SpineFrontier, Inc.
Medical device manufacturer in Malden, MA.
24510(k) clearances
0PMA approvals
33recalls
Device types
- MAX Intervertebral Fusion Device With Bone… 6
- ODP Intervertebral Fusion Device With Bone… 4
- KWQ Appliance, Fixation, Spinal Intervertebral… 3
- MNH Orthosis, Spondylolisthesis Spinal Fixation 3
- OVE Intervertebral Fusion Device With… 3
- MRW System, Facet Screw Spinal Device 1
- MNI Orthosis, Spinal Pedicle Fixation 1
- KWP Appliance, Fixation, Spinal Interlaminal 1
- NQW Orthosis, Spine, Plate, Laminoplasty, Metal 1
- OUR Sacroiliac Joint Fixation 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K193106 | SpineFrontier Lumbar Interbody Fusion Device SystemMAX · Special | 06/19/2020SE |
| K172484 | A-CIFT SoloFuseOVE · Traditional | 05/08/2018SE |
| K151198 | A-CIFT SoloFuseOVE · Special | 07/17/2015SE |
| K142504 | SpineFrontier Lumbar Interbody Fusion Device SystemMAX · Traditional | 05/13/2015SE |
| K150017 | SpineFrontier SIJFuse Sacroiliac Joint Fusion Device SystemOUR · Traditional | 04/24/2015SE |
| K143377 | PedFuse Pedicle Screw SystemMNH · Special | 02/12/2015SE |
| K141333 | Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceODP · Traditional | 11/25/2014SE |
| K142026 | Spinefrontier Arena-C Ha PEEK Cervical Intervertebral Body Fusion DeviceODP · Traditional | 10/20/2014SE |
| K141337 | Arena-CODP · Traditional | 09/08/2014SE |
| K133153 | Spinefrontier Pedfuse Pedicle Screw SystemMNH · Special | 05/14/2014SE |
| K131880 | Spinefrontier A-Cift Solofuse Cervical Intervertebral Fusion Device SystemOVE · Abbreviated | 01/03/2014SE |
| K132740 | Spinefrontier Lesplasty Posterior Cervical Laminoplasty SystemNQW · Traditional | 11/26/2013SE |
| K123164 | Spinefrontier Pedfuse Pedicle Screw SystemMNH · Traditional | 02/15/2013SE |
| K121060 | Spine Frontier Indus Acp SystemKWQ · Special | 07/03/2012SE |
| K113518 | Arena-C Cervical Intervertebral Body Fusion SystemODP · Abbreviated | 02/16/2012SE |
| K111553 | Spinefrontier Lumbar Ibf SystemMAX · Abbreviated | 09/28/2011SE |
| K102020 | Vega Span Spinous Process Plate SystemKWP · Traditional | 09/01/2010SE |
| K092815 | S-Lif Intervertebral Body Fusion DeviceMAX · Abbreviated | 06/30/2010SE |
| K093776 | Indus Anterior Cervical Plate SystemKWQ · Traditional | 03/26/2010SE |
| K092420 | KRD1 Pedicle Screw SystemMNI · Traditional | 11/19/2009SE |
| K091638 | Dorado Wide Intervertebral Body Cage, Models: IM2010-IM2031MAX · Abbreviated | 09/14/2009SE |
| K073232 | Indus Anterior Cervical Plate System, Model IM3XXXKWQ · Traditional | 02/20/2008SE |
| K071420 | Chameleon Fixation SystemMRW · Traditional | 01/16/2008SE |
| K072289 | Spinefrontier Dorado VBRMAX · Traditional | 11/01/2007SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1973-2019 Class II | A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers…There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation… | 06/13/2019Terminated |
| Z-1479-2015 Class II | SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part…The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used… | 03/05/2015Terminated |
| Z-0977-2015 Class II | lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use… | 12/19/2014Terminated |
| Z-0576-2014 Class II | Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure the Invue…Mismarked and unmarked screws | 11/20/2013Terminated |
| Z-0575-2014 Class II | Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the Invue Anterior…Mismarked and unmarked screws | 11/20/2013Terminated |
| Z-0574-2014 Class II | Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to secure the…Mismarked and unmarked screws | 11/20/2013Terminated |
| Z-0573-2014 Class II | Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure the Invue…Mismarked and unmarked screws | 11/20/2013Terminated |
| Z-0555-2014 Class II | PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113 The…Screw inserters may not mate properly with hex interface of the screws. | 11/20/2013Terminated |
| Z-0554-2014 Class II | PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111 The…Screw inserters may not mate properly with hex interface of the screws. | 11/20/2013Terminated |
| Z-0553-2014 Class II | PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The…Screw inserters may not mate properly with hex interface of the screws. | 11/20/2013Terminated |
| Z-0544-2014 Class II | PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants…During routine servicing, it was discovered that one 8mmx55mm Reset screw was assembled with an 8mm tulip… | 10/18/2013Terminated |
| Z-0778-2014 Class II | Arena-L 38x28Trial Head I 10 Lordotic; Part: 11-81012-08, 11-81012-10, 11-81012-12…Handles and heads may not be compatible. | 09/24/2013Terminated |
| Z-0777-2014 Class II | Arena-L 35x26 Trial Head I 10 Lordotic; Part: 11-81004-08, 11-81004-10, 11-81004-12…Handles and heads may not be compatible. | 09/24/2013Terminated |
| Z-0776-2014 Class II | Arena-L Trial Handle; Part: 11-81002 The trial heads are smooth plates that mimic the…Handles and heads may not be compatible. | 09/24/2013Terminated |
| Z-0624-2014 Class II | PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications. | 09/11/2013Terminated |
| Z-0274-2014 Class II | S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are…Fit variation among all lots of S-LIFT extension shims with corresponding retractor blades. The firm's… | 08/28/2013Terminated |
| Z-1933-2013 Class II | Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within…Difficulty removing screws from the Invue caddies. | 06/21/2013Terminated |
| Z-1665-2013 Class II | S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an optional…The outer sleeve would not fit over the S-LIFT Inserter assembly because the hole at the top of the sleeve… | 05/24/2013Terminated |
| Z-1664-2013 Class II | BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure…The S-LIFT Instrument Case contained a bracket with peeling nylon coating. | 05/17/2013Terminated |
| Z-1927-2013 Class II | Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with…Device design. | 05/10/2013Terminated |
| Z-1666-2013 Class II | InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters…Potential for set screw to be come deformed. | 05/07/2013Terminated |
| Z-1870-2013 Class II | S-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are used…Malfunction of slap hammer. | 04/25/2013Terminated |
| Z-1958-2013 Class II | Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan Lid:…Non-toxic inks, used on the silk screen graphics of the case bases and lids, and caddy lids, were found to… | 04/22/2013Terminated |
| Z-1926-2013 Class II | Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are…Inserters have a set screw that fixes a collar to the inserter. The screw set can loosen and fall out of the… | 03/14/2013Terminated |
| Z-1871-2013 Class II | Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse…Prior to use in surgery, the Drill Guides were presenting noticeable degrees of denting and/or bending. As a… | 11/09/2012Terminated |
| Z-1869-2013 Class II | Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds…Two sections that are designated for the 8mm and 9mm screws were switched; the holes that hold the 8mm… | 10/05/2012Terminated |
| Z-1932-2013 Class II | T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are…During an operation the strike plate of a T-Handle loosened and separated from the T-Handle. | 08/29/2012Terminated |
| Z-0412-2013 Class II | Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compressors provide…Inspan Compressors may break at weld causing a loss of compression | 08/28/2012Terminated |
| Z-0417-2013 Class II | S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223 Product…When using the optional S-LIFT (also known as S-LIF) Implant Guides without stops, there is a known risk of… | 08/22/2012Terminated |
| Z-1957-2013 Class II | Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the…The nipple of the tipped driver broke off when surgeons were attempting to insert the screw. | 05/09/2012Terminated |
| Z-1737-2013 Class II | KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical…One of the rods in each of two test constructs did not meet fatigue requirement as outlined in ASTM F1717-04… | 12/30/2011Terminated |
| Z-1565-2014 Class II | SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral…It has been verified through field use that there are two possible breakages that may occur when using… | 12/23/2011Terminated |
| Z-1482-2013 Class II | Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position…During two separate occasions an impactor plate on the handle broke off while being struck by a mallet. | 05/10/2008Terminated |