Data / Medical devices / Italy / Orthofix SRL
Orthofix SRL: FDA-registered device maker in BUSSOLENGO Verona, Italy, 52 510(k) clearances
Orthofix SRL is registered with the FDA (registration 9680825) in BUSSOLENGO Verona, Italy. It lists 34 device types. The FDA files 52 510(k) clearances under its listings, the newest dated May 19, 2026. 5 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 9680825
- FEI number
- 3002807827
- Address
- Via Delle Nazioni 9, BUSSOLENGO Verona, Italy, 37012
- Owner or operator
- ORTHOFIX SRL (9011783)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- April 6, 2000
- Registered through
- 2027
- Brand names listed
- ADULT LIMB RECONSTRUCTION SYSTEM, ADVANCED LIMB RECONSTRUCTION SYSTEM, ANKLE COMPRESSION NAILING SYSTEM, ANKLE HINDFOOT NAILING SYSTEM, Agile Nail, Allen Wrench, BONE SCREWS, CONTOURS PROXIMAL HUMERAL PLATE (PHP) 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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 19, 2026 | K260146 | FITBONE® TRANSPORT AND LENGTHENING SYSTEM | HSB | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| May 8, 2026 | K253991 | Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA | HSB | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| April 10, 2025 | K250112 | FitboneTM Trochanteric | HSB | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| December 19, 2024 | K242270 | OrthoNext Platform System | QIH | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| December 3, 2024 | K242861 | TrueLok Elevate | KTT | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| June 18, 2024 | K233867 | Fitbone Trochanteric | HSB | Substantially Equivalent | Orthofix Srl | 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 |
| January 18, 2022 | K213572 | JuniOrtho Plating System | HWC | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| November 5, 2021 | K212044 | TrueLok Evo | KTT | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| April 20, 2021 | K210157 | SOLE Medial Column Fusion Plate | HRS | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| February 17, 2021 | K203399 | FITBONE(R) TAA | HSB | Substantially Equivalent | Wittenstein Intens GmbH | accessdata.fda.gov |
| October 27, 2020 | K202519 | OrthoNext Platform System | LLZ | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| May 22, 2020 | K200246 | JPS JuniOrtho Plating System | HRS | Substantially Equivalent | Orthofix Srl | 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 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 |
| February 7, 2018 | K172698 | G-Beam Fusion Beaming System | HWC | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| January 9, 2018 | K172183 | Guided Growth Plate System Plus | OBT | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| December 7, 2017 | K173458 | ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System | HSB | 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 |
| October 12, 2017 | K170146 | Galaxy UNYCO System | KTT | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| May 10, 2017 | K170650 | Orthofix TrueLok Hexapod System (TL-HEX) V2.0 | KTT | Substantially Equivalent | Orthofix Srl | 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 6, 2016 | K153233 | Galaxy UNYCO System | KTT | Substantially Equivalent | Orthofix Srl | 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 |
| November 20, 2013 | K132893 | EDGE ORTHOPAEDICS BITE COMPRESSION SCREW | HWC | Substantially Equivalent | Icon Orthopaedic Concepts Dba Edge Orthopaedics | 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 |
| June 21, 2011 | K110805 | GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL) | OBT | 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 |
| June 10, 2010 | K093442 | GUIDED GROWTH SYSTEM | OBT | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| February 19, 2010 | K093805 | OSCAR 3 | JDX | Substantially Equivalent | Orthosonics, Ltd. | accessdata.fda.gov |
| November 13, 2006 | K062920 | ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP | KTW | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| December 12, 2005 | K053261 | ORTHOFIX TITANIUM NAILING SYSTEMS | HSB | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| September 6, 2005 | K051945 | MIOT PLATING SYSTEM | HRS | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| July 21, 2005 | K051053 | OSCAR, MODEL OE3000DB | JDX | Substantially Equivalent | Orthosonics, Ltd. | accessdata.fda.gov |
| November 16, 2004 | K042766 | ORTHOFIX VOLAR DISTAL RADIAL PLATE | HRS | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| November 20, 2003 | K031493 | GROWTH GUIDANCE PLATE | HRS | Substantially Equivalent | University of Utah/School of Medicine | accessdata.fda.gov |
| January 14, 1999 | K983814 | GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM | JDO | Substantially Equivalent | Efratgo, Ltd. HI Tech Bio-Surgical | accessdata.fda.gov |
| March 18, 1998 | K974186 | ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING | JDW | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| December 19, 1997 | K973944 | ORTHOFIX FEMORAL NAILING SYTEM | HSB | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| May 8, 1996 | K961027 | ORTHOFIX TIBIAL NAILING SYSTEM | HSB | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| March 20, 1996 | K955848 | ORTHOFIX MODULSYSTEM | JDW | Substantially Equivalent | Orthofix, Inc. | accessdata.fda.gov |
| April 4, 1995 | K944092 | ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM | JEC | Substantially Equivalent | Orthofix Srl | accessdata.fda.gov |
| October 3, 1994 | K941048 | TRUE/LOK MONOLATERAL/BILATERAL FIXATOR | LXT | Substantially Equivalent | Applied Osteo Systems, 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 |
|---|---|---|---|---|---|---|
| September 24, 2024 | 96905 | Class II | Ongoing | REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile | Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in having to be replaced. | accessdata.fda.gov |
| September 27, 2018 | 84004 | Class II | Terminated | ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM, RX ONLY, Non Sterile, UDI: (01)18032568031959 | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance. | accessdata.fda.gov |
| January 30, 2018 | 80114 | Class II | Terminated | TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM. The TL-HEX TrueLock Hexapod System (TL-HEX) consists of rings, foot plates and struts to be used in | The firm received complaints regarding the incompatibility and dimensional interference between the double row footplates manufactured in a limited period of 2014 and struts manufactured after September 2016. The firm determined that certain batches of the double row footplates are not compatible with the current version of the TL-HEX struts. | accessdata.fda.gov |
| July 5, 2017 | 77789 | Class II | Terminated | Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO Diaphyseal Femur Box, Gal | The power drill torque limiter may break during use in surgery application. | accessdata.fda.gov |
| February 22, 2010 | 55182 | Not yet classified | Terminated | Orthofix US XCaliber Meta-Diaphyseal Complete Kit, Sterile. 99-91600, manufactured by Orthofix SRL, Via delle Nazioni, 9, 27012 Bussolengo (VR) Italy. Intended for use in the treatment of bone conditions including leg le | During standard quality controls, firm identified a potential for breakage of the XCaliber clamp when locking the cam. | accessdata.fda.gov |
Compare with other makers
- All makers of Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- All makers of Screw, Fixation, Bone
- All makers of Plate, Fixation, Bone
- All makers of Rod, Fixation, Intramedullary And Accessories
- All makers of Scissors, Orthopedic, Surgical
- All makers of Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
Updated May 19, 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.