(76 days)
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No
The device description and intended use are purely mechanical, describing a screw for fracture fixation. There is no mention of any software, algorithms, or data processing that would indicate AI/ML.
No
The device is an orthopedic implant (lag screws) used to treat bone fractures, which is a structural support device rather than a therapeutic one that delivers treatment to a medical condition.
No
The device is described as an implantable screw used to treat bone fractures, not to diagnose a condition.
No
The device description clearly states it is a physical implantable screw made of stainless steel or titanium alloy, which is a hardware component.
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, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that this device is a "Lag Screw" made of stainless steel or titanium alloy, designed to be implanted in the body to treat bone fractures.
- Intended Use: The intended use is to treat bone fractures in specific anatomical locations (intertrochanteric, subtrochanteric, and basilar neck). This is a surgical intervention, not a diagnostic test performed on a specimen outside the body.
The information provided describes a surgical implant, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
Synthes DHS/DCS One-Step Lag Screws are designed for use with the Dynamic Hip Screw (DHS) Plates and Dynamic Condylar Screw (DCS) Plates. They are intended to treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
Synthes DHS/DCS One-Step Lag Screw has a 12.7 mm or a 14.0 mm thread diameter and is available in various lengths. The DHS/DCS One-Step is manufactured from stainless steel. Additionally, Synthes Ti-DHS/DCS One-Step Lag Screw and DHS/DCS Lag Screws have a 12.7 mm or a 14.0 mm thread diameter and are available in various lengths. The Ti-DHS/DCS One-The DHS/DCS Lag Screw is Step Lag Screw is manufactured from Titanium Alloy. manufactured from stainless steel. Synthes DHS/DCS One-Step Lag Screw will be provided sterile; gamma radiation will be used to sterilize the device.
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): 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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§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. To the right of the word is a registered trademark symbol.
JAN - 9 1997
Attachment V:
Summary of Safety and Effectiveness Information
Synthes (USA) 1690 Russell Road Paoli, PA 19301
Contact: Sheri Musgnung (610) 647-9700 October 1996
Synthes DHS/DCS One-Step Lag Screws are compared to Synthes Ti DHS/DCS Lag Screws and Synthes DHS/DCS Lag Screws.
Synthes DHS/DCS One-Step Lag Screws are designed for use with the Dynamic Hip Screw (DHS) Plates and Dynamic Condylar Screw (DCS) Plates. They are intended to treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed.
Synthes DHS/DCS One-Step Lag Screw has a 12.7 mm or a 14.0 mm thread diameter and is available in various lengths. The DHS/DCS One-Step is manufactured from stainless steel.
Additionally, Synthes Ti-DHS/DCS One-Step Lag Screw and DHS/DCS Lag Screws have a 12.7 mm or a 14.0 mm thread diameter and are available in various lengths. The Ti-DHS/DCS One-The DHS/DCS Lag Screw is Step Lag Screw is manufactured from Titanium Alloy. manufactured from stainless steel.
Synthes DHS/DCS One-Step Lag Screw will be provided sterile; gamma radiation will be used to sterilize the device.
Based upon the information identified above, Synthes DHS/DCS One-Step Lag Screw is equivalent to Synthes Ti-DHS/DCS One-Step Lag Screw and Synthes DHS/DCS Lag Screw.