Data / Medical devices / United States / Orthofix Us LLC
Orthofix Us LLC: FDA-registered device maker in Lewisville, TX, United States, 155 510(k) clearances and 4 PMA approvals
Orthofix Us LLC is registered with the FDA (registration 2183449) in Lewisville, TX, United States. It lists 95 device types. The FDA files 155 510(k) clearances and 4 PMA approvals under its listings, the newest dated October 31, 2025. 24 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2183449
- Address
- 3451 Plano Parkway, Lewisville, TX, United States, 75056
- Owner or operator
- Orthofix US LLC (10028162)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- January 5, 2009
- Registered through
- 2027
- Brand names listed
- 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallma, ASCENT POSTERIOR OCCIPITAL THORACIC (POCT) SYSTEM (TITANIUM & COBALT CHROME RODS), AZURE ANTERIOR CERVICAL PLATE SYSTEM, Accelstim, Agile Nail, Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Def, Atlas Spine Expandable Interbody System, Azure Anterior Cervical Plate System and more
Devices it lists
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. Newest 100 of 155.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 31, 2025 | K252088 | Firebird SI Navigation System | OLO | Substantially Equivalent | Orthofix US, LLC | accessdata.fda.gov |
| April 10, 2025 | K250112 | FitboneTM Trochanteric | HSB | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| December 3, 2024 | K242861 | TrueLok Elevate | KTT | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| June 21, 2024 | K241117 | M6-C Single Use, Disposable Instrumentation | QLQ | Substantially Equivalent | Spinal Kinetics / Orthofix / Seaspine | accessdata.fda.gov |
| June 18, 2024 | K233867 | Fitbone Trochanteric | HSB | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| May 28, 2024 | K240749 | PILLAR SA Ti Spacer System (82-XXX) | MAX | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| May 3, 2024 | K232648 | RODEO Telescopic Nail | HSB | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| March 22, 2024 | K232169 | FITBONE® Transport and Lengthening System | HSB | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| June 2, 2022 | K220861 | M6-C Artificial Cervical Disc Instruments AS | QLQ | Substantially Equivalent | Spinal Kinetics, LLC | accessdata.fda.gov |
| February 11, 2022 | K211712 | 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System | KWQ | Substantially Equivalent | Orthofix US, LLC | accessdata.fda.gov |
| January 18, 2022 | K213572 | JuniOrtho Plating System | HWC | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| January 5, 2022 | K213951 | FORZA XP Expandable Spacer System | MAX | Substantially Equivalent | Orthofix US, LLC | accessdata.fda.gov |
| November 5, 2021 | K212044 | TrueLok Evo | KTT | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| August 31, 2021 | K211704 | CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion System | ODP | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| July 30, 2021 | K211710 | Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System | NKG | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| April 20, 2021 | K210157 | SOLE Medial Column Fusion Plate | HRS | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| March 25, 2021 | K210667 | FIREBIRD SI Fusion System | OUR | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| March 18, 2021 | K203342 | CONSTRUX Mini Ti Spacer System | ODP | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| March 3, 2021 | K203576 | FORZA Ti Spacer System | MAX | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| February 17, 2021 | K203399 | FITBONE(R) TAA | HSB | Substantially Equivalent | Wittenstein Intens GmbH | accessdata.fda.gov |
| November 18, 2020 | K203138 | FIREBIRD SI Fusion System | OUR | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| October 29, 2020 | K202949 | CONSTRUX Mini PEEK Spacer System | ODP | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| October 14, 2020 | K202666 | CONSTRUX Mini PTC Spacer System | ODP | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| September 15, 2020 | K201664 | FIREBIRD SI Fusion System | OUR | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| June 15, 2020 | K201481 | Centurion POCT System | NKG | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| May 22, 2020 | K200246 | JPS JuniOrtho Plating System | HRS | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| May 1, 2020 | K200606 | O-Genesis Graft Delivery System | FMF | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| April 9, 2020 | K200052 | CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System | ODP | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| April 2, 2020 | K200696 | FIREBIRD SI Fusion System | OUR | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| June 7, 2019 | K190388 | RIVAL View Plating Systems and Reduce Fracture Plating Systems | HRS | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| May 22, 2019 | K190751 | Connector System | NKG | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| April 30, 2019 | K183342 | SambaScrew 3D SI Fusion System | OUR | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| August 24, 2018 | K180179 | Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Phoenix® Minimally Invasive Spinal Fixation System; Phoenix® CDX Minimally Invasive Spinal Fixation System; JANUS® Midline Fixation Screw; JANUS® Fenestrated Screw | NKB | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| May 15, 2018 | K180624 | Guided Growth Plate System Plus | OBT | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| April 23, 2018 | K172699 | Agile Nail | HSB | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| March 8, 2018 | K172115 | Navigated Instrument System | OLO | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| February 7, 2018 | K172698 | G-Beam Fusion Beaming System | HWC | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| January 22, 2018 | K180025 | Centurion POCT System | NKG | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| January 19, 2018 | K172696 | FORZA® XP Expandable Spacer System | MAX | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| January 9, 2018 | K172183 | Guided Growth Plate System Plus | OBT | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| November 16, 2017 | K173051 | Orthofix MJ-FLEX THE NEW METAIZEAU NAIL | HTY | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| November 2, 2017 | K172437 | CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System | ODP | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| October 12, 2017 | K170146 | Galaxy UNYCO System | KTT | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| August 18, 2017 | K172194 | Connector System | NKG | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| May 11, 2017 | K170647 | Connector System | NKG | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| May 10, 2017 | K170650 | Orthofix TrueLok Hexapod System (TL-HEX) V2.0 | KTT | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| May 5, 2017 | K171082 | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System | NKB | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| April 18, 2017 | K163523 | ECHELON CIRCULAR Powered Stapler | GDW | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| March 13, 2017 | K162921 | Navigated Instrument System | OLO | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| February 9, 2017 | K162918 | Atlas Spine Expandable Interbody System | MAX | Substantially Equivalent | Atlas Spine, Inc. | accessdata.fda.gov |
| January 26, 2017 | K163368 | FITBONE TAA | HSB | Substantially Equivalent | Wittenstein Intens GmbH | accessdata.fda.gov |
| January 24, 2017 | K161466 | ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System | HSB | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| January 3, 2017 | K163421 | syngo.via MI Workflows | LLZ | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| December 22, 2016 | K162446 | FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System | MAX | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| December 16, 2016 | K162638 | CETRA Anterior Cervical Plate System | KWQ | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| September 8, 2016 | K161129 | PILLAR SA PTC | OVD | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| June 17, 2016 | K161280 | Cervical Stand Alone System | OVE | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| January 29, 2016 | K153428 | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System | NKB | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| January 14, 2016 | K152475 | FORZA PTC Spacer System | MAX | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| January 6, 2016 | K153233 | Galaxy UNYCO System | KTT | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| September 11, 2015 | K150619 | CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System | ODP | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| July 7, 2015 | K151488 | Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System | NKB | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| May 29, 2015 | K143028 | Azure Anterior Cervical Plate System | KWQ | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| May 15, 2015 | K150822 | Centurion POCT System | NKG | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| January 8, 2015 | K142152 | CONSTRUX MINI PEEK; SPACER SYSTEM, TI SPACER SYSTEM, CERVICAL STAND ALONE SYSTEM | ODP | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| January 2, 2015 | K141186 | FIREBIRD SPINAL FIXATION SYSTEM | NKB | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| December 8, 2014 | K141760 | ORTHOFIX GALAXY WRIST | KTT | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| December 5, 2014 | K142052 | ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT | KTT | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| November 12, 2014 | K141571 | ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM | HSB | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| August 28, 2014 | K142135 | REDUCE FRACTURE PLATING SYSTEM LINE EXTENSION | HRS | Substantially Equivalent | Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic | accessdata.fda.gov |
| July 22, 2014 | K140876 | VIEW PLATING SYSTEM,REDUCE FRACTURE PLATING SYSTEM,BONE SCREW | HRS | Substantially Equivalent | Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic | accessdata.fda.gov |
| July 2, 2014 | K140260 | SKYHAWK LATERAL PLATE SYSTEM | KWQ | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| May 27, 2014 | K140709 | SKYHAWK INTERBODY FUSION SYSTEM | MAX | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| April 14, 2014 | K132999 | CERVICAL STAND ALONE SYSTEM | OVE | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| January 30, 2014 | K131833 | CENTURION POCT SYSTEM | KWP | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| November 20, 2013 | K132893 | EDGE ORTHOPAEDICS BITE COMPRESSION SCREW | HWC | Substantially Equivalent | Icon Orthopaedic Concepts Dba Edge Orthopaedics | accessdata.fda.gov |
| August 7, 2013 | K130932 | FIREBIRD SPINAL FIXATION SYSTEM | NKB | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| May 7, 2013 | K130825 | AZURE ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| March 28, 2013 | K130176 | FIREBIRD SPINAL FIXATION SYSTEM | NKB | Substantially Equivalent | Orthofix | accessdata.fda.gov |
| December 3, 2012 | K122901 | FIREBIRD SPINAL FIXATION SYSTEM, PHOENIX MIS SPINAL FIXATION SYSTEM | NKB | Substantially Equivalent | Orthofix | accessdata.fda.gov |
| November 29, 2012 | K121649 | CONSTRUX MINI PEEK TI SPACER SYSTEM | ODP | Substantially Equivalent | Orthofix | accessdata.fda.gov |
| September 20, 2012 | K122541 | ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) | KTW | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| September 4, 2012 | K113770 | ORTHOFIX GALAXY FIXATION SYSTEM | KTT | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| August 20, 2012 | K121148 | SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA SCREW 9MM DIA., 35MM LONG, SAMBA SCREW, 9MM D | HWC | Substantially Equivalent | Medical Design, LLC | accessdata.fda.gov |
| July 20, 2012 | K121658 | ORTHOFIX ACP (ANTERIOR CERVICAL PLATE SYSTEM) | KWQ | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| February 16, 2012 | K111448 | ICON (TM) MODULAR PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| June 21, 2011 | K110805 | GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL) | OBT | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| May 24, 2011 | K111183 | ASCENT POSTERIOR OCCIPITAL THORACIC (POCT) SYSTEM (TITANIUM & COBALT CHROME RODS) | KWP | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| March 23, 2011 | K103111 | FORZA SPACER SYSTEM | MAX | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| December 15, 2010 | K102201 | CONTOURS LAPIDUS PLATING SYSTEM | HRS | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| October 20, 2010 | K101936 | CONTOURS VSP III VOLAR PLATING SYSTEM | HRS | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| September 27, 2010 | K101812 | CONSTRUX MINI PEEK SPACER SYSTEM | ODP | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| July 28, 2010 | K093926 | FIREBIRD SPINAL FIXATION SYSTEM | NKB | Substantially Equivalent | Blackstone Medical, Inc. | accessdata.fda.gov |
| June 10, 2010 | K093442 | GUIDED GROWTH SYSTEM | OBT | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| May 4, 2010 | K100614 | HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES | KWQ | Substantially Equivalent | Blackstone Medical, Inc. | accessdata.fda.gov |
| February 19, 2010 | K093805 | OSCAR 3 | JDX | Substantially Equivalent | Orthosonics, Ltd. | accessdata.fda.gov |
| February 4, 2010 | K100044 | FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY | NKB | Substantially Equivalent | Blackstone | accessdata.fda.gov |
| September 25, 2009 | K092624 | FIREBIRD SPINAL FIXATION SYSTEM | NKB | Substantially Equivalent | Blackstone Medical, Inc. | accessdata.fda.gov |
| October 17, 2008 | K082797 | BLACKSTONE PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent | Blackstone Medical, Inc. | accessdata.fda.gov |
| September 15, 2008 | K081684 | BLACKSTONE PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent | Blackstone Medical, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| May 3, 2022 | P210035 | AccelStimTM Bone Growth Stimulator | LOF | 2 | March 21, 2025 | accessdata.fda.gov |
| February 6, 2019 | P170036 | M6-C Artificial Cervical Disc | MJO | 16 | August 19, 2024 | accessdata.fda.gov |
| December 23, 2004 | P030034 | CERVICAL-STIM MODEL 505L CERVICAL FUSION SYSTEM | LOF | 16 | June 14, 2022 | accessdata.fda.gov |
| February 21, 1986 | P850007 | PHYSIO-STIM(TM) I & II MODEL 6000 & 7000 | LOF | 43 | June 14, 2022 | 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 10, 2026 | 99225 | Class II | Ongoing | Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device | Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 | accessdata.fda.gov |
| November 3, 2025 | 97862 | Class III | Ongoing | Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/Catalog Number: 37-3106SP 12mm W X 12mm L, 6mm H, Parallel; 37-3107SP 12mm W X 12mm L, 7mm H, Parallel; 37-3108SP 12mm W X | Labeling contains claims that are not consistently present. | accessdata.fda.gov |
| September 19, 2025 | 97689 | Class II | Ongoing | Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected: 1. POLYAXIAL SCREW, CC, 5.5mm X 30mm; Item Number: TL1-10755030. 2. POLYAXIAL SCREW, CC, 5.5mm X 35mm; | Polyaxial screws do not meet performance standards. | accessdata.fda.gov |
| June 24, 2025 | 97265 | Class II | Ongoing | PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP | A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 mm width on the front labels is correct. | accessdata.fda.gov |
| February 20, 2025 | 96351 | Class II | Ongoing | Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: (1) REF 82-3300SP, 33mm W x 24mm D x 10mm H, 7 degrees; (2) REF 82-3700SP, 37mm W x 28mm D x 10mm H, 7 | The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm. | accessdata.fda.gov |
| April 6, 2018 | 79819 | Class II | Terminated | Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-011C | Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery. | accessdata.fda.gov |
| February 23, 2018 | 79498 | Class II | Terminated | ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003 | Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: 79-2003) with affected Lot Numbers 002, 003 and 004. Through the company's manufacturing controls, size discrepancies were noted with the drive feature for both the large and small sets screws. As a r | accessdata.fda.gov |
| August 2, 2017 | 77882 | Class II | Terminated | Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, Rx..A Decorticating Planer is used to decorticate bone surrounding the spherical head of an implanted bone screw in order to provid | The plastic core of the Decorticating Planer was found to be missing, which could result in scoring of the bone screw neck if used at or beyond a 23 degree angle. | accessdata.fda.gov |
| April 27, 2016 | 73978 | Class II | Terminated | Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation construct. Rx Only Provided non Sterile. | There is a possibility that the subject set screw driver could disengage from the torque limiting handle when the counter torque wrench is allowed to contact the counter torque handle. | accessdata.fda.gov |
| January 8, 2016 | 73069 | Class II | Terminated | Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/llium). | There is a possibility that the device may deliver a torque value less than the required setting after initial sterilization. In worst case, the unexpected drop in torque value may lead to the spinal construct loosening and requiring corrective surgical intervention. | accessdata.fda.gov |
| May 18, 2015 | 71297 | Class II | Terminated | ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Standard Implant Grade Titanium Alloy Rx Only Provided Non-Sterile Do Not Reuse | The Firebird Spinal Fixation System 6.5 mm x 55 mm Bone Screw, Self-Tapping is currently mislabeled at the distal tip of the bone screw showing a length measurement of 50 mm instead of 55 mm. | accessdata.fda.gov |
| May 11, 2015 | 71262 | Class II | Terminated | ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill Guides are used to interface with various drill tips during the drilling procedure of bone preparation. | There is a possibility that the thumb button remains in the depressed (unlocked) position allowing the threaded sleeve (drill stop) to unintentionally rotate and change the depth setting. | accessdata.fda.gov |
| November 26, 2013 | 66969 | Class II | Terminated | Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product Usage: The Modular Screw Driver is used for inserting a modular bone screw into the pedicle during a spinal fixation procedure. It is | Orthofix received 6 complaints which resulted in a reportable events due to extended surgical times greater than 30 minutes for the Modular Screw Driver (PN 52-1332). The complaints alleged that the screw driver's collet would malfunction resulting in the surgeon being unable to use the Modular Screw Driver to effectively place Modular Screws, which may resu | accessdata.fda.gov |
| October 29, 2013 | 66660 | Class II | Terminated | Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix Inc., RX Only The Azure Anterior Cervical Plate System is a temporary implant, intended for anterior fixation to th | There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fracture during or after implantation. | accessdata.fda.gov |
| February 1, 2013 | 64265 | Class II | Terminated | Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700). Product Usage: The connector assemblies allow for rod components to be connected side-to-side, or end-to-end and elimin | There is a possibility that the Set Screw (p/n 90-2923) sub-component of the Parallel Rod Connector Assembly (p/n 52-6800) & Axial Rod Connector (p/n 52-6700) may crack during final tightening. Orthofix Inc received six (6) customer complaints related to set screw cracking between November 15, 2010 and December 2012. | accessdata.fda.gov |
| August 6, 2012 | 62804 | Class II | Terminated | Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic Distractor. The ISKD is intended for limb lengthening of the tibia and femur. | There is a possibility that the ISKD limb lengthener may stop distracting post-operatively during treatment, which may result in premature bone consolidation (limb not achieving the desired length) leading to revision surgery to remove and/or replace the device. | accessdata.fda.gov |
| February 6, 2012 | 61117 | Not yet classified | Terminated | Orthofix rotating cutter used in spinal fusion procedures with the FORZA Spacer System. Catalog Number 89-0452 (8mm Rotating Cutter), 89-0454 (10mm Rotating Cutter), and 89-0030 (FORZA Discectomy Case). Manual surgical i | The 8mm and 10mm Rotating Cutters may fracture during use, specifically during disc space preparation. If an 8mm or 10mm Rotating Cutter does Fracture during use, it may result in a surgical delay estimated to be 30 minutes or greater due to preparing the disc space using other instruments or methods and/or retrieving the instrument fragment. | accessdata.fda.gov |
| April 1, 2011 | 58473 | Not yet classified | Terminated | Ratcheting Torque Limiting Handle, Catalog Number 52-1012, Orthofix Spinal Implants, Firebird Spinal Fixation System, Firebird Spinal Fixation System DDD Instrument Case. Product is intended for use with the Set Screw Dr | Upon reaching torque limit, there is a possibility the product may jam or exhibit a ratchet direction switch from forward to reverse. | accessdata.fda.gov |
| October 22, 2010 | 57211 | Not yet classified | Terminated | ORTHOFIX Firebird Spinal Fixation System, Pedicle Screw Spinal System, Reduction Case, Part #68-0111, Lot #16518-LC18. Intended for use in conjunction with Multi-Axial Reduction Screw Assemblies. During assembly of a con | There is a possibility that certain Anti-Splay Caps may not mate properly during assembly of the construct to the Screw Body with Multi-Axial Reduction Screw Assemblies. | accessdata.fda.gov |
| October 22, 2010 | 57199 | Not yet classified | Terminated | BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Bone Screw, Self Tapping, Cannulated. BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Multi-Axial Screw, Self Tapping, Cannulated. | There is a possibility that certain Multi-Axial Screws have spherical heads measuring less than the allowable tolerance. | accessdata.fda.gov |
| October 18, 2010 | 57011 | Not yet classified | Terminated | Orthofix Bone Marrow Aspiration Needle, Catalog number 21-5000, 21-5011, Distributed By: Orthofix Inc, 1720 Bray Central Drive, McKinney, TX 75068-8207. Product includes handle, stylet, cannula, probe, probe guide, and u | Outer cartons for the product may be labeled with incorrect needle gauge. | accessdata.fda.gov |
| November 19, 2009 | 53968 | Not yet classified | Terminated | Orthofix Spinal Implants; Pillar SA PEEK Spacer System Instrument Case. Case contents: Implant Insertion Instrument, Straight Tamp, Bone Awl Drill Guide, Straight Drill, U-Joint Driver with and without retention, Flex Sh | The Pillar SA Implant Insertion Instrument 49-1100 may experience resistance in turning the activation knob while releasing an implant after intra-operative positioning. | accessdata.fda.gov |
| October 9, 2009 | 53578 | Not yet classified | Terminated | Intramedullary Skeletal Kinetic Distractor (ISKD) is an internal limb lengthening device consisting of a telescoping Internal Limb Lengthener, Locking Screws, Instrumentation and an external hand-held Monitor; catalog nu | ISKD lengthening device has the potential for not pre-distracting. This may cause or contribute to device malfunction, and if not discovered prior to use, may require surgical re-intervention or removal. | accessdata.fda.gov |
| September 28, 2007 | 45878 | Not yet classified | Terminated | Orthofix TrueLok External Ring Fixation System, Telescopic Linear Distractor, Threaded in the following sizes: 75mm (Catalog Number: 50-1101), 100mm (Catalog Number: 50-1014), 150mm (Catalog Number: 50-1015) and 200mm (C | Markings reversed: Graduated markings on telescoping bone distractors were reversed, causing the distractors to compress rather than distract the treatment site when adjusted. | accessdata.fda.gov |
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Updated July 14, 2026. 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.