(55 days)
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No
The description focuses solely on the mechanical components and materials of a tibial nailing system, with no mention of software, algorithms, or any AI/ML related terms.
Yes
The device is described as a system for fixation of bone conditions such as fractures and osteotomies, which are treatments for diseases or injuries, fitting the definition of a therapeutic device.
No
The device, the Orthofix Tibial Nailing System, is described as hardware for fixation of fractured bones, including nails, screws, and end caps. Its intended use is for actual treatment (fixation of fractures), not for diagnosing conditions.
No
The device description explicitly states that the system includes physical components such as tibial nails, locking screws, end caps, instruments, and accessories, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states that this system is for the "fixation of the following conditions" and includes "tibial nails of varying diameters and lengths, locking screws and end caps, as well as the instruments and accessories used in their implantation and removal."
- Intended Use: The intended use is for surgically implanting devices to stabilize bone fractures and other conditions. This is a therapeutic intervention, not a diagnostic test performed on a sample.
The device is an implantable orthopedic device used for surgical fixation of bones.
N/A
Intended Use / Indications for Use
The system is indicated for fixation of the following conditions where the area requiring fixation is distal to the tibial tuberosity and at least 55 mm proximal to the distal articular surface: acute traumatic fractures; pathological fractures; delayed or non-unions; stabilization after corrective osteotomy; and bone transport.
Product codes
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Device Description
The Orthofix Tibial Nailing System includes a series of tibial nails of varying diameters and lengths, locking screws and end caps, as well as the instruments and accessories used in their implantation and removal.
The system will include tibial nails which range from 8 to 14 mm in diameter and from 240 to 440 mm in length. These nails are manufactured from surgical grade stainless steel (AISI 316L) and include both solid and cannulated constructions. Nails are included for reamed and unreamed use. The nails have a proximal bend and may contain proximal, intermediate and distal locking holes.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
510(k) SUMMARY Orthofix® Tibial Nailing System March 13, 1996
MAY - 8 1996
This summary is provided in accordance with the Sare Medical Devices Act of 1990 (SMDA). The information provided in the 510(k), premarke notification was in accordance with 21 CFR 807.87 and the SMDA.
1. Submitter of 510(k)
Robert L. Sheridan (Consultant) Vice President, Device Evaluation C.L. McIntosh & Associates, Inc. 12300 Twinbrook Parkway, Suite 625 Rockville, MD 20852
Telephone: (301) 770-9590 Facsimile: (301) 770-9584
2. Name of Device:
-
Trade/Proprietary Name: A.
Orthofix® Tibial Nailing System -
B. Common/Usual Name:
Tibial Nailing System -
C. Classification Name:
"Intramedullary Fixation Rod" (21 CFR 888.3020).
000275
1
Sponsor/Manufacturer: 3.
ORTHOFIX Srl. Via delle Nazioni 9 37012 Bussolengo (VR), Italy
Rolando Stanghellini, Director of Quality Assurance Attention:
Telephone: 011-39-45-6767030 Facsimile: 011-39-45-6767135
4. Reason for Submitting the 510(k)
This 510(k) is submitted to notify FDA of Orthofix's intention to commercially distribute its previously cleared Unreamed Tibial Nail System with additional tibial nails and instrumentation. The current system will include solid and cannulated nails for reamed and unreamed use.
5. Device Description
The Orthofix Tibial Nailing System includes a series of tibial nails of varying diameters and lengths, locking screws and end caps, as well as the instruments and accessories used in their implantation and removal.
The system will include tibial nails which range from 8 to 14 mm in diameter and from 240 to 440 mm in length. These nails are manufactured from surgical grade stainless steel (AISI 316L) and include both solid and cannulated constructions. Nails are included for reamed and unreamed use. The nails have a proximal bend and may contain proximal, intermediate and distal locking holes.
6. Intended Use
The system is indicated for fixation of the following conditions where the area requiring fixation is distal to the tibial tuberosity and at least 55 mm proximal to the distal articular surface: acute traumatic fractures; pathological fractures; delayed or non-unions; stabilization after corrective osteotomy; and bone transport.
2
Substantial Equivalence 7.
The Orthofix Unreamed Tibial Nail System, K912420, originally received 510(k) clearance on September 23, 1991. Orthofix will now offer a greater selection of tibial nails. The nails will include solid and cannulated constructions for reamed and unreamed use. Additional instruments (e.g., reamers) have also been added to the system to meet the surgical requirements of the added tibial nails.
The information provided in this submission demonstrates that the Orthofix Tibial Nailing System with the additions cited remains substantially equivalent to itself and other legally marketed predicate devices, such as the Synthes' Universal & UTN Systems (K914453) and Richards' Russell Taylor System.