(86 days)
Not Found
Not Found
No
The device description focuses on mechanical components and surgical tools, with no mention of AI, ML, image processing, or data analysis.
Yes
The device is intended for stabilizing tibial fractures, directly contributing to the treatment and healing of an injury.
No
The device is indicated for stabilizing tibial fractures, which is a therapeutic rather than a diagnostic function. Its description details its physical characteristics and insertion tools, not any diagnostic capabilities.
No
The device description clearly outlines physical components like a solid cylinder, screws, end caps, an impacting anvil, and an alignment tower, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for stabilizing tibral fractures." This is a therapeutic purpose, directly treating a medical condition within the body.
- Device Description: The description details a physical implant (a nail, screws, and insertion tools) used in surgery. This is a medical device, but not one used for in vitro (outside the body) diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to stabilize a fracture.
N/A
Intended Use / Indications for Use
The Tibia OrthoNail is indicated for stabilizing tibral fractures.
Product codes
888.3020
Device Description
The Tibia OrthoNail is indicated for stabilizing tibral fractures. All implanted components are manufactured from titanium alloy, 6AI-4V, conforming to ASTM B 1840 and in a some fan is indicated for stabilizing tibral fractures. All implanted components are manufactured from titanium alloy, 6AL-4V, conforming to ASTM F 136-92. The components include from thailum alloy, 6AI-4V, conforming to . The Tibia OrthoNail is a solid cylinder. The Tibia OrthoNail is available in diameters, 9 - 14 mm and in lengths of 200 - 425 mm. The device is designed to accept transfixing screws. End caps are provided. For use during insertion an Impacting Anvil is provided. An Alignment Tower is provided to ensure proper alignment of transfixation screw holes. The Anvil has an internal proximal thread for attachment of a slaphammer that is used for insertion or distraction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tibial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
OrthoLogic Corp. Premarket Submission MAR 1 3 1996
945561
OrthoNail 510(k)
510(k) SUMMARY Tibia OrthoNail December 15, 1995
This summary is provided in accordance with the Safe Medical Devices Act of 1990 (SMDA). The information of to provided in accordance with the Safe Medical Devices Act of 1990 (SMDA). The States
Information provided in the 510(k), premarket notification was in accord
1. Submitter of 510(k)
Company Name: OrthoLogic Corp Address: 2850 South 36th Street Phoenix, Arizona 85034
Contact Person: James Koeneman, Ph.D., Vice President of Engineering
Telephone: (602) 437-5520 Fax: (602) 437-5524
2. Name of Device:
Trade/Proprietary Name:
Tibia OrthoNail
Common/Usual Name:
Intramedullary Fixation Device
Classification Name:
21 CFR 888.3020 "Intramedullary Fixation Rod", Class II.
3. Legally Market Predicate Devices
The Tibia OrthoNail is substantially equivalent to many legally marketed intramedullary
fixation devices inluding those listed Table 1 below fixation devices inluding those listed Table 1 below.
4. Device Description
The Tibia OrthoNail is indicated for stabilizing tibral fractures. All implanted components
are manufactured from titanium alloy, 6AI-4V, conforming to ASTM B 1840 and in a some fan is indicated for stabilizing tibral fractures. All implanted components
are manufactured from titanium alloy, 6AL-4V, conforming to ASTM F 136-92. The components include from thailum alloy, 6AI-4V, conforming to
1
The Tibia OrthoNail is a solid cylinder. The Tibia OrthoNail is available in diameters, 9 - 14 mm and in lengths of 200 - 425 mm. The device is designed to accept transfixing screws. End caps are provided. For use during insertion an Impacting Anvil is provided. An Alignment Tower is provided to ensure proper alignment of transfixation screw holes. The Anvil has an internal proximal thread for attachment of a slaphammer that is used for insertion or distraction.
| Table 1 |
|---|
| Comparison of Technological Characteristics |
| Predicate Devices and the Tibia OrthoNail |
| Manufacturer | OrthoLogic | Applied Osteo
Systems | Richards |
|-------------------------------|-------------------|--------------------------|-----------------|
| Device | OrthoNail | True/Flex | Russell-Taylor |
| Technologic
Characteristic | | | |
| Tibial | yes | yes | yes |
| Solid Section | Yes | Yes | Yes |
| Transfixation
Holes | Yes | Yes | Yes |
| Material | Titanium
Alloy | Titanium
Alloy | Stainless Steel |
| Diameter | 9 - 14mm | 9, 10 mm | 11-14 mm |
| Length | 200 - 425 mm | 285 - 390mm | 285 - 380 mm |
Based on the information provided, the Tibia OrthoNail is substantially equivalent to legally marketed predicate devices.
510(k)