Data / Medical devices / United States / SPINEFRONTIER, INC. DBA LESspine Innovations
SPINEFRONTIER, INC. DBA LESspine Innovations: FDA-registered device maker in Burlington, MA, United States, 7 510(k) clearances
SPINEFRONTIER, INC. DBA LESspine Innovations is registered with the FDA (registration 3005977257) in Burlington, MA, United States. It lists 13 device types. The FDA files 7 510(k) clearances under its listings, the newest dated August 27, 2025. 26 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005977257
- Address
- 200 Summit Drive Suite 505, Burlington, MA, United States, 01803
- Owner or operator
- LESspine Innovations (9094359)
- Roles
- Manufacturer, Specification developer
- First device listed
- August 18, 2008
- Registered through
- 2026
- Brand names listed
- A-CIFT SoloFuse, Arena-C, Arena-C HA, Arena-L, Dorado, E-LIFT, ELID, Endoscopic Less Invasive Decompression and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Manufacturer | accessdata.fda.gov |
| Arthroscope | HRX | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | 2 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Spinal Pedicle Fixation | MNI | 2 | Manufacturer | accessdata.fda.gov |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | 2 | Manufacturer | accessdata.fda.gov |
| Rongeur, Manual | HAE | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Sacroiliac Joint Fixation | OUR | 2 | Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Manufacturer | accessdata.fda.gov |
| Spinous Process Plate | PEK | 2 | Manufacturer | accessdata.fda.gov |
| System, Facet Screw Spinal Device | MRW | U | Manufacturer | 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 27, 2025 | K243774 | ELID (Endoscopic Less Invasive Decompression) System | HRX | Substantially Equivalent | Lesspine Innovations | accessdata.fda.gov |
| September 28, 2023 | K232605 | Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System | OUR | Substantially Equivalent | Lesspine Innovations | accessdata.fda.gov |
| June 19, 2020 | K193106 | SpineFrontier Lumbar Interbody Fusion Device System | MAX | Substantially Equivalent | Spinefrontier, Inc. | accessdata.fda.gov |
| May 8, 2018 | K172484 | A-CIFT SoloFuse | OVE | Substantially Equivalent | Spinefrontier, Inc. | accessdata.fda.gov |
| February 12, 2015 | K143377 | PedFuse Pedicle Screw System | MNH | Substantially Equivalent | Spinefrontier, Inc. | accessdata.fda.gov |
| October 20, 2014 | K142026 | SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE | ODP | Substantially Equivalent | Spinefrontier, Inc. | accessdata.fda.gov |
| September 8, 2014 | K141337 | ARENA-C | ODP | Substantially Equivalent | Spinefrontier, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 13, 2019 | 83166 | Class II | Terminated | 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. | accessdata.fda.gov |
| March 5, 2015 | 70488 | Class II | Terminated | 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 MIS | 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. | accessdata.fda.gov |
| December 19, 2014 | 70065 | Class II | Terminated | 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. | accessdata.fda.gov |
| November 20, 2013 | 66914 | Class II | Terminated | Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure the Invue Anterior Cervical Plate in position. | Mismarked and unmarked screws | accessdata.fda.gov |
| November 20, 2013 | 66873 | Class II | Terminated | 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, | Screw inserters may not mate properly with hex interface of the screws. | accessdata.fda.gov |
| October 18, 2013 | 66698 | Class II | Terminated | 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, an | 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. | accessdata.fda.gov |
| September 24, 2013 | 66298 | Class II | Terminated | 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 | Handles and heads may not be compatible. | accessdata.fda.gov |
| September 11, 2013 | 66273 | Class II | Terminated | 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. | accessdata.fda.gov |
| August 28, 2013 | 65760 | Class II | Terminated | 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 | 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. | accessdata.fda.gov |
| June 21, 2013 | 65653 | Class II | Terminated | 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 stabilizati | Difficulty removing screws from the Invue caddies. | accessdata.fda.gov |
| May 24, 2013 | 65429 | Class II | Terminated | 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 | 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. | accessdata.fda.gov |
| May 17, 2013 | 65432 | Class II | Terminated | 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 interver | The S-LIFT Instrument Case contained a bracket with peeling nylon coating. | accessdata.fda.gov |
| May 10, 2013 | 65444 | Class II | Terminated | 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 Ra | Device design. | accessdata.fda.gov |
| May 7, 2013 | 65442 | Class II | Terminated | 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 p | Potential for set screw to be come deformed. | accessdata.fda.gov |
| April 25, 2013 | 65033 | Class II | Terminated | 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. Thes | Malfunction of slap hammer. | accessdata.fda.gov |
| April 22, 2013 | 64970 | Class II | Terminated | 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 | 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. | accessdata.fda.gov |
| March 14, 2013 | 64984 | Class II | Terminated | 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. T | 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. | accessdata.fda.gov |
| November 9, 2012 | 64985 | Class II | Terminated | 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 f | 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. | accessdata.fda.gov |
| October 5, 2012 | 64987 | Class II | Terminated | Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized fashion within the case, 8mm and 9mm pedicle screws used during implantation of pedicle screw system devices intend | Two sections that are designated for the 8mm and 9mm screws were switched; the holes that hold the 8mm screws are designed for 9mm screws, and the holes that hold the 9mm screws are designated for 8mm screws. | accessdata.fda.gov |
| August 29, 2012 | 64993 | Class II | Terminated | T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled instruments that have a quick release end. The silicone T-handle has an impactor cap on the proximal end of the handle wh | During an operation the strike plate of a T-Handle loosened and separated from the T-Handle. | accessdata.fda.gov |
| August 28, 2012 | 63144 | Class II | Terminated | Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compressors provide pressure to drive spikes of Inspan implants into the spinous process bone, resulting in fixation of the implant. | Inspan Compressors may break at weld causing a loss of compression | accessdata.fda.gov |
| August 22, 2012 | 63075 | Class II | Terminated | S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223 Product Usage: Surgical Guides allow a surgeon to place implants into tight spaces, such as a vertebral disc space, without having the implant | When using the optional S-LIFT (also known as S-LIF) Implant Guides without stops, there is a known risk of moving the Implant Guides, and possibly the implant, too far into the disc space creating the potential for injury to the patient. The instructions for Use for the S-Lift Implant Guides will be amended to add the following warning: "Care is to be taken | accessdata.fda.gov |
| May 9, 2012 | 64994 | Class II | Terminated | Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the screw when changing axis of insertion during fixation of spinal intervertebral. | The nipple of the tipped driver broke off when surgeons were attempting to insert the screw. | accessdata.fda.gov |
| December 30, 2011 | 64989 | Class II | Terminated | KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as a linking mechanism between pedicle screws. The rod sits with the pedicle screw tulip and they are locked into plac | One of the rods in each of two test constructs did not meet fatigue requirement as outlined in ASTM F1717-04 dynamic compression testing 5 million cycles. | accessdata.fda.gov |
| December 23, 2011 | 63145 | Class II | Terminated | SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery. Product Usage: The S-Lift Lock Shaft SI50001 mates with SI50002, Implant Inserter, to a | It has been verified through field use that there are two possible breakages that may occur when using SI50001 Revision D Lock Shaft Inserter, possibly resulting in instrument fragments entering the sterile field: Impact Cap: The impact cap on the Lock Shaft Inserter can shear off under high-impact force during insertion and removal. Pin: The pin used to gui | accessdata.fda.gov |
| May 10, 2008 | 64991 | Class II | Terminated | Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc space during implantation of intervertebral body fusion devices. | During two separate occasions an impactor plate on the handle broke off while being struck by a mallet. | accessdata.fda.gov |
Compare with other makers
- All makers of Intervertebral Fusion Device With Integrated Fixation, Cervical
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Orthosis, Spinal Pedicle Fixation
- All makers of Orthosis, Spondylolisthesis Spinal Fixation
Updated August 27, 2025. 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.