATED FUSION SYSTEM | OVE | Substantially Equivalent | X-Spine Systems, Inc. | accessdata.fda.gov |
| June 27, 2013 | K131100 | STREAMLINE TL SPINAL SYSTEM | NKB | Substantially Equivalent | Pioneer Surgical Technology, Inc. | accessdata.fda.gov |
| June 27, 2013 | K130438 | AXLE INTERSPINOUS FUSION SYSTEM | PEK | Substantially Equivalent | X-Spine Systems, Inc. | accessdata.fda.gov |
| June 5, 2013 | K130427 | PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Pioneer Surgical Technology, Inc. | accessdata.fda.gov |
| May 31, 2013 | K130498 | OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY | MBP | Substantially Equivalent | Bacterin International, Inc. | accessdata.fda.gov |
| May 1, 2013 | K123932 | ZYGAFIX SPINAL FACET SCREW SYSTEM | MRW | Substantially Equivalent | X-Spine Systems, Inc. | accessdata.fda.gov |
| April 1, 2013 | K130286 | STREAMLINE MIS SPINAL FIXATION SYSTEM | NKB | Substantially Equivalent | Pioneer Surgical Technology, Inc. | accessdata.fda.gov |
| March 11, 2013 | K123702 | SILEX SACROILIAC JOINT FUSION SYSTEM | OUR | Substantially Equivalent | X-Spine Systems, Inc. | accessdata.fda.gov |
| October 23, 2012 | K120832 | FORTEX PEDICLE SCREW SYSTEM | MNH | Substantially Equivalent | X-Spine Systems, Inc. | accessdata.fda.gov |
| May 7, 2012 | K120724 | PIONEER LATERAL PLATE SYSTEM | KWQ | Substantially Equivalent | Pioneer Surgical Technology, Inc. | accessdata.fda.gov |
| December 5, 2011 | K112592 | AXLE PEEK INTERSPINOUS FUSION SYSTEM | KWP | Substantially Equivalent | X-Spine Systems, Inc. | accessdata.fda.gov |
| November 8, 2011 | K112036 | CALIX PC SPINAL IMPLANT SYSTEM | ODP | Substantially Equivalent | X-Spine Systems, Inc. | accessdata.fda.gov |
| September 28, 2011 | K112496 | PIONEER CROSSFUSE II IBF/VBR SYSTEM | MAX | Substantially Equivalent | Pioneer Surgical Technology, Inc. | accessdata.fda.gov |
| August 24, 2011 | K111528 | PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES | KWQ | Substantially Equivalent | Pioneer Surgical Technology, Inc. | accessdata.fda.gov |
| August 23, 2011 | K111502 | STREAMLINE TL SPINAL SYSTEM | NKB | Substantially Equivalent | Pioneer Surgical Technology, Inc. | accessdata.fda.gov |
| March 7, 2011 | K101790 | QUANTUM SPINAL SYSTEM, QUANTUM MIS | NKB | Substantially Equivalent | Pioneer Surgical Technology | accessdata.fda.gov |
| November 24, 2010 | K101471 | AXLE INTERSPINOUS FUSION SYSTEM | KWP | Substantially Equivalent | X-Spine Systems, Inc. | accessdata.fda.gov |
| August 11, 2010 | K093692 | QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES | NKB | Substantially Equivalent | Pioneer Surgical Technology | accessdata.fda.gov |
| August 10, 2010 | K093771 | QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM | MNH | Substantially Equivalent | Pioneer Surgical Technology | accessdata.fda.gov |
| May 21, 2010 | K100154 | FIXCET SPINAL FACET SCREW SYSTEM | MRW | Substantially Equivalent | X-Spine Systems, Inc. | accessdata.fda.gov |
| September 11, 2009 | K091321 | OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY | MQV | Substantially Equivalent | Bacterin International, Inc. | accessdata.fda.gov |
| July 30, 2009 | K090224 | FORTEX PEDICLE SCREW SYSTEM | MNH | Substantially Equivalent | X-Spine Systems, Inc. | accessdata.fda.gov |
| April 28, 2009 | K090222 | PIONEER LUMBAR PLATE SYSTEM | KWQ | Substantially Equivalent | Pioneer Surgical Technology | accessdata.fda.gov |
| April 20, 2009 | K083637 | CALIX SPINAL IMPLANT SYSTEM | ODP | Substantially Equivalent | X-Spine Systems, Inc. | accessdata.fda.gov |
| February 25, 2009 | K083663 | PACP | KWQ | Substantially Equivalent | Pioneer Surgical Technology | accessdata.fda.gov |
| December 4, 2008 | K071849 | ALLOFUSE GEL AND PUTTY | MQV | Substantially Equivalent | Allosource, Inc. | accessdata.fda.gov |
| October 31, 2008 | K082821 | SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Spine Smith Partners L.P. | accessdata.fda.gov |
| July 14, 2008 | K081132 | SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Spine Smith Partners L.P. | accessdata.fda.gov |
| May 13, 2008 | K073177 | PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM | MAX | Substantially Equivalent | Pioneer Surgical Technology | accessdata.fda.gov |
| March 20, 2008 | K080518 | PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM | NKB | Substantially Equivalent | Pioneer Surgical Technology | accessdata.fda.gov |
| January 10, 2008 | K072703 | PIONEER SLIMFUSE ANTERIOR CERVICAL PLATING SYSTEM | KWQ | Substantially Equivalent | Pioneer Surgical Technology | accessdata.fda.gov |
| July 3, 2007 | K070973 | QUANTUM SPINAL SYSTEM | NKB | Substantially Equivalent | Pioneer Surgical Technology | accessdata.fda.gov |
| March 29, 2007 | K070551 | MODIFICATION TO: PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM | NKB | Substantially Equivalent | Pioneer Surgical Technology | accessdata.fda.gov |
| November 16, 2005 | K053053 | PACP SYSTEM | KWQ | Substantially Equivalent | Pioneer Surgical Technology | accessdata.fda.gov |
| October 21, 2005 | K052292 | SPIDER CERVICAL PLATING (SCP) SYSTEM | KWQ | Substantially Equivalent | X-Spine Systems, Inc. | accessdata.fda.gov |
| February 3, 2005 | K043066 | PIONEER ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Pioneer Surgical Technology | accessdata.fda.gov |
| July 23, 2004 | K041167 | PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM | NKB | Substantially Equivalent | Pioneer Surgical Technology | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 9, 2026 | 98643 | Class II | Ongoing | nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Advanced Bone Graft Substitute, 25x100x8mm, 20cc 90-300-25508: nanOss 3D Advanced Bone Graft Substitute, 25x | Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years. | accessdata.fda.gov |
| February 18, 2026 | 98541 | Class II | Ongoing | XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL. | Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is. | accessdata.fda.gov |
| January 3, 2025 | 96179 | Class II | Ongoing | Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8, 11mm, PC (STERILE)) and Model Number X080-382819-08PC (Spacer ASSY, 38 X 28 X 8, 19mm, PC, (STERILE)) | Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date. | accessdata.fda.gov |
| August 21, 2024 | 95395 | Class II | Ongoing | Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045 | Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released manufacturing specifications, and if implanted the screws may not have adequate strength or performance. | accessdata.fda.gov |
| November 28, 2023 | 93738 | Class II | Ongoing | Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length. | Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm length screws, which if used may lead to the screw not engaging. | accessdata.fda.gov |
| December 29, 2021 | 89367 | Class II | Terminated | X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System. | The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert. | accessdata.fda.gov |
| September 30, 2020 | 86602 | Class III | Terminated | XTANT Medical, ## mm x ## mm x # mm x #,Lordotic/Packaged InTice - C, Sterile R, Single Use Only, for the following Reference numbers/ Primary DI Number/Material Grade on Label: Ref: X098-0106-STR DI Number: M697X0980106 | Cervical Implants contain a label that incorrectly identifies the grade of titanium used. | accessdata.fda.gov |
| May 12, 2020 | 85789 | Class II | Terminated | Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591 | The strike plate fractured off from the forceps inserter devices with minimal impaction or force due to unsatisfactory weld. | accessdata.fda.gov |
| May 3, 2019 | 85036 | Class II | Terminated | OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R, Product Code: 359100, Dimensions: ONE(1) PACKAGE - CONTAINING 10.0cc. UDI: 00849777003681 - Product Usage: OsteoSelect DBM Putty is indica | The firm received one customer complaint concerning three OsteoSelect Demineralized Bone Matrix (DBM) devices which contained 5.0cc of putty, instead of 10.00cc of putty as labeled. | accessdata.fda.gov |
| December 19, 2018 | 81899 | Class II | Terminated | Calix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF ASSY PC, REF X034-0172PC 22mm x 10mm x 8mm PLIF ASSY PC, REF X034-0173PC 26mm x 10mm x 6mm PLIF ASSY PC, REF X034-0240PC 26mm x 10mm x 8mm PLIF ASSY PC, REF X034 | This recall has been initiated due to a change in packaging and sterilization method to address potential risks of compromised sterilization presented by the existing configuration. | accessdata.fda.gov |
| April 12, 2017 | 76842 | Class II | Terminated | 5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in plastic bags with one piece per bag. Product Usage: The 5.5mm dia. X 500 mm CoCr Straight Rod is an accessory to the Fortex Ped | The material type on the label may incorrectly state Ti6Al-4V ELI. The rods are composed of Cobalt Chromium. | accessdata.fda.gov |
| May 17, 2016 | 74397 | Class II | Terminated | Calix P PEEK Lumbar System, PLIF Rasp | The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in the intervertebral space. | accessdata.fda.gov |
| April 7, 2015 | 71357 | Class II | Terminated | Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 | The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length. | accessdata.fda.gov |
| March 11, 2015 | 70774 | Class II | Terminated | Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar connector assemblies. | One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x 55mm instead of 5.5 x 55mm as described on the product label. | accessdata.fda.gov |
| March 9, 2015 | 70744 | Class II | Terminated | Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge SC grafts to fill bone defects in the subchondral region of articulating joints. The Instrument Kit is used to establish | Instrument Kits for OsteoSponge SC grafts, OsteoLock Facet Stabilization Dowel, and BacFast HD Facet Dowel have incorrect sterilization parameters in the IFU and on the lid of the kits. Sterilization parameters for the Steam Gravity 121 degree C (250 F) cycle were not validated and the dry time for the Steam Pre-Vacuum 132 degree C (270 F) cycle was omitted. | accessdata.fda.gov |
| July 11, 2014 | 68863 | Class II | Terminated | Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal sur | Revision B of the tissue shields of the device was 7 mm longer than the previous design. | accessdata.fda.gov |
| May 15, 2014 | 68305 | Class II | Terminated | Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***" Two different sizes, 10 units per box: 19 Fr Round Hubless part number 7110; 24 Fr Round Hubless part number 7118. AC-powered | The recalling firm reported there was inadvertent omission of quarterly (Q4 - 2013 and Q1 - 2014) dose audits/verifications on the affected products. All of the affected products were appropriately sterilized | accessdata.fda.gov |
| February 21, 2013 | 64486 | Class II | Terminated | OsteoSelect DBM Putty Product Usage: Orthopedic bone filler | The firm's retesting procedure was not validated. | accessdata.fda.gov |
| January 28, 2013 | 64326 | Class II | Terminated | Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, Box of 10 Part #7118. Indicated for use in surgical wound drainage. | A portion of a silicone wound drain was found to be cracked. | accessdata.fda.gov |
| April 18, 2012 | 63433 | Class II | Terminated | Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056 2.5cc Expiration Date: 12/25/2011; LBL 210-0010-1 REV: 040109; and Graft ID# B090056-675. Bone void fill | Expired product was shipped to two customers. | accessdata.fda.gov |
| July 15, 2011 | 59756 | Not yet classified | Terminated | Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns, Lot # 525942, S/Ns, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set sc | The firm learned that the Torque Driver Handles were not actuating at a proper torque. It was determined that the handles were speed determinant and could output a higher torque if the handles were turned at a very slow speed. | accessdata.fda.gov |
| March 24, 2009 | 51956 | Not yet classified | Terminated | Capless Li Pedicle Screw System, Diameters - 4.75mm, 5.5mm, 6.5mm, 7.5mm, 8.25mm, Lengths 30mm-55mm, labeled non-sterile. The Capless LI Pedicle Screw System is indicated for the treatment of sever spondylolisthesis of t | A defect cause was discovered following a customer complaint pertaining to a post operative dissociation of the Capless Li Screw construct. The screw assembly is made up of three parts; a cup which locks onto a 5.5mm rod, a yoke that cradles the rod during fusion, and a screw that attached to the vertebra. The screw ball on the screw was manufactured out of | accessdata.fda.gov |
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Updated April 21, 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.