Orthofix US, LLC: FDA filings under this applicant name
FDA lists 4 510(k) clearances under the applicant name “Orthofix US, LLC” (first 2022, latest 2025), plus 1 PMA decision, across 5 product codes in 2 review panels. Median 510(k) review time under this name: 180 days. Since 2017 the median was 180 days, against 106 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 |
|---|---|---|
| 2022 | 2 | 136 |
| 2023 | 1 | 239 |
| 2024 | 0 | — |
| 2025 | 1 | 121 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Orthofix US, LLC took a median 180 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 106 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| LOF | Stimulator, Bone Growth, Non-Invasive | 1 | 0 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 | 1 |
Review panels
- Orthopedic (4)
- Radiology (1)
Most recent Orthofix US, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252088 | Firebird SI Navigation System | OLO | 2025-10-31 | 121 |
| K230252 | OFIX MIS App | LLZ | 2023-09-26 | 239 |
| K211712 | 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System | KWQ | 2022-02-11 | 253 |
| K213951 | FORZA XP Expandable Spacer System | MAX | 2022-01-05 | 19 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P210035 | PMA | AccelStimTM Bone Growth Stimulator | 2022-05-03 |
Recalls
openFDA lists no recalls under a recalling firm named Orthofix US, LLC.
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 Srl (38 510(k)s)
- Orthofix Medical, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Orthofix US, LLC?
FDA lists 4 510(k) clearances under the applicant name “Orthofix US, LLC” (first 2022, latest 2025), plus 1 PMA decision, across 5 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 US, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Orthofix US, LLC is 180 days. Since 2017: 180 days, versus 106 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Orthofix US, LLC?
The most frequent FDA product codes under this applicant name are KWQ (Appliance, Fixation, Spinal Intervertebral Body, 1); LLZ (System, Image Processing, Radiological, 1); LOF (Stimulator, Bone Growth, Non-Invasive, 1).
Next steps
- See all 4 Orthofix US, LLC clearances with predicates and recalls
- Run predicate analysis for product code KWQ, Orthofix US, LLC'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.