Xtant Medical Holdings, Inc.
Belgrade, MT, US
Xtant Medical Holdings, Inc. appears in FDA device records in Belgrade, MT. FDA records list 40 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 25 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
3 namesFDA records resolved to Xtant Medical Holdings, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Bacterin International, Inc.510(k), enforcement report, recall
- X-Spine Systems, Inc.510(k), enforcement report, recall
- XTANT MEDICAL INCenforcement report, recall
510(k) clearance history
FDA records hold 40 510(k) clearances for Xtant Medical Holdings, Inc. between 2004 and 2024. The busiest year on record is 2013, with 7. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 1 |
| 2005 | 2 |
| 2007 | 2 |
| 2008 | 1 |
| 2009 | 3 |
| 2010 | 3 |
| 2011 | 2 |
| 2012 | 2 |
| 2013 | 7 |
| 2014 | 2 |
| 2015 | 3 |
| 2016 | 4 |
| 2017 | 5 |
| 2018 | 2 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K241892 | Cortera™ Spinal Fixation System | NKB | Substantially Equivalent | |
| K173832 | InTice™-C Porous Ti Cervical Interbody System | ODP | Substantially Equivalent | |
| K180153 | X-spine Cortical Bone Screw System | NKB | Substantially Equivalent | |
| K170119 | Calix Lumbar Spinal Implant System | MAX | Substantially Equivalent | |
| K171567 | IRIX-A Lumbar Integrated Fusion System | OVD | Substantially Equivalent | |
| K171075 | Calix-C Cervical Interbody Spacer | ODP | Substantially Equivalent | |
| K170224 | Spider Cervical Plating System | KWQ | Substantially Equivalent | |
| K170530 | Butrex Lumbar Buttress Plating System | KWQ | Substantially Equivalent | |
| K160959 | Xsert Lumbar Expandable Interbody System | MAX | Substantially Equivalent | |
| K162944 | Irix-C Cervical Integrated Fusion System | OVE | Substantially Equivalent | |
| K160428 | Certex Spinal Fixation System | NKG | Substantially Equivalent | |
| K160114 | Xspan Laminoplasty Fixation System | NQW | Substantially Equivalent | |
| K152132 | X-spine Pedicle Screw System | MNI | Substantially Equivalent | |
| K150621 | OsteoSelect PLUS Demineralized Bone Matrix Putty | MQV | Substantially Equivalent | |
| K150834 | Atrax Anterior Cervical Plating System | KWQ | Substantially Equivalent | |
| K133947 | IRIX-A LUMBAR INTEGRATED FUSION SYSTEM | OVD | Substantially Equivalent | |
| K140079 | SILEX SACROILIAC JOINT FUSION SYSTEM | OUR | Substantially Equivalent | |
| K133094 | CERTEX OCT SPINAL IMPLANT SYSTEM | KWP | Substantially Equivalent | |
| K131350 | CALIX LUMBAR SPINAL IMPLANT SYSTEM | MAX | Substantially Equivalent | |
| K131951 | IRIX-C CERVICAL INTEGRATED FUSION SYSTEM | OVE | Substantially Equivalent | |
| K130438 | AXLE INTERSPINOUS FUSION SYSTEM | PEK | Substantially Equivalent | |
| K130498 | OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY | MBP | Substantially Equivalent | |
| K123932 | ZYGAFIX SPINAL FACET SCREW SYSTEM | MRW | Substantially Equivalent | |
| K123702 | SILEX SACROILIAC JOINT FUSION SYSTEM | OUR | Substantially Equivalent | |
| K122163 | CERTEX SPINAL IMPLANT SYSTEM | MNI | Substantially Equivalent | |
| K120832 | FORTEX PEDICLE SCREW SYSTEM | MNH | Substantially Equivalent | |
| K112592 | AXLE PEEK INTERSPINOUS FUSION SYSTEM | KWP | Substantially Equivalent | |
| K112036 | CALIX PC SPINAL IMPLANT SYSTEM | ODP | Substantially Equivalent | |
| K101471 | AXLE INTERSPINOUS FUSION SYSTEM | KWP | Substantially Equivalent | |
| K100154 | FIXCET SPINAL FACET SCREW SYSTEM | MRW | Substantially Equivalent | |
| K092360 | ACP4 SPINAL IMPLANT SYSTEM | KWQ | Substantially Equivalent | |
| K091321 | OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY | MQV | Substantially Equivalent | |
| K090224 | FORTEX PEDICLE SCREW SYSTEM | MNH | Substantially Equivalent | |
| K083637 | CALIX SPINAL IMPLANT SYSTEM | ODP | Substantially Equivalent | |
| K072943 | BUTREX BUTTRESS PLATING SYSTEM | KWQ | Substantially Equivalent | |
| K063245 | ELUTIA COATED CLOSED SURGICAL WOUND DRAIN | OEI | Substantially Equivalent | |
| K072282 | CAPLESS LI PEDICLE SCREW SYSTEM | MNH | Substantially Equivalent | |
| K052847 | CAPLESS PEDICLE SCREW SYSTEM | MNI | Substantially Equivalent | |
| K052292 | SPIDER CERVICAL PLATING (SCP) SYSTEM | KWQ | Substantially Equivalent | |
| K041469 | ANTERIOR COMPACT SYSTEM | KWQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005031160 | 3005031160 | Xtant Medical Holdings, Inc. | 664 Cruiser Lane, Belgrade, MT 59714 US | 2026 | and 46 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
- HXYBrace, Drill
- HTQBroach
- KTZCaliper
- HXDClamp
- HTFCurette
- MJGDevice, Percutaneous, Biopsy
- GDIDissector, Surgical, General & Plastic Surgery
- OEIDrainage Catheter With Antibiotic
- GFCDriver, Surgical, Pin
- HTEElevator
- HWBExtractor
- MQVFiller, Bone Void, Calcium Compound
- MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)
- HTDForceps
- HXEFork
- HTJGauge, Depth
- GDFGuide, Needle, Surgical
- FZXGuide, Surgical, Instrument
- GDZHandle, Scalpel
- HWAImpactor
- HXPInstrument, Bending Or Contouring
- HWNInstrument, Compression
- HTZInstrument, Cutting, Orthopedic
- 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
- EMFKnife, Surgical
- HXLMallet
- LXHOrthopedic Manual Surgical Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- NQWOrthosis, Spine, Plate, Laminoplasty, Metal
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- GFIOsteotome, Manual
- HTCPliers, Surgical
- NKGPosterior Cervical Screw System
- HXBProbe
- HTRRasp
- GADRetractor
- HTXRongeur
- OURSacroiliac Joint Fixation
- HXXScrewdriver
- MQPSpinal Vertebral Body Replacement Device
- PEKSpinous Process Plate
- MRWSystem, Facet Screw Spinal Device
- HXGTamp
- HWXTap, Bone
- HWTTemplate
- NKBThoracolumbosacral Pedicle Screw System
- LRPTray, Surgical
- HXCWrench
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1897-2026 | 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, 25x50x8mm, 10cc 90-300-251004: nanOss 3D Advanced Bone Graft Substitute, 25x100x4mm, 10cc 90-400-25508: nanOss 3D Plus Advanced Bone Graft Substitute, 25x50x8mm, 10cc | Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years. | Class II | Open, Classified | |
| Z-1773-2026 | 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. | Class II | Open, Classified | |
| Z-1177-2025 | 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. | Class II | Open, Classified | |
| Z-0125-2025 | 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. | Class II | Open, Classified | |
| Z-0846-2024 | 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. | Class II | Open, Classified | |
| Z-0533-2022 | 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. | Class II | Terminated | |
| Z-0429-2021 | 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: M697X0980106STR1 Mat.: CP Ti Grade 3, Ref: X098-0107-STR DI Number: M697X0980107STR1 Mat.: CP Ti Grade 4, Ref: X098-0108-STR DI Number: M697X0980108STR1 Mat.: CP Ti Grade 5, Ref: X098-0109-STR DI Number: M697X0980109STR1 Mat.: CP Ti Grade 6, Ref: X098-0110-STR DI Number: M697X0980110STR1 Mat.: CP Ti Grade 7, Ref: X098-0111-STR DI Number: M697X0980111STR1 Mat.: CP Ti Grade 8, Ref: X098-0112-STR DI Number: M697X0980112STR1 Mat.: CP Ti Grade 9, Ref: X098-0205-STR DI Number: M697X0980205STR1 Mat.: CP Ti Grade 10, Ref: X098-0206-STR DI Number: M697X0980206STR1 Mat.: CP Ti Grade 11, Ref: X098-0207-STR DI Number: M697X0980207STR1 Mat.: CP Ti Grade 12, Ref: X098-0208-STR DI Number: M697X0980208STR1 Mat.: CP Ti Grade 13, Ref: X098-0209-STR DI Number: M697X0980209STR1 Mat.: CP Ti Grade 14, Ref: X098-0210-STR DI Number: M697X0980210STR1 Mat.: CP Ti Grade 15, Ref: X098-0211-STR DI Number: M697X0980211STR1 Mat.: CP Ti Grade 16, Ref: X098-0212-STR DI Number: M697X0980212STR1 Mat.: CP Ti Grade 17, Ref: X098-0305-STR DI Number: M697X0980305STR1 Mat.: CP Ti Grade 18, Ref: X098-0306-STR DI Number: M697X0980306STR1 Mat.: CP Ti Grade 19, Ref: X098-0307-STR DI Number: M697X0980307STR1 Mat.: CP Ti Grade 20, Ref: X098-0308-STR DI Number: M697X0980308STR1 Mat.: CP Ti Grade 21, Ref: X098-0309-STR DI Number: M697X0980309STR1 Mat.: CP Ti Grade 22, Ref: X098-0310-STR DI Number: M697X0980310STR1 Mat.: CP Ti Grade 23, Ref: X098-0311-STR DI Number: M697X0980311STR1 Mat.: CP Ti Grade 24, Ref: X098-0312-STR DI Number: M697X0980312STR1 Mat.: CP Ti Grade 25 | Cervical Implants contain a label that incorrectly identifies the grade of titanium used. | Class III | Terminated | |
| Z-2500-2020 | 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. | Class II | Terminated | |
| Z-1526-2020 | 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 indicated for use as a bone void filler and bone graft substitute for voids or gaps that are not intrinsic to the stability of the bony structure. OsteoSelect DBM Putty is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone. OsteoSelect DBM Putty can be used as follows: - Extremities - Posterolateral spine - Pelvis. | 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. | Class II | Terminated | |
| Z-0790-2019 | 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 X034-0241PC 26mm x 10mm x 10mm PLIF ASSY PC, REF X034-0242PC 26mm x 10mm x 12mm PLIF ASSY PC, REF X034-0243PC 26mm x 10mm x 6mm TLIF ASSY PC, REF X034-0280PC 28mm x 10mm x 7mm TLIF ASSY PC, REF X034-0281PC 28mm x 10mm x 8mm TLIF ASSY PC, REF X034-0282PC 28mm x 10mm x 9mm TLIF ASSY PC, REF X034-0283PC 28mm x 10mm x 10mm TLIF ASSY PC, REF X034-0284PC 28mm x 10mm x 11mm TLIF ASSY PC, REF X034-0285PC 28mm x 10mm x 12mm TLIF ASSY PC, REF X034-0286PC 28mm x 10mm x 13mm TLIF ASSY PC, REF X034-0287PC 28mm x 10mm x 14mm TLIF ASSY PC, REF X034-0288PC 28mm x 10mm x 15mm TLIF ASSY PC, REF X034-0289PC 28mm x 10mm x 16mm TLIF ASSY PC, REF X034-0290PC 26mm x 10mm x 6mm 5o PLIF Assy PC, REF X034-0387PC 26mm x 10mm x 7mm 5o PLIF Assy PC, REF X034-0388PC 26mm x 10mm x 8mm 5o PLIF Assy PC, REF X034-0389PC 26mm x 10mm x 9mm 5o PLIF Assy PC, REF X034-0390PC 26mm x 10mm x 10mm 5o PLIF Assy PC, REF X034-0391PC 26mm x 10mm x 11mm 5o PLIF Assy PC, REF X034-0392PC 26mm x 10mm x 12mm 5o PLIF Assy PC, REF X034-0393PC 26mm x 10mm x 13mm 5o PLIF Assy PC, REF X034-0394PC 26mm x 10mm x 14mm 5o PLIF Assy PC, REF X034-0395PC 26mm x 10mm x 15mm 5o PLIF Assy PC, REF X034-0396PC This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). | 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. | Class II | Terminated | |
| Z-1884-2017 | 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 Pedicle Screw System. It is a straight rod connected between two or more pedicle screws to create a pedicle screw construct. Indications for Use: The Fortex Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). | The material type on the label may incorrectly state Ti6Al-4V ELI. The rods are composed of Cobalt Chromium. | Class II | Terminated | |
| Z-0127-2017 | Calix T PEEK Lumbar System, TLIF Trial | 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. | Class II | Terminated | |
| Z-0126-2017 | Calix T PEEK Lumbar System, TLIF 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. | Class II | Terminated | |
| Z-0125-2017 | Calix P PEEK Lumbar System, PLIF Trial | 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. | Class II | Terminated | |
| Z-0124-2017 | 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. | Class II | Terminated | |
| Z-1823-2015 | Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400 | The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length. | Class II | Terminated | |
| Z-1512-2015 | 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. | Class II | Terminated | |
| Z-1396-2015 | 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 and maintain a port of entry for arthroscopic instruments or for an open procedure. The kit is also used to insert the OsteoSponge SC graft during surgery. Such procedures include, but are not limited to, subchondral bone repair. Affected Part numbers are 6508 and 6511. | 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. | Class II | Terminated | |
| Z-2136-2014 | 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 surgery. | Revision B of the tissue shields of the device was 7 mm longer than the previous design. | Class II | Terminated | |
| Z-1680-2014 | 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 or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. | 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 | Class II | Terminated | |
| Z-1138-2013 | OsteoSelect DBM Putty Product Usage: Orthopedic bone filler | The firm's retesting procedure was not validated. | Class II | Terminated | |
| Z-0936-2013 | 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. | Class II | Terminated | |
| Z-0800-2013 | 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 filler for voids or gaps in bone. Indicated for treatment of surgically created osseous defects. On 07/12/2012 an additional expired product was discovered by a Bacterin sales rep. B100078-908 with expiration date 04/27/2012 | Expired product was shipped to two customers. | Class II | Terminated | |
| Z-0034-2012 | Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set screw into the locking plate. | 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. | Terminated | ||
| Z-1694-2009 | 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 the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft. | 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 tolerance (undersized). | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain