Orthofix Srl: FDA filings under this applicant name
FDA lists 38 510(k) clearances under the applicant name “Orthofix Srl” (first 1995, latest 2026), across 11 product codes in 2 review panels. Median 510(k) review time under this name: 116 days. Since 2017 the median was 119 days, against 117 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 144 |
| 2013 | 0 | — |
| 2014 | 5 | 130 |
| 2015 | 1 | 55 |
| 2016 | 1 | 58 |
| 2017 | 5 | 68 |
| 2018 | 4 | 164 |
| 2019 | 1 | 108 |
| 2020 | 2 | 84 |
| 2021 | 2 | 108 |
| 2022 | 1 | 69 |
| 2023 | 0 | — |
| 2024 | 5 | 195 |
| 2025 | 1 | 84 |
| 2026 | 2 | 133 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Orthofix Srl took a median 119 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 117 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | 12 | 12 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 11 | 11 |
| HRS | Plate, Fixation, Bone | 4 | 4 |
| HWC | Screw, Fixation, Bone | 2 | 2 |
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | 2 | 2 |
| OBT | Plate, Bone, Growth Control, Pediatric, Epiphysiodesis | 2 | 2 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
| JDW | Pin, Fixation, Threaded | 1 | 1 |
| JEC | Component, Traction, Invasive | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Plus 1 more product codes.
Review panels
- Orthopedic (36)
- Radiology (2)
Most recent Orthofix Srl 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260146 | FITBONE® TRANSPORT AND LENGTHENING SYSTEM | HSB | 2026-05-19 | 119 |
| K253991 | Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA | HSB | 2026-05-08 | 147 |
| K250112 | FitboneTM Trochanteric | HSB | 2025-04-10 | 84 |
| K242270 | OrthoNext Platform System | QIH | 2024-12-19 | 140 |
| K242861 | TrueLok Elevate | KTT | 2024-12-03 | 74 |
| K233867 | Fitbone Trochanteric | HSB | 2024-06-18 | 195 |
| K232648 | RODEO Telescopic Nail | HSB | 2024-05-03 | 246 |
| K232169 | FITBONE® Transport and Lengthening System | HSB | 2024-03-22 | 245 |
| K213572 | JuniOrtho Plating System | HWC | 2022-01-18 | 69 |
| K212044 | TrueLok Evo | KTT | 2021-11-05 | 128 |
28 earlier clearances. See the full list in Caduvo.
Recalls
36 product recalls in 5 recall events; 1 initiated in the last five years. Most recent: 2024-09-24.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Orthofix, Inc. (60 510(k)s)
- Orthofix US, LLC (4 510(k)s)
- Orthofix Medical, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Orthofix Srl?
FDA lists 38 510(k) clearances under the applicant name “Orthofix Srl” (first 1995, latest 2026), across 11 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Orthofix Srl?
The median time from FDA receipt to decision across 510(k)s cleared under the name Orthofix Srl is 116 days. Since 2017: 119 days, versus 117 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Orthofix Srl?
The most frequent FDA product codes under this applicant name are HSB (Rod, Fixation, Intramedullary And Accessories, 12); KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, 11); HRS (Plate, Fixation, Bone, 4).
Next steps
- See all 38 Orthofix Srl clearances with predicates and recalls
- Run predicate analysis for product code HSB, Orthofix Srl's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.