(84 days)
Not Found
No
The summary describes a mechanical external fixation system with no mention of software, algorithms, or any technology that would suggest AI/ML.
Yes
The device is intended for "treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions," which are therapeutic applications.
No
Explanation: The "Intended Use" section describes the device as a "unilateral external fixation device" for "treatment of bone conditions," and the "Device Description" details its components for fixing bones. There is no mention of diagnosing conditions.
No
The device description explicitly lists various hardware components like frames, bars, pin clamps, pins, accessories, and instruments, indicating it is a physical medical device system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "treatment of bone conditions" using an "external fixation modality." This describes a surgical or therapeutic intervention performed directly on the patient's body.
- Device Description: The description details components like frames, bars, pin clamps, and pins, which are all physical components used to stabilize and manipulate bone externally.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status. IVDs are typically used for diagnosis, monitoring, or screening based on laboratory tests.
Therefore, this device falls under the category of a medical device used for surgical/therapeutic purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
"This product is a unilateral external fixation device, which is intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality."
Product codes
Not Found
Device Description
The Orthofix Dynamic Axial Fixation System, like most external fixation systems, includes various frames, bars, pin clamps, pins, accessories and instruments. The pin clamps enable the frame to be coupled to bone by securing the pins for the intended use. The various components within the system are necessary so that the physician can effectively treat diverse kinds of hard tissue maladies that arise due to differences in the anatomical location and the state of the soft tissues and bone, as well as any peculiarities specific to the individual case.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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): 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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
MAR 2 0 1996
510(k) SUMMARY Orthofix Dynamic Axial Fixation System December 21, 1995
This summary is provided in accordance with the Safe Medical Devices Act of 1990 (SMDA). The information provided in the 510 (k), premarket (on (one information provided in the Superial in the States (and the SMDA, 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
-
- Name of Device:
- Trade/Proprietary Name: A.
Orthofix® Modulsystem
-
B. Common/Usual Name:
Orthofix Dynamic Axial Fixation System -
C. Classification Name:
Smooth or threaded metallic bone fixation fastener
(21 CFR 888.3040) (21 CFR 888.3040).
3. Sponsor/Manufacturer:
ORTHOFIX Srl Via delle Nazioni 9 37012 Bussolengo (VR), Italy Attention: Rolando Stanghellini, Director of Quality Assurance Telephone: 011-39-45-6767030 Facsimile: 011-39-45-6767135
1
Reason for Submitting the 510(k) বী .
The components of the Orthofix Dynamic Axial Fixation System described in this submission have all entered legal distribution in the U.S. as a result of the U.S. Food and Drug Administration's (FDA's) clearance of premarket notification K831576. Premarket notification [510(k)] K831576 was submitted to FDA on behalf of Orthofix by Electro-Biology Inc., (EBI), of Parsippany, New Jersey. All of the components described in this submission that were previously distributed in the U.S. bv EBI, using the Orthofix brand name, were manufactured by Orthofix. The distribution agreement between Orthofix and EBI expired this year, and Orthofix began distributing these same devices through its own wholly owned subsidiary, Orthofix Inc., located in Richardson, Texas.
Orthofix submitted this application to notify FDA of the change in distributors and, thus, to clarify the FDA record.
5. Device Description
The Orthofix Dynamic Axial Fixation System, like most external fixation systems, includes various frames, bars, pin clamps, pins, accessories and instruments. The pin clamps enable the frame to be coupled to bone by securing the pins for the intended use. The various components within the system are necessary so that the physician can effectively treat diverse kinds of hard tissue maladies that arise due to differences in the anatomical location and the state of the soft tissues and bone, as well as any peculiarities specific to the individual case.
6. Intended Use
The intended use of the Orthofix Dynamic Axial Fixation System is unchanged from that previously stated in the original 510(k), K831576. That is, the intended use remains:
"This product is a unilateral external fixation device, which is intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality."
- 3 C + .
P 2 4- 3
2
1 - 1 - 2 2 P 3 = 3
7 . Substantial Equivalence
A listing of all components distributed by Orthofix, Inc. was provided in the submission. A separate listing of all components manufactured by Orthofix and previously distributed by EBI was provided. Additionally, a list delineating the similarities and differences between the two listings was also provided. differences were outlined in the submission. All Additional components added to the Orthofix Dynamic Axial Fixation System since the expiration of the distribution agreement with EBI, were described. They have the same intended use and design characteristics as the components distributed by EBI and are consistent with the original 510(k) K831576.
The manufacturing of Orthofix Dynamic Axial Fixation System components has not been affected by the change in distributors. Further, as stated above, the intended use of the system is unchanged from that previously stated in the original 510(k), K831576.
Labeling for the system remains virtually the same, except for removal of the name "EBI" from all labeling and the issuance of labeling associated with the components marketed subsequent to the expiration of the distribution agreement with EBI. Brochures for the components distributed by Orthofix, Inc. were provided. For purposes of comparison, each Orthofix brochure was immediately followed by the corresponding brochure previously distributed by EBI. Instruction manuals or surgical instructions ("Operative Technique") were, also, provided. These publications provide operative recommendations for clinical use of the Orthofix system.
In conclusion, since the Orthofix Dynamic Axial Fixation System itself remains unaffected by the change in distribution practice, the device is substantially equivalent to itself. The information provided in this 510(k) demonstrates that the components distributed by Orthofix Inc. are identical to the Orthofix components previously distributed by EBI Further, none of the components added following the expiration of the distribution agreement with EBI represent changes which could significantly affect the safety or effectiveness the device and do not alter the substantial of equivalence of the system.