SPINEFRONTIER, Inc. dba LESspine Innovations
Burlington, MA, US
SPINEFRONTIER, INC. DBA LESspine Innovations appears in FDA device records in Burlington, MA. FDA records list 24 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 33 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to SPINEFRONTIER, Inc. dba LESspine Innovations 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.
- Spinefrontier, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 24 510(k) clearances for SPINEFRONTIER, Inc. dba LESspine Innovations between 2007 and 2020. The busiest year on record is 2014, with 5. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2008 | 2 |
| 2009 | 2 |
| 2010 | 3 |
| 2011 | 1 |
| 2012 | 2 |
| 2013 | 2 |
| 2014 | 5 |
| 2015 | 4 |
| 2018 | 1 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K193106 | SpineFrontier Lumbar Interbody Fusion Device System | MAX | Substantially Equivalent | |
| K172484 | A-CIFT SoloFuse | OVE | Substantially Equivalent | |
| K151198 | A-CIFT SoloFuse | OVE | Substantially Equivalent | |
| K142504 | SpineFrontier Lumbar Interbody Fusion Device System | MAX | Substantially Equivalent | |
| K150017 | SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System | OUR | Substantially Equivalent | |
| K143377 | PedFuse Pedicle Screw System | MNH | Substantially Equivalent | |
| K141333 | ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE | ODP | Substantially Equivalent | |
| K142026 | SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE | ODP | Substantially Equivalent | |
| K141337 | ARENA-C | ODP | Substantially Equivalent | |
| K133153 | SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM | MNH | Substantially Equivalent | |
| K131880 | SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEM | OVE | Substantially Equivalent | |
| K132740 | SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM | NQW | Substantially Equivalent | |
| K123164 | SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM | MNH | Substantially Equivalent | |
| K121060 | SPINE FRONTIER INDUS ACP SYSTEM | KWQ | Substantially Equivalent | |
| K113518 | ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM | ODP | Substantially Equivalent | |
| K111553 | SPINEFRONTIER LUMBAR IBF SYSTEM | MAX | Substantially Equivalent | |
| K102020 | VEGA SPAN SPINOUS PROCESS PLATE SYSTEM | KWP | Substantially Equivalent | |
| K092815 | S-LIF INTERVERTEBRAL BODY FUSION DEVICE | MAX | Substantially Equivalent | |
| K093776 | INDUS ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K092420 | KRD1 PEDICLE SCREW SYSTEM | MNI | Substantially Equivalent | |
| K091638 | DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM2031 | MAX | Substantially Equivalent | |
| K073232 | INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX | KWQ | Substantially Equivalent | |
| K071420 | CHAMELEON FIXATION SYSTEM | MRW | Substantially Equivalent | |
| K072289 | SPINEFRONTIER DORADO VBR | MAX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005977257 | 3005977257 | SPINEFRONTIER, INC. DBA LESspine Innovations | 200 Summit Drive, Burlington, MA 01803 US | 2026 | and 3 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
- HRXArthroscope
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- LXHOrthopedic Manual Surgical Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- NQWOrthosis, Spine, Plate, Laminoplasty, Metal
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- HAERongeur, Manual
- OURSacroiliac Joint Fixation
- HWCScrew, Fixation, Bone
- PEKSpinous Process Plate
- MRWSystem, Facet Screw Spinal Device
Recall records
Showing 25 of 33| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1973-2019 | A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106) | There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw. | Class II | Terminated | |
| Z-1479-2015 | SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a manual surgical instrument that may be used as part of the PedFuse Pedicle Screw System and its MISquito components during percutaneous, minimally invasive surgical (MIS) technique of posterior pedicle screw fixation. | The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used incorrectly as the Surgical Technique does not adequately convey the intended use of the design. | Class II | Terminated | |
| Z-0977-2015 | lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164 | A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument. | Class II | Terminated | |
| Z-0555-2014 | PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system. | Screw inserters may not mate properly with hex interface of the screws. | Class II | Terminated | |
| Z-0554-2014 | PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system. | Screw inserters may not mate properly with hex interface of the screws. | Class II | Terminated | |
| Z-0576-2014 | Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position. | Mismarked and unmarked screws | Class II | Terminated | |
| Z-0575-2014 | Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the Invue Anterior Cervical Plate in position. | Mismarked and unmarked screws | Class II | Terminated | |
| Z-0574-2014 | Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position. | Mismarked and unmarked screws | Class II | Terminated | |
| Z-0573-2014 | Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure the Invue Anterior Cervical Plate in position. | Mismarked and unmarked screws | Class II | Terminated | |
| Z-0553-2014 | PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system. | Screw inserters may not mate properly with hex interface of the screws. | Class II | Terminated | |
| Z-0544-2014 | PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. | During routine servicing, it was discovered that one 8mmx55mm Reset screw was assembled with an 8mm tulip head and a 9mm screw. The implant should have consisted of an 8mm tulip head and an 8mm screw. A recall was initiated to remove all remaining screws of the same lot from the field to investigate the nonconformity. | Class II | Terminated | |
| Z-0778-2014 | Arena-L 38x28Trial Head I 10 Lordotic; Part: 11-81012-08, 11-81012-10, 11-81012-12, 11-81012-14 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties, each with multiple height configurations. The Trial Heads are intended to attach tot he Trial Handle (11-81002) and to be inserted into the intervertebral disc space. The Trial Handle consists of a knurled handle and cylindrical shaft with an M4 threads interface at the distal end; 17-4 Stainless steel is used as the material for the handles. The Trial Heads distract the disc space to the surgeon's desired height to gauge which size implant should be utilized to complete the Anterior Lumbar Interbody Fusion Procedure | Handles and heads may not be compatible. | Class II | Terminated | |
| Z-0777-2014 | Arena-L 35x26 Trial Head I 10 Lordotic; Part: 11-81004-08, 11-81004-10, 11-81004-12, 11-81004-14, 11-81004-16 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties, each with multiple height configurations. The Trial Heads are intended to attach tot he Trial Handle (11-81002) and to be inserted into the intervertebral disc space. The Trial Handle consists of a knurled handle and cylindrical shaft with an M4 threads interface at the distal end; 17-4 Stainless steel is used as the material for the handles. The Trial Heads distract the disc space to the surgeon's desired height to gauge which size implant should be utilized to complete the Anterior Lumbar Interbody Fusion Procedure. | Handles and heads may not be compatible. | Class II | Terminated | |
| Z-0776-2014 | Arena-L Trial Handle; Part: 11-81002 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties, each with multiple height configurations. The Trial Heads are intended to attach tot he Trial Handle (11-81002) and to be inserted into the intervertebral disc space. The Trial Handle consists of a knurled handle and cylindrical shaft with an M4 threads interface at the distal end; 17-4 Stainless steel is used as the material for the handles. The Trial Heads distract the disc space to the surgeon's desired height to gauge which size implant should be utilized to complete the Anterior Lumbar Interbody Fusion Procedure. | Handles and heads may not be compatible. | Class II | Terminated | |
| Z-0624-2014 | 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. | Class II | Terminated | |
| Z-0274-2014 | S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusions used for ratcheting. They come in straight and pointed varieties, either with or without a tab containing an additional bend. Extension shims are designed to slide down retractor blades, and are optional retractor components utilized during lumbar interbody fusion procedures. They are intended to manipulate tissue and prevent tissue from interfering inside the surgical field. | Fit variation among all lots of S-LIFT extension shims with corresponding retractor blades. The firm's investigation revealed that extension shims may not fit down all retractor blades. | Class II | Terminated | |
| Z-1933-2013 | Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of plates and screws used during fixation of anterior cervical plates to provide stabilization during the development of spine fusions. There is an array of 108 holes that store 3 types of screws. O4.2mm Self-Drilling, O4.2mm Self-Tapping, and O4.5mm Self-Tapping screws which are separated by type and screw length. The caddy has features to hold the screws in place. Recall expanded on 8/21/2013 to include additional lots of this product. | Difficulty removing screws from the Invue caddies. | Class II | Terminated | |
| Z-1665-2013 | S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an optional instrument to add further compression of the Inserter into the Implant during implantation of S-LIF Intervertebral Body Fusion Devices using bone graft to facilitate fusion of the spine of skeletally mature patients. Model: SI50003 RevA | The outer sleeve would not fit over the S-LIFT Inserter assembly because the hole at the top of the sleeve handle was too small. | Class II | Terminated | |
| Z-1664-2013 | BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all instrumentation to be used with a surgical system. Case and caddy components are used to contain implants intended for intervertebral body fusion and fixation of the spine. | The S-LIFT Instrument Case contained a bracket with peeling nylon coating. | Class II | Terminated | |
| Z-1927-2013 | Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm split, which allows the driver to collapse to fit into a screw and expand to retain the screw. | Device design. | Class II | Terminated | |
| Z-1666-2013 | InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are stainless steel instruments that have an inner shaft. The left and right inserters are used in combination with each other to place the implants into the body. Inserters are used to install the InSpan Spinous Plate System for the purpose of achieving supplemental fixation. | Potential for set screw to be come deformed. | Class II | Terminated | |
| Z-1870-2013 | S-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are used primarily to remove trial instruments that are used to estimate sizes of intervertebral body fusion devices intended to promote fusion. These devices were used in conjunction with lumbar intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients. | Malfunction of slap hammer. | Class II | Terminated | |
| Z-1958-2013 | Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan Lid: 12-60039A, 11-60042B, 11-60043B, 11-60045B, 11-60046C, 11-60045A, 11-60046A, 11-60053A; Invue Lid: SI70095A; S-Lift Lid: SI50070A; S-Lift Base: SI50067A; Arena-C Lid: 11-72013D, 11-72014D; Generics Lid: 12-99005A. System cases are designed to hold and secure all instrumentation to be used with a surgical system. | Non-toxic inks, used on the silk screen graphics of the case bases and lids, and caddy lids, were found to be either delaminating or running off from the substrate after repeated washing and sterilization cycles. | Class II | Terminated | |
| Z-1926-2013 | Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture, hold and drive pedicle screw assemblies. There is a capturing feature that engages and holds the screw in place. There is also a feature used to lock the screw to the inserter before insertion of the screw. They can also be used to remove screws or back screws out. Screw inserters are used during the implantation of spinal pedicle screws intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. Used in conjunction with Pedicle Screw Spinal system marketed as KRD1 PedFuse Pedicle Screw System . | Inserters have a set screw that fixes a collar to the inserter. The screw set can loosen and fall out of the inserter which allows the collar to slide off the proximal end of the inserter. When the collar is not in place the locking sleeve can also slide off the inserter. | Class II | Terminated | |
| Z-1871-2013 | Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Drill Guides were designed to provide a concentric pathway for the drills and taps to access the bone while protecting the soft tissue from the cutting geometry of the drills/taps. In addition the drill guide is used as a reference to measure depth that the drills and taps are protruding into bone, which is measured by depth markings at the proximal end of the drills/taps relative to the proximal end of the drill guide. These devices were used during implantation of spinal intervertebral body fusion devices intended for intervertebral body fusion of the spine of skeletally mature patients. | Prior to use in surgery, the Drill Guides were presenting noticeable degrees of denting and/or bending. As a result, drills and taps could not be directed down guides during surgery due to mechanical interference. | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets SPINEFRONTIER, Inc. dba LESspine Innovations edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain