(64 days)
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No
The device description focuses on the mechanical components and materials of an external fixation system, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is an external fixation system used to address fractures, which is a therapeutic purpose.
No.
The device description clearly states its purpose is for external fixation to address fractures and osteotomies, acting as a tool in surgery to hold pins and provide fracture reduction and alignment. There is no mention of it being used for diagnosis or generating diagnostic information.
No
The device description explicitly states it consists of an external fixation device and threaded guide pins, which are physical hardware components made from materials like Ultem, aluminum, stainless steel, and titanium.
Based on the provided information, the Stableloc II External Fixation System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for addressing Colles' fractures and distal radial osteotomies. This is a surgical procedure performed on the human body, not a test performed on samples taken from the body.
- Device Description: The description details an external fixation device and guide pins used to hold bones in place during healing. This is a mechanical device for supporting and stabilizing bone, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information about a patient's health status based on sample analysis
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Stableloc II External Fixation System does not fit this definition.
N/A
Intended Use / Indications for Use
The Stableloc II External Fixation System is used to Colles' fractures and distal radial osteotomies and is not intended for use in the spine.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Stableloc II External Fixation System consists of an external fixation device and a selection of threaded guide pins. The external fixator is not intended for implantation, only as a tool in surgery. It holds in place the pins which provide fracture reduction and alignment. The Stableloc II External Fixator is manufactured from Ultem, aluminum, stainless steel, and titanium while the guide pins are made from stainless steel per ASTM F 138. The external fixator is provided non-sterile. Acumed has identified a set of process parameters for steam sterilization which provide an SAL of 106 as validated by data on file at Acumed. The guide pins are provided sterile. Sterility is achieved by a minimum of 2.5 megarads gamma radiation. Verification of sterility is performed with the AAMI - Method 1. Sterility level is 10th. We make no claims as to the pyrogenicity of this product. Information regarding packaging and labeling has been provided.
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
Colles' fractures and distal radial osteotomies
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.
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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.
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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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§ 888.3040 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.
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Quality Orthopaedic Instruments and Implants
Enclosure D - 510(k) Summary
FEB 1 9 1997
K96SO29
This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 ( FR 807.93.
The Stableloc II External Fixation System consists of an external fixation device and a selection of threaded guide pins. The external fixator is not intended for implantation, only as a tool in surgery. It holds in place the pins which provide fracture reduction and alignment. The Stableloc II External Fixation System is used to address Colles' fractures and distal radial osteotomies and is not intended for use in the spine. The Stableloc II External Fixator is manufactured from Ultem, aluminum, stainless steel, and titanium while the guide pins are made from stainless steel per ASTM F 138. The external fixator is provided non-sterile. Acumed has identified a set of process parameters for steam sterilization which provide an SAL of 106 as validated by data on file at Acumed. The guide pins are provided sterile. Sterility is achieved by a minimum of 2.5 megarads gamına radiation. Verification of sterility is performed with the AAMI - Method 1. Sterility level is 10th. We make no claims as to the pyrogenicity of this product. Information regarding packaging and labeling has been provided.
The Stableloc II External Fixation System is similar to EBI Medical System's Orthofix Dynamic Axial Fixation System in material, intended use, and design. Each system's guide pins are manufactured from stainless steel. Both devices are intended to be used for Colles' fractures and distal radial osteotomies. Both devices are designed to hold two proximal and two distal guide pins and allow the pins to be adjusted. Also, the surgical techniques of both devices are similar. Based on the similarities between the Stableloc II External Fixator and the Orthofix Dynamic Axial Fixator, the safety and effectiveness is expected to be similar to the orthofix Dynamic Axial Fixator.