(69 days)
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No
The document describes a mechanical bone screw and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is a hip screw intended for fixation of cancellous bone in fracture treatment, not for therapy itself.
No
The device is a hip screw intended for fixation of cancellous bone in fractures, not for diagnosing medical conditions.
No
The device description explicitly states it is a "cannulated bone screw," which is a physical 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 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 the device is a "cannulated bone screw" intended for the "fixation of cancellous bone" in various fracture and arthrodesis scenarios. This is a surgical implant used directly on the patient's bone.
- Intended Use: The intended use describes surgical procedures and the treatment of bone fractures, not diagnostic testing of bodily samples.
Therefore, based on the provided information, the Cannulated PLUS™ Hip Screw is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Cannulated PLUS™ Hip Screw (Sterile) is intended to be used in the fixation of cancellous bone, for treatment of conditions such as, but not limited to:
- femoral neck fractures: 1.
-
- arthrodesis of the hip;
-
- femoral condvie fractures:
-
- tibial plateau fractures;
-
- ankle malleolar fractures; or
-
- elbow fractures
Product codes
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Device Description
The Cannulated PLUS™ Hip Screw (Sterile) is a cannulated bone screw. An optional beveled washer is available for use with osteoporotic bone. The device is available in a range of sizes to fit varying anatomical requirements.
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)
Cannulated PLUS™ Hip Screw
Reference Device(s)
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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.
0
K95583ๆ
Image /page/0/Picture/1 description: The image shows the logo for Wright Medical Technology, Inc. The logo consists of a stylized "W" symbol on the left, followed by the word "WRIGHT" in large, bold letters. Below "WRIGHT" is the text "MEDICAL TECHNOLOGY, INC." in a smaller font. The address "5677 AIR LINE ROAD ARLINGTON, TN 38002" and the number "901 937 9971" are printed below the company name.
510(k) SUMMARY
Contact Person: Judy English Date Prepared: December 22, 1995
| Trade Name: | Cannulated PLUS™ Hip Screw (Sterile) |
|---|---|
| Common Name: | Hip Bone Screw |
| Classification: | II |
| Predicate Device: | Cannulated PLUS™ Hip Screw |
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
Description/Intended Use
The Cannulated PLUS™ Hip Screw (Sterile) is a cannulated bone screw. An optional beveled washer is available for use with osteoporotic bone. The device is available in a range of sizes to fit varying anatomical requirements.
The Cannulated PLUS™ Hip Screw (Sterile) is intended to be used in the fixation of cancellous bone, for treatment of conditions such as, but not limited to:
- femoral neck fractures: 1.
-
- arthrodesis of the hip;
-
- femoral condvie fractures:
-
- tibial plateau fractures;
-
- ankle malleolar fractures; or
-
- elbow fractures
Material
The Cannulated PLUS™ Hip Screw (Sterile) is manufactured from stainless steel. The optional washer is also manufactured from stainless steel.