(77 days)
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No
The summary describes a mechanical device for bone fixation and does not mention any software, algorithms, or data processing related to AI/ML.
Yes
The device is used for the fixation of hip fractures, specifically to provide structural support and stability to assist in the healing of bone fractures. This fits the definition of a therapeutic device as it directly treats a medical condition (fracture) by promoting healing and improved function.
No
The device is described as a titanium alloy device for the "fixation of intracapsular and extracapsular (intertrochanteric) fractures of the hip," indicating it is a therapeutic device used in surgical repair, not for diagnosis.
No
The device description clearly states it is a titanium alloy device for fracture fixation, which is a physical hardware component. The submission also describes minor modifications to the design of this physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of hip fractures. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a titanium alloy implant used to stabilize bone fractures. It is physically inserted into the patient.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. This device does not perform any such analysis.
Therefore, the Alta® Dome and Plunger is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Alta® Dome and Plunger, previously cleared by the FDA, is a titanium alloy device for the fixation of intracapsular and extracapsular (intertrochanteric) fractures of the hip. This submission adds an additional indication for the use of this device with bone cement.
Product codes
888.3030
Device Description
The Alta® Dome and Plunger, previously cleared by the FDA, is a titanium alloy device for the fixation of intracapsular and extracapsular (intertrochanteric) fractures of the hip. This submission adds an additional indication for the use of this device with bone cement. A small bolus of doughy bone cement is placed into the dome before it is mounted on the insertion tool. After insertion into the femur, the tool is tightened to extrude the cement into the surrounding cancellous bone. The addition of the bone cement provides enhanced early stability, reduced risk of superior cut-out and the ability to bear higher loads. The submission also describes several minor modification to the design of 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
hip, femur
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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
Howmedica Haig Nail, Zimmer Haig Nail
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
JUN 1 3 1996
K96 1213
510(k) Summary
Proprietary Name: Alta® Dome and Plunger (MEC Hip Bolt)
Common Name: Hip Fracture Fixation Device
Classification Name: Single/Multiple Component Metallic Bone Fixation Appliance and Accessories 888.3030
The Alta® Dome and Plunger, previously cleared by the FDA, is a titanium alloy device for the fixation of intracapsular and extracapsular (intertrochanteric) fractures of the hip. This submission adds an additional indication for the use of this device with bone cement. A small bolus of doughy bone cement is placed into the dome before it is mounted on the insertion tool. After insertion into the femur, the tool is tightened to extrude the cement into the surrounding cancellous bone. The addition of the bone cement provides enhanced early stability, reduced risk of superior cut-out and the ability to bear higher loads. The submission also describes several minor modification to the design of the device.
The substantial equivalence of this device is based on an equivalence to the previously cleared Alta® Dome and Plunger and to the use of other trauma devices for the fixation of femoral fractures with the augmentation of bone cement. Both the Howmedica Haig Nail and the Zimmer Haig Nail are indicated for use with bone cement in the stabilization of femoral fractures.
For information contact: John Dichiara
Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 (201) 507-7386 (201) 507-6870 Fax:
For information contact: John Dichiara Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 (201) 507-7386