(56 days)
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No
The summary describes a mechanical bone screw and does not mention any AI or ML components or functionalities.
No
The device is a bone fixation screw used in orthopedic surgery to provide additional fixation. Its purpose is structural support, not to treat a disease or condition in a therapeutic manner.
No
The device is described as a bone fixation screw, intended for implantation during orthopedic surgery to provide additional fixation. Its function is mechanical support, not diagnosis.
No
The device description clearly describes a physical bone screw, which is a hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes a bone fixation screw intended for direct implantation into bone during orthopedic surgery. It is a physical implant used to provide structural support and fixation.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens taken from the body. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, this bone fixation screw falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This bone fixation screw is intended for human implantation into prepared bone during orthopedic surgery when the surgeon determines the need for additional fixation (example: fixation of acetabular cup in total hip replacement, fracture fixation, tibial tray fixation, etc.). There is a broad spectrum of uses for this device and the specific use should be determined by the surgeon using sound medical judgment.
Product codes
87HWC
Device Description
The Whiteside Biomachanics Cancellous Bone Screw is a self-tapping screw. The head of the screw has a standard (3.5mm) hexagonal socket drive and the underside is radiused (0.172") to fit a ballnose countersunk hole (0.344"). The thread is generally a helical spiral about the screw's longitudinal axis and has a large outer diameter (6.5mm) designed to affix in healthy cancellous bone.
The insertion of the Whiteside Biomechanics Cancellous Bone Screw is similar to most registered bone screws on the market today. After determining the need for additional fixation the surgeon drills a pilot hole, using a depth gauge to determine the proper screw length, and drives the screw into the prepared hole using a socket-driver with a hexagonal head.
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
bone
Indicated Patient Age Range
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Intended User / Care Setting
surgeon
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
0
510(k) Statement
Device:
Classification Name: Classification No .: Common/Usual Name: Proprietary Name:
Screw, Fixation, Bone Class II, 87HWC, 886.3040 Cancallous Bone Screw Whiteside Biomechanics Cancellous Bone Screw
Manufacturer Identification:
Whiteside Biomechanics 12634 Olive Blvd. Creve Coeur, MO 63141
Establishment Registration Number: 1932213
Device Description:
The Whiteside Biomachanics Cancellous Bone Screw is a self-tapping screw. The head of the screw has a standard (3.5mm) hexagonal socket drive and the underside is radiused (0.172") to fit a ballnose countersunk hole (0.344"). The thread is generally a helical spiral about the screw's longitudinal axis and has a large outer diameter (6.5mm) designed to affix in healthy cancellous bone.
The insertion of the Whiteside Biomechanics Cancellous Bone Screw is similar to most registered bone screws on the market today. After determining the need for additional fixation the surgeon drills a pilot hole, using a depth gauge to determine the proper screw length, and drives the screw into the prepared hole using a socket-driver with a hexagonal head.
Intended Use:
This bone fixation screw is intended for human implantation into prepared bone during orthopedic surgery when the surgeon determines the need for additional fixation (example: fixation of acetabular cup in total hip replacement, fracture fixation, tibial tray fixation, etc.). There is a broad spectrum of uses for this device and the specific use should be determined by the surgeon using sound medical judgment.
Additional Information:
This cancellous bone screw is made of wrought titanium 6Al-4V (ASTM F136) and is available in 5mm increments from 15mm. These bone screws will be provided sterile and double pouched. Resterilization of screws upon contamination is not recommended. DO NOT RESTERILIZE.