Company · US
Orthofix Srl
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2026. Name variants (Inc, Corp, punctuation) are merged.
98510(k) clearances (2 in 12 months)
75recalls (0 in 12 months)
73recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HRS | Plate, Fixation, Bone | 27 |
| JDW | Pin, Fixation, Threaded | 25 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 23 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 17 |
| NKB | Thoracolumbosacral Pedicle Screw System | 14 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 10 |
| NKG | Posterior Cervical Screw System | 9 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 8 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 6 |
| OUR | Sacroiliac Joint Fixation | 5 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 4 |
| OBT | Plate, Bone, Growth Control, Pediatric, Epiphysiodesis | 4 |
| HWC | Screw, Fixation, Bone | 2 |
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | 2 |
| OLO | Orthopedic Stereotaxic Instrument | 2 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 2 |
| FMF | Syringe, Piston | 1 |
| FZX | Guide, Surgical, Instrument | 1 |
| HTY | Pin, Fixation, Smooth | 1 |
| HXC | Wrench | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 19, 2026 | K260146 | FITBONE® TRANSPORT AND LENGTHENING SYSTEM Orthofix Srl, IT | HSB |
| May 8, 2026 | K253991 | Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA Orthofix Srl, IT | HSB |
| Apr 10, 2025 | K250112 | FitboneTM Trochanteric Orthofix Srl, IT | HSB |
| Dec 19, 2024 | K242270 | OrthoNext Platform System Orthofix Srl, IT | QIH |
| Dec 3, 2024 | K242861 | TrueLok Elevate Orthofix Srl, IT | KTT |
| Jun 18, 2024 | K233867 | Fitbone Trochanteric Orthofix Srl, IT | HSB |
| May 28, 2024 | K240749 | PILLAR SA Ti Spacer System (82-XXX) Orthofix, Inc. | MAX |
| May 3, 2024 | K232648 | RODEO Telescopic Nail Orthofix Srl, IT | HSB |
| Mar 22, 2024 | K232169 | FITBONE® Transport and Lengthening System Orthofix Srl, IT | HSB |
| Jan 18, 2022 | K213572 | JuniOrtho Plating System Orthofix Srl, IT | HWC |
| Nov 5, 2021 | K212044 | TrueLok Evo Orthofix Srl, IT | KTT |
| Aug 31, 2021 | K211704 | CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer Orthofix, Inc. | ODP |
| Jul 30, 2021 | K211710 | Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Def Orthofix, Inc. | NKG |
| Apr 20, 2021 | K210157 | SOLE Medial Column Fusion Plate Orthofix Srl, IT | HRS |
| Mar 25, 2021 | K210667 | FIREBIRD SI Fusion System Orthofix, Inc. | OUR |
| Mar 18, 2021 | K203342 | CONSTRUX Mini Ti Spacer System Orthofix, Inc. | ODP |
| Mar 3, 2021 | K203576 | FORZA Ti Spacer System Orthofix, Inc. | MAX |
| Nov 18, 2020 | K203138 | FIREBIRD SI Fusion System Orthofix, Inc. | OUR |
| Oct 29, 2020 | K202949 | CONSTRUX Mini PEEK Spacer System Orthofix, Inc. | ODP |
| Oct 27, 2020 | K202519 | OrthoNext Platform System Orthofix Srl, IT | LLZ |
| Oct 14, 2020 | K202666 | CONSTRUX Mini PTC Spacer System Orthofix, Inc. | ODP |
| Sep 15, 2020 | K201664 | FIREBIRD SI Fusion System Orthofix, Inc. | OUR |
| Jun 15, 2020 | K201481 | Centurion POCT System Orthofix, Inc. | NKG |
| May 22, 2020 | K200246 | JPS JuniOrtho Plating System Orthofix Srl, IT | HRS |
| May 1, 2020 | K200606 | O-Genesis Graft Delivery System Orthofix, Inc. | FMF |
| Apr 9, 2020 | K200052 | CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System Orthofix, Inc. | ODP |
| Apr 2, 2020 | K200696 | FIREBIRD SI Fusion System Orthofix, Inc. | OUR |
| Jun 7, 2019 | K190388 | RIVAL View Plating Systems and Reduce Fracture Plating Systems Orthofix Srl, IT | HRS |
| May 22, 2019 | K190751 | Connector System Orthofix, Inc. | NKG |
| Apr 30, 2019 | K183342 | SambaScrew 3D SI Fusion System Orthofix, Inc. | OUR |
| Aug 24, 2018 | K180179 | Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Pho Orthofix, Inc. | NKB |
| May 15, 2018 | K180624 | Guided Growth Plate System Plus Orthofix Srl, IT | OBT |
| Apr 23, 2018 | K172699 | Agile Nail Orthofix Srl, IT | HSB |
| Mar 8, 2018 | K172115 | Navigated Instrument System Orthofix, Inc. | OLO |
| Feb 7, 2018 | K172698 | G-Beam Fusion Beaming System Orthofix Srl, IT | HWC |
| Jan 22, 2018 | K180025 | Centurion POCT System Orthofix, Inc. | NKG |
| Jan 19, 2018 | K172696 | FORZA® XP Expandable Spacer System Orthofix, Inc. | MAX |
| Jan 9, 2018 | K172183 | Guided Growth Plate System Plus Orthofix Srl, IT | OBT |
| Dec 7, 2017 | K173458 | ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System Orthofix Srl, IT | HSB |
| Nov 16, 2017 | K173051 | Orthofix MJ-FLEX THE NEW METAIZEAU NAIL Orthofix Srl, IT | HTY |
| Nov 2, 2017 | K172437 | CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System Orthofix, Inc. | ODP |
| Oct 12, 2017 | K170146 | Galaxy UNYCO System Orthofix Srl, IT | KTT |
| Aug 18, 2017 | K172194 | Connector System Orthofix, Inc. | NKG |
| May 11, 2017 | K170647 | Connector System Orthofix, Inc. | NKG |
| May 10, 2017 | K170650 | Orthofix TrueLok Hexapod System (TL-HEX) V2.0 Orthofix Srl, IT | KTT |
| May 5, 2017 | K171082 | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spina Orthofix, Inc. | NKB |
| Mar 13, 2017 | K162921 | Navigated Instrument System Orthofix, Inc. | OLO |
| Jan 24, 2017 | K161466 | ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System Orthofix Srl, IT | HSB |
| Dec 22, 2016 | K162446 | FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System Orthofix, Inc. | MAX |
| Dec 16, 2016 | K162638 | CETRA Anterior Cervical Plate System Orthofix, Inc. | KWQ |
Newest 50 of 98.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2025 | Orthofix Srl REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile Open, Classified |
HSB | K233867 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-93601, GALAXY WRIST STERILE KIT, UDI: (01)18054242511656 Terminated |
KTT | K141760 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-93504,
ELBOW STERILE KIT, UDI: (01)18054242511533 Terminated |
KTT | K113770 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-93503US,
ANKLE TRANSFIX PIN STERILE KIT, UDI: (01)18054242511304 Terminated |
KTT | K113770 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref:99-93503 ,
ANKLE STERILE KIT, UDI: (01)18033509859922 Terminated |
KTT | K113770 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-93502US, TIBIA FEMUR DIAPHYSEAL STERILE KIT, UDI: (01)18054242S511298 Terminated |
KTT | K113770 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510895 Terminated |
KTT | K113770 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-93502,
LOWER LIMB DIAPHYSEAL STERILE KIT, RX ONLY, UDI: (01)18033509859915 Terminated |
KTT | K113770 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-93501US, PELVIS STERILE KIT, RX ONLY, UDI: (01)180S4242S11281 Terminated |
KTT | K113770 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-93501JP, PELVIS STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510888 Terminated |
KTT | K113770 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-93501, PELVIS STERILE KIT, RX ONLY, UDI: (01)18033509859908 Terminated |
KTT | K113770 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERILE, RX ONLY, UDI: (01)18033509855979 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-92503, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG SCREWS, RX ONLY, UDI: (01)
18033509855962 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-92502,
PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SCREWS, RX ONLY, UDI: (01) 18033509855955 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS, RX ONLY, UDI: (01) 18033509855948 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-91647UE, UE XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937169719 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-91647, US XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937167791 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-91600UE, UE XCALIBER METADIAPHYSEAL COMPLETE KIT, RX ONLY, UDI: (01)18032937169696 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-36501,
RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM- STERILE, RX ONLY, UDI: (01)18032568861648 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref 1-1355001, DRILL BIT D.2,7 MM L.127 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242S10918 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref 1-1300301,DRILL BIT D.3,2 MM L.140 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242510901 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref 1-1100701,DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856099 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856075 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref 1-1100201,DRILL BIT Diameter .4,8 MM L.240 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856068 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18032568039603 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref 1355001, drill bit diameter 2.7 MM LENGTH 127MM, RX ONLY, Non Sterile, UDI: (01)18032568033 137 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref 1100701, drill bit diameter 4.8 MM LENGTH 280MM, RX ONLY, Non Sterile, UDI: (01)18032568031966 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref 1100301, drill bit diameter 3.2 MM LENGTH 200 MM, RX ONLY, Non Sterile, UDI: (01)18032568031911 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref 1100201, drill bit diameter 4.8 MM LENGTH 240 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref 1100101, drill bit diameter 4.8 MM LENGTH 180 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref 13550, drill bit diameter 2.7 MM LENGTH 127 MM, RX ONLY, Non Sterile, UDI: (01)18032568033120 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM, RX ONLY, Non Sterile, UDI: (01)18032568031959 Terminated |
JDW | K955848 |
| Jun 7, 2018 | Orthofix, Inc Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-C-01001); b) Large (003-C-02001) Terminated |
HRS | K140876 |
| Jun 7, 2018 | Orthofix, Inc T-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-B-01001); b) Large (003-B-02001) Terminated |
HRS | K140876 |
| Jun 7, 2018 | Orthofix, Inc TN Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-F-01020); b) Medium (002-F-01025);
c) Large (002-F-01030) Terminated |
HRS | K140876 |
| Jun 7, 2018 | Orthofix, Inc Straight Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Holes (Part Number): a) 3 Hole (003-D-01001); b) 4 Hole (003-D-02001); c) 6 Hole (003-D-03001) Terminated |
HRS | K140876 |
| Jun 7, 2018 | Orthofix, Inc MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-B-01001); b) Medium (002-B-02002);
c) Large (002-B-03003) Terminated |
HRS | K140876 |
| Jun 7, 2018 | Orthofix, Inc L-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Left or Right (Part Number): a) Left (003-E-00001L); b) Right (003-E-00001R) Terminated |
HRS | K140876 |
| Jun 7, 2018 | Orthofix, Inc Lapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size/Step/Left or Right (Part Number):
a) Small/0MM Step/Left (002-C-01000L);
b) Small/0MM Step/Right (002-C-01000R);
c) Large/0MM St Terminated |
HRS | K140876 |
| Jun 7, 2018 | Orthofix, Inc H-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number):
a) 12MM Spacer (003-H-12001);
b) 15MM Spacer (003-H-15001);
20MM Spacer (003-H-20001);
25MM Spacer (003-H-25001);
3 Terminated |
HRS | K142135 |
| Jun 7, 2018 | Orthofix, Inc Evans Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 6MM Spacer (002-H-00006);
b) 8MM Spacer (022-H-00008);
c) 10MM Spacer (002-H-00010);
d) 12MM Spacer (002-H-0001 Terminated |
HRS | K140876 |
| Jun 7, 2018 | Orthofix, Inc CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-G-01020);
b) Medium (002-G-01025);
c) Large (002-G-01030) Terminated |
HRS | K140876 |
| Jun 7, 2018 | Orthofix, Inc Box Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 18MM (003-F-18001);
b) 22MM (003-F-22001);
c) 30MM (003-F-30001) Terminated |
HRS | K142135 |
| Jun 7, 2018 | Orthofix, Inc Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 3.2MM X 10MM (002-E-32010)
b) D 3.2MM X 12MM (002-E-32012)
c) D 3.2MM X 14MM (002-E-32014)
d) D 3.2MM X 16MM ( Terminated |
HRS | K140876 |
| Jun 7, 2018 | Orthofix, Inc Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a)D 3.2MM X 10MM (002-D-32010)
b) D 3.2MM X 12MM (002-D-32012)
c) D 3.2MM X 14MM (002-D-32014)
d) D 3.2MM X 16M Terminated |
HRS | K140876 |
| Jun 7, 2018 | Orthofix, Inc Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 2.7MM X 8MM (002-E-27008),
b) D 2.7MM X 10MM (002-E-27010);
c) D 2.7MM X 12MM (002-E-27012);
d) D 2.7MM X 14MM Terminated |
HRS | K140876 |
| Jun 7, 2018 | Orthofix, Inc Non-Locking Screw, D 2.7MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Numbers): a) D 2.7MM X 8MM (002-D-27008);
b) D 2.7MM X 10MM (002-D-27010);
c) D 2.7MM X 12MM (002-D-270 Terminated |
HRS | K140876 |
| Jun 7, 2018 | Orthofix, Inc Locking Screw, D 2.0MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (002-E-20008); b) D 2.0MM X 10MM (002-E-20010);
c) D 2.0MM X 12MM (002-E-20012);
Terminated |
HRS | K140876 |
| Jun 7, 2018 | Orthofix, Inc Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (0002-D-20008); b) D 2.0MM X 10MM (002-D-20010);
c) D 2.0MM X 12MM (002-D-20012);
d) D 2.0MM Terminated |
HRS | K140876 |
| Jun 7, 2018 | Orthofix, Inc Rival Reduce Kit Plates, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-012C Terminated |
HRS | K142135 |
Newest 50 of 75.