Organization (Industry)
Orthofix (United States)
ClinicalTrials.gov lists Orthofix (United States) as lead sponsor of 27 trials.
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Trials started per year with this organization as sponsor or collaborator, 1990 onward. The series also counts trials where the organization is a collaborator; the lead-sponsor trial count does not.
2026 is partial: 0 registered with a 2026 start date. The dashed outline is the pace from the 0 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 2.8 trial starts a year over the five years to September, under the 5 a year the method needs.
Logo Orthofix, via Wikimedia Commons, CC BY-SA 3.0. Shown to identify the organization; it may be a registered trademark.
This page covers Orthofix (United States): 27 lead-sponsored trials and 2 legal-entity registrations.
Disease areas (20)
Shown in this order: most trials first (counted at this company's own legal-entity record, not the consolidated group).
| Disease area | Trials |
|---|---|
| Intervertebral Disc Degeneration | 7 |
| Fractures, Bone | 6 |
| Leg Length Inequality | 2 |
| Hip Fractures | 2 |
| Fractures, Open | 1 |
Showing 5 of 20 disease areas.
Trials by start year as sponsor or collaborator (15)
Shown in this order: most recent first. 2026 is partial: trials registered with a 2026 start date so far, not a full year.
Show the table of trials by start year as sponsor or collaborator
| Year | Trials started |
|---|---|
| 2025 | 5 |
| 2024 | 5 |
| 2023 | 1 |
| 2022 | 2 |
| 2021 | 3 |
| 2020 | 1 |
| 2019 | 1 |
| 2018 | 1 |
| 2017 | 2 |
| 2016 | 2 |
Showing 10 of 15 years.
Recruitment duration, a model prediction: none of the 27 trials evaluated at the 2026-10-09 snapshot is predicted and still running. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Sponsor delivery record (1)
Enrollment hit target: the share of this sponsor's lead-sponsored trials whose actual enrollment reached the planned enrollment. On time: the share whose actual primary completion date was no later than the planned date. Each share counts only trials where we observed an estimated figure before the actual one, and n is that number of trials. Below 5 trials the count is shown as a fraction, not a percentage.
| Enrollment | Timeline |
|---|---|
| 20% hit target (n=15) | 38% on time (n=16) |
FDA recalls (31)
Shown in this order: most recent first.
| Product | Classification | Initiated |
|---|---|---|
| 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 | Class II | 2018-04-06 |
| Rival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-009C | Class II | 2018-04-06 |
| Rival Reduce Kit Plates, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-012C | Class II | 2018-04-06 |
| 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 X 14MM (002-D-20014); e) D 2.0MM X 16MM (002-D-20016); f) D 2.0MM X 18MM (002-D-20018); g) D 2.0MM X 20MM (002-D-20020); h) D 2.0MM X 22MM (002-D-20022); i) D 2.0MM X 24MM (002-D-20024); j) D 2.0MM X 26MM (002-D-20026); k) D 2.0MM X 28MM (002-D-20028); l) D 2.0MM X 30MM (002-D-20030) | Class II | 2018-04-06 |
| 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); d) D 2.0MM X 14MM (002-E-20014); e) D 2.0MM X 16MM (002-E-20016); f) D 2.0MM X 18MM (002-E-20018); g) D 2.0MM X 20MM (002-E-20020); h) D 2.0MM X 22MM (002-E-20022); i) D 2.0MM X 24MM (002-E-20024); j) D 2.0MM X 26MM (002-E-20026); k) D 2.0MM X 28MM (002-E-20028); l) D 2.0MM X 30MM (002-E-20030) | Class II | 2018-04-06 |
Showing 5 of 31 recalls.
Biomarker capability evidence (4)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| CDIPT | Trial sponsor | Named in trial inclusion criteria |
| CDIPT | Trial sponsor | Named in trial inclusion criteria |
| CDIPT | Trial sponsor | Mentioned in trial text |
| CDIPT | Trial sponsor | Mentioned in trial text |
Not on this page
Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, active development programs, approved assets, sec-reported annual financials, financing and grant events, fda warning letters, fda untitled letters, fda inspection record, fda import refusals, manufacturing and distribution sites, climate targets, as filed, workforce and board diversity, as filed, organization relationships, and clia clinical laboratory certificates.
Counted at group level under Orthofix Medical Inc.: journals published in, us granted patents, latest dated events, and biomarkers this organization publishes on.