SpineFrontier, Inc.
FDA Regulatory Profile
SpineFrontier, Inc. has 33 FDA recalls, 6 inspections, 24 510(k) clearances and 1 compliance action on record.
What these totals cover: FDA records filed under the name "SpineFrontier, Inc." and its spelling variant "Spinefrontier".
On this page: Recalls (33) · Inspections (6) · Compliance actions (1) · Facilities (1) · 510(k) clearances (24)
Latest recall Z-1973-2019 · Class II · Jun 13, 2019Latest inspection Apr 2, 2026 · NAI
Latest 510(k) Jun 19, 2020
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Summary
Record counts and when each FDA source was last refreshed
Records Count Last refreshed Source as of Status
Recalls 33 Nov 8, 2026 File dated Nov 3, 2026 Current 510(k) clearances 24 Nov 8, 2026 File dated Nov 2, 2026 Current Inspections 6 Nov 14, 2026 Newest record Nov 5, 2026 Current Compliance actions 1 Nov 2, 2026 Newest record Oct 29, 2026 Current
FDA record by year
SpineFrontier, Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).
SpineFrontier, Inc.: FDA inspections per year
2017: 1 inspections 1 2017 2018: 0 inspections 0 2018 2019: 1 inspections 1 2019 2020: 0 inspections 0 2020 2021: 0 inspections 0 2021 2022: 0 inspections 0 2022 2023: 0 inspections 0 2023 2024: 0 inspections 0 2024 2025: 0 inspections 0 2025 2026: 1 inspections 1 2026
Year Inspections OAI Warning letters Recall records Class I
2026 1 0 0 0 0 2025 0 0 0 0 0 2024 0 0 0 0 0 2023 0 0 0 0 0 2022 0 0 0 0 0 2021 0 0 0 0 0 2020 0 0 0 0 0 2019 1 0 0 1 0 2018 0 0 0 0 0 2017 1 0 0 0 0
Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.
33 recall records from May 10, 2008 to Jun 13, 2019. Showing the 20 most recent. View all 33 recall records
Number Class Product Date
Z-1973-2019 Class II A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and… Jun 13, 2019 Z-1479-2015 Class II SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number… Mar 5, 2015 Z-0977-2015 Class II lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164 Dec 19, 2014 Z-0553-2014 Class II PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The PedFuse Screw… Nov 20, 2013 Z-0576-2014 Class II Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure the Invue Anterior… Nov 20, 2013 Z-0574-2014 Class II Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to secure the Invue… Nov 20, 2013 Z-0573-2014 Class II Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure the Invue Anterior… Nov 20, 2013 Z-0554-2014 Class II PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111 The PedFuse… Nov 20, 2013 Z-0575-2014 Class II Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the Invue Anterior Cervical… Nov 20, 2013 Z-0555-2014 Class II PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113 The PedFuse Screw… Nov 20, 2013 Z-0544-2014 Class II PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be… Oct 18, 2013 Z-0777-2014 Class II Arena-L 35x26 Trial Head I 10¿ Lordotic; Part: 11-81004-08, 11-81004-10, 11-81004-12, 11-81004-14… Sep 24, 2013 Z-0778-2014 Class II Arena-L 38x28Trial Head I 10¿ Lordotic; Part: 11-81012-08, 11-81012-10, 11-81012-12, 11-81012-14… Sep 24, 2013 Z-0776-2014 Class II Arena-L Trial Handle; Part: 11-81002 The trial heads are smooth plates that mimic the footprint… Sep 24, 2013 Z-0624-2014 Class II PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation. Sep 11, 2013 Z-0274-2014 Class II S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved… Aug 28, 2013 Z-1933-2013 Class II Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case… Jun 21, 2013 Z-1665-2013 Class II S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an optional instrument to… May 24, 2013 Z-1664-2013 Class II BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all… May 17, 2013 Z-1927-2013 Class II Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue… May 10, 2013
6 inspections from Jul 11, 2012 to Apr 2, 2026.
Date Site Product Classification FEI
Apr 2, 2026 Burlington, MA Devices No Action Indicated (NAI) 3005977257 Jan 29, 2019 Burlington, MA Devices Voluntary Action Indicated (VAI) 3005977257 Nov 29, 2017 Burlington, MA Biologics No Action Indicated (NAI) 3005977257 Feb 10, 2016 Burlington, MA Biologics No Action Indicated (NAI) 3005977257 Aug 5, 2013 Burlington, MA Devices No Action Indicated (NAI) 3005977257 Jul 11, 2012 Burlington, MA Devices Official Action Indicated (OAI) 3005977257
NAI No objectionable conditions or practices were found during the inspection.
VAI Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI Regulatory and/or administrative actions are recommended.
Look up the inspector observations behind these results with the FDA 483 search , or check for formal enforcement with the FDA warning letter search .
1 inspected site, newest inspection first.
Facility Location Inspections Latest
FEI 3005977257 Burlington, MA 6 Apr 2, 2026
24 510(k) clearances from Nov 1, 2007 to Jun 19, 2020. Showing the 20 most recent. View all 24 510(k) clearances
K-Number Device Date
K193106 SpineFrontier Lumbar Interbody Fusion Device System Jun 19, 2020 K172484 A-CIFT SoloFuse May 8, 2018 K151198 A-CIFT SoloFuse Jul 17, 2015 K142504 SpineFrontier Lumbar Interbody Fusion Device System May 13, 2015 K150017 SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System Apr 24, 2015 K143377 PedFuse Pedicle Screw System Feb 12, 2015 K141333 ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE Nov 25, 2014 K142026 SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE Oct 20, 2014 K141337 ARENA-C Sep 8, 2014 K133153 SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM May 14, 2014 K131880 SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEM Jan 3, 2014 K132740 SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM Nov 26, 2013 K123164 SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM Feb 15, 2013 K121060 SPINE FRONTIER INDUS ACP SYSTEM Jul 3, 2012 K113518 ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM Feb 16, 2012 K111553 SPINEFRONTIER LUMBAR IBF SYSTEM Sep 28, 2011 K102020 VEGA SPAN SPINOUS PROCESS PLATE SYSTEM Sep 1, 2010 K092815 S-LIF INTERVERTEBRAL BODY FUSION DEVICE Jun 30, 2010 K093776 INDUS ANTERIOR CERVICAL PLATE SYSTEM Mar 26, 2010 K092420 KRD1 PEDICLE SCREW SYSTEM Nov 19, 2009
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