(546 days)
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Dwyer Spinal Instrumentation, Kaneda Anterior System, ISOLA Anterior System
No
The document describes a mechanical spinal implant system and its intended use and performance testing, with no mention of AI or ML technologies.
Yes
The text states the device is "intended for use in anterior instrumentation and afusion for for kyphotic decompression deformities, post traumatic kyphotic deformities, degenerative disc disease... burst fractures, tumors and previous failed surgery of the spine," which are therapeutic applications.
No
Explanation: This device is an implantable surgical system used for anterior instrumentation and fusion of the spine. It is a treatment device, not a diagnostic one, as it does not gather or analyze data for the purpose of identifying a disease or condition.
No
The device description explicitly states it is a "construct consisting of implant grade titanium alloy dynamized closed screws, closed transverse fixator connector, anterior rods and a closed blocker," which are physical hardware components.
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, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Anterior Dynamized system is a surgical implant used for anterior instrumentation and fusion of the spine. It is a physical device implanted into the body to treat specific spinal conditions.
- Lack of IVD Characteristics: There is no mention of testing biological samples, analyzing biomarkers, or providing diagnostic information based on laboratory analysis.
Therefore, the Anterior Dynamized system falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Anterior Dynamized system is intended for use in anterior instrumentation and afusion for for kyphotic decompression deformities, post traumatic kyphotic deformities, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), burst fractures, tumors and previous failed surgery of the spine. The intended levels for treatment range from T10 to L3.
Product codes
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Device Description
The Anterior Dynamized system is a construct consisting of implant grade titanium alloy dynamized closed screws, closed transverse fixator connector, anterior rods and a closed blocker. The Anterior Dynamized construct allows continual compression of the bone graft while avoiding hyperextension type forces on the The components of the Anterior Dynamized system construct. have been designed with anatomic limitations in mind.
Dynamized Closed Screws:
The dynamized closed screw is manufactured from a single rod of implant grade titanium alloy material into two distinct sections; the cancellous thread and rod interface. Multiple lengths are available to allow for surgeon latitude. The closed screw allows superior to inferior or inferior to superior placement of a rod. Closed screws used in the caudal portion of the construct contain a set screw which is designed to affix the rod into the opening of the closed screw. Closed screws used in the cephalad portion of the construct do not use a set screw to allow for longitudinal movement of the construct along the rods. The set screw is precision machined from the same implant grade titanium alloy material. The dynamized closed screw is placed into the vertebral body of the spine. Four dynamized closed screws are used per construct.
Closed Transverse Fixator Connector:
The closed transverse fixator connector is composed of two closed transverse connectors and a transverse fixator plate. The closed transverse connectors are designed with the patented V-Groove Hollow-Ground (VHG) design to allow proper seating of the titanium rod. A transverse fixator plate is used to span the gap between the connectors. The fixator plates are machined with two elongated slots which facilitate horizontal positioning of the plate. The transverse plates are available in two sizes, small and large. The rod is secured to the connector and transverse plate with a set screw and hex nut. Two closed transverse fixator connectors are used per construct.
Closed Blocker:
The closed blocker is of the same design as a closed transverse connector. Using a set screw, the closed blocker is attached to the anterior rod above the dynamized closed screw. The closed blocker is designed to stop hyperextension type forces on the construct. One closed blocker is required per construct.
Anterior Rod:
The titanium alloy rod is offered in 1/4 inch outer diameter and two lengths are available for that diameter; 18.0mm and 24.0mm. Two rods are required in the construct and are cut to the appropriate length during the procedure
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
Spine, T10 to L3
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)
Non-Clinical:
Static compression bending and torsion were performed on the Anterior Dynamized bi-level construct to characterize the properties of stiffness, strength, and maximum applied moment Dynamic bending compression testing was also (torque). performed to characterize fatigue life.
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.
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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.
Dwyer Spinal Instrumentation, Kaneda Anterior System, ISOLA Anterior System
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
ALC Dynamized Fixation System 510(k) Summary
| COMPANY: | AcroMed Corporation
3303 Carnegie Avenue
Cleveland, Ohio 44115 |
|-------------|----------------------------------------------------------------------|
| TRADE NAME: | ALC Dynamized Fixation System |
| FEB 1 9 1997 | |
|---|---|
| -- | -------------- |
CLASSIFICATION: Spinal intervertebral body fixation orthosis. Class II
DESCRIPTION:
The Anterior Dynamized system is a construct consisting of implant grade titanium alloy dynamized closed screws, closed transverse fixator connector, anterior rods and a closed blocker. The Anterior Dynamized construct allows continual compression of the bone graft while avoiding hyperextension type forces on the The components of the Anterior Dynamized system construct. have been designed with anatomic limitations in mind.
Dynamized Closed Screws:
The dynamized closed screw is manufactured from a single rod of implant grade titanium alloy material into two distinct sections; the cancellous thread and rod interface. Multiple lengths are available to allow for surgeon latitude. The closed screw allows superior to inferior or inferior to superior placement of a rod. Closed screws used in the caudal portion of the construct contain a set screw which is designed to affix the rod into the opening of the closed screw. Closed screws used in the cephalad portion of the construct do not use a set screw to allow for longitudinal movement of the construct along the rods. The set screw is precision machined from the same implant grade titanium alloy material. The dynamized closed screw is placed into the vertebral body of the spine. Four dynamized closed screws are used per construct.
1
Closed Transverse Fixator Connector:
The closed transverse fixator connector is composed of two closed transverse connectors and a transverse fixator plate. The closed transverse connectors are designed with the patented V-Groove Hollow-Ground (VHG) design to allow proper seating of the titanium rod. A transverse fixator plate is used to span the gap between the connectors. The fixator plates are machined with two elongated slots which facilitate horizontal positioning of the plate. The transverse plates are available in two sizes, small and large. The rod is secured to the connector and transverse plate with a set screw and hex nut. Two closed transverse fixator connectors are used per construct.
Closed Blocker:
The closed blocker is of the same design as a closed transverse connector. Using a set screw, the closed blocker is attached to the anterior rod above the dynamized closed screw. The closed blocker is designed to stop hyperextension type forces on the construct. One closed blocker is required per construct.
Anterior Rod:
The titanium alloy rod is offered in 1/4 inch outer diameter and two lengths are available for that diameter; 18.0mm and 24.0mm. Two rods are required in the construct and are cut to the appropriate length during the procedure
PERFORMANCE DATA:
Non-Clinical:
Static compression bending and torsion were performed on the Anterior Dynamized bi-level construct to characterize the properties of stiffness, strength, and maximum applied moment Dynamic bending compression testing was also (torque). performed to characterize fatigue life.
2
INDICATIONS:
The Anterior Dynamized system is intended for use in anterior instrumentation and afusion for for kyphotic decompression deformities, post traumatic kyphotic deformities, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), burst fractures, tumors and previous failed surgery of the spine. The intended levels for treatment range from T10 to L3.
SUBSTANTIAL EQUIVALENCY:
Dwyer Spinal Instrumentation Kaneda Anterior System ISOLA Anterior System