Medical device manufacturer
Orthofix, Inc.
Orthofix, Inc. holds 98 FDA 510(k) clearances across 23 product codes. Median elapsed review time is 88 days. openFDA lists 75 recall records naming the company. FDA publishes it under 11 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 98
- Product codes
- 23
- Median review
- 88 days
- Recall records
- 75
How does FDA spell Orthofix, Inc.?
FDA publishes this company under 11 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| ORTHOFIX SRL | device/registrationlisting | normalised |
| Orthofix | device/510k | normalised |
| Orthofix Inc | device/recall | normalised |
| Orthofix Srl | device/510k | normalised |
| Orthofix Srl | device/enforcement | normalised |
| Orthofix Srl | device/recall | normalised |
| Orthofix, Inc | device/enforcement | normalised |
| Orthofix, Inc | device/recall | normalised |
Showing 8 of 11.
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Orthofix, Inc. file in?
23 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | 14 | 119 days | |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 11 | 128 days | |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 10 | 90 days | |
| NKB | Thoracolumbosacral Pedicle Screw System | 9 | 73 days | |
| HRS | Plate, Fixation, Bone | 7 | 100 days | |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 7 | 112 days | |
| NKG | Posterior Cervical Screw System | 7 | 49 days | |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 5 | 85 days | |
| OUR | Sacroiliac Joint Fixation | 5 | 29 days | |
| OBT | Plate, Bone, Growth Control, Pediatric, Epiphysiodesis | 4 | 90 days | |
| HWC | Screw, Fixation, Bone | 2 | 69 days | |
| JDW | Pin, Fixation, Threaded | 2 | 84 days | |
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | 2 | 30 days | |
| KWP | Appliance, Fixation, Spinal Interlaminal | 2 | 27 days | |
| OLO | Orthopedic Stereotaxic Instrument | 2 | 146 days | |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 2 | 42 days | |
| FMF | Syringe, Piston | 1 | 53 days | |
| HTY | Pin, Fixation, Smooth | 1 | 49 days | |
| JEC | Component, Traction, Invasive | 1 | 225 days | |
| LLZ | System, Image Processing, Radiological | 1 | 56 days | |
| LZK | Implant, Malar | 1 | 88 days | |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 1 | 140 days | |
| QIH | Automated Radiological Image Processing Software | 1 | 140 days |
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Orthofix, Inc. had a recall?
openFDA lists 75 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-1977-2025Class IIOpen, ClassifiedHSB
Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in having to be replaced.
Z-0373-2020Class IITerminatedJDW
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
Z-0374-2020Class IITerminatedJDW
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
Z-0375-2020Class IITerminatedJDW
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
Z-0376-2020Class IITerminatedJDW
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
Showing the 5 most recently initiated of 75.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Orthofix, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K260146 | FITBONE® TRANSPORT AND LENGTHENING SYSTEM | HSB | 119 | |
| K253991 | Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA | HSB | 147 | |
| K250112 | FitboneTM Trochanteric | HSB | 84 | |
| K242270 | OrthoNext Platform System | QIH | 140 | |
| K242861 | TrueLok Elevate | KTT | 74 | |
| K233867 | Fitbone Trochanteric | HSB | 195 | |
| K240749 | PILLAR SA Ti Spacer System (82-XXX) | MAX | 70 | |
| K232648 | RODEO Telescopic Nail | HSB | 246 | |
| K232169 | FITBONE® Transport and Lengthening System | HSB | 245 | |
| K213572 | JuniOrtho Plating System | HWC | 69 |
Source: openFDA device/510k · retrieved
Where is Orthofix, Inc. registered?
FDA lists 1 registered establishment for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Orthofix, Inc. files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.