Titan Spine, LLC
Mequon, WI, US
Titan Spine, LLC appears in FDA device records in Mequon, WI. FDA records list 19 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 19 510(k) clearances for Titan Spine, LLC between 2008 and 2020. The busiest year on record is 2019, with 4. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 2 |
| 2011 | 1 |
| 2014 | 3 |
| 2015 | 3 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 4 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device | OVD | Substantially Equivalent | |
| K192054 | Endoskeleton TAS Plate | OVD | Substantially Equivalent | |
| K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device | ODP | Substantially Equivalent | |
| K191565 | Endoskeleton TCS Interbody Fusion Device | OVE | Substantially Equivalent | |
| K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device | ODP | Substantially Equivalent | |
| K173535 | Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device | ODP | Substantially Equivalent | |
| K170399 | Endoskeleton TO Interbody Fusion Device (IBD) | MAX | Substantially Equivalent | |
| K163269 | Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device | OVD | Substantially Equivalent | |
| K153122 | Endoskeleton(r) TCS System | OVE | Substantially Equivalent | |
| K151596 | Endoskeleton TCS Interbody Fusion Device | OVE | Substantially Equivalent | |
| K142940 | Endoskeleton TCS System | OVE | Substantially Equivalent | |
| K141953 | ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL | MAX | Substantially Equivalent | |
| K142589 | Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL | MAX | Substantially Equivalent | |
| K140055 | ENDOSKELETON(R) TL INTERBODY FUSION DEVICE | MAX | Substantially Equivalent | |
| K111626 | ENDOSKELETON(R) TAS | OVD | Substantially Equivalent | |
| K102067 | ENDOSKELETON TO | MAX | Substantially Equivalent | |
| K100889 | ENDOSKELETON TC | ODP | Substantially Equivalent | |
| K083714 | ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD) | MAX | Substantially Equivalent | |
| K080615 | ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD) | MAX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2327-2015 | Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spinal implant. Part Numbers / Product Description: 5302-3514 / 03.5 x 14mm Locking Screws; 5302-3516 / 03.5 x 16mm Locking Screws; 502-3518 / 03.5 x 18mm Locking Screws; 5302-3814 / 03.8 x 14mm Locking Screws; 5302-3816 / 03.8 x 16 mm Locking Screws; 5302-3818 / 03.8 x 18mm Locking Screws. | Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'. | Class II | Terminated | |
| Z-1324-2015 | Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC. Endo TCS driver is one of the instruments within the surgical tray for use with the Interbody Fusion Device(IBD). | The TCS Straight Hexlobular #6 Drivers (5210-1004) tip sheared off during use in procedures that involved patients with dense bones. As a result of this malfunction, Titan Spine, LLC is removing all of the TCS Straight Hex lobular #6 Drivers (5210-1004) Lot# G150101 from the field. | Class II | Terminated | |
| Z-0535-2013 | Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm Standard Endoskeleton Implant VBR 2107-0218 18mm Large Endoskeleton Implant VBR 2107-0220 20mm Large Endoskeleton Implant VBR Endoskeleton TA VBR is intended for use in the thoracolumbar spine (T1-L5) to replace all or part of a collapsed, damaged, or unstable vertebral body due to tumor or trauma. | Titan Spine LLC, is conducting a recall on the Endoskeleton TA VBR products. The labeling accompanying this device contains incorrect indications for use. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain