Orthofix, Inc.: FDA filings under this applicant name
FDA lists 60 510(k) clearances under the applicant name “Orthofix, Inc.” (first 1996, latest 2024), plus 2 PMA decisions, across 17 product codes in 3 review panels. Median 510(k) review time under this name: 86 days. Since 2017 the median was 69 days, against 93 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 | 4 | 125 |
| 2013 | 3 | 62 |
| 2014 | 4 | 176 |
| 2015 | 6 | 170 |
| 2016 | 6 | 98 |
| 2017 | 5 | 69 |
| 2018 | 4 | 174 |
| 2019 | 2 | 103 |
| 2020 | 8 | 30 |
| 2021 | 5 | 86 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 70 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Orthofix, Inc. took a median 69 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 93 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 10 | 10 |
| NKB | Thoracolumbosacral Pedicle Screw System | 9 | 9 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 7 | 7 |
| NKG | Posterior Cervical Screw System | 7 | 7 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 5 | 5 |
| OUR | Sacroiliac Joint Fixation | 5 | 5 |
| HRS | Plate, Fixation, Bone | 3 | 3 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 2 | 2 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 2 | 2 |
| LOF | Stimulator, Bone Growth, Non-Invasive | 2 | 0 |
Plus 7 more product codes.
Review panels
Most recent Orthofix, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240749 | PILLAR SA Ti Spacer System (82-XXX) | MAX | 2024-05-28 | 70 |
| 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 | 2021-08-31 | 89 |
| 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 | 2021-07-30 | 57 |
| K210667 | FIREBIRD SI Fusion System | OUR | 2021-03-25 | 20 |
| K203342 | CONSTRUX Mini Ti Spacer System | ODP | 2021-03-18 | 125 |
| K203576 | FORZA Ti Spacer System | MAX | 2021-03-03 | 86 |
| K203138 | FIREBIRD SI Fusion System | OUR | 2020-11-18 | 29 |
| K202949 | CONSTRUX Mini PEEK Spacer System | ODP | 2020-10-29 | 29 |
| K202666 | CONSTRUX Mini PTC Spacer System | ODP | 2020-10-14 | 30 |
| K201664 | FIREBIRD SI Fusion System | OUR | 2020-09-15 | 88 |
50 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P030034 | PMA | CERVICAL-STIM MODEL 505L CERVICAL FUSION SYSTEM | 2004-12-23 |
| P850007 | PMA | PHYSIO-STIM(TM) I & II MODEL 6000 & 7000 | 1986-02-21 |
Recalls
39 product recalls in 19 recall events; 0 initiated in the last five years. Most recent: 2018-04-06.
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.
Device clinical trials
An industry sponsor named Orthofix, Inc. is the lead sponsor of 6 device studies on ClinicalTrials.gov (4 active or recruiting). Most recent:
- NCT07286357: A Data Collection Protocol to Evaluate the Real World Usage of the Orthofix AccelStim Device to Treat Fresh Metatarsal Fractures (Active not recruiting, started 2025-05-30)
- NCT07282067: Orthofix PhysioStim PEMF Ankle Fusion Retrospective (Active not recruiting, started 2025-01-23)
- NCT05082090: A Multi-Center Post-Market Data Collection Protocol to Evaluate the Performance of Orthofix Spine Devices (Active not recruiting, started 2021-09-15)
- NCT04982835: M6-C Artificial Cervical Disc Two-Level IDE Pivotal Study (Active not recruiting, started 2021-07-26)
- NCT03177473: Study Using the CervicalStim Device Following Cervical Fusion (Completed, started 2017-06-28)
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 Srl (38 510(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, Inc.?
FDA lists 60 510(k) clearances under the applicant name “Orthofix, Inc.” (first 1996, latest 2024), plus 2 PMA decisions, across 17 product codes in 3 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, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Orthofix, Inc. is 86 days. Since 2017: 69 days, versus 93 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Orthofix, Inc.?
The most frequent FDA product codes under this applicant name are ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 10); NKB (Thoracolumbosacral Pedicle Screw System, 9); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 7).
Next steps
- See all 60 Orthofix, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ODP, Orthofix, Inc.'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.