(146 days)
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No
The document describes a mechanical hip implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device, a hip stem component, is intended to rehabilitate damaged hips, treat various joint diseases, and correct deformities due to trauma or other conditions, directly addressing and alleviating a medical condition.
No
The device described is a hip stem system, used for surgical implantation in patients with damaged hips, not for diagnosing medical conditions.
No
The device description explicitly states the device consists of "hip stems and femoral heads made of metal alloys," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is a hip stem component used in surgical procedures to replace damaged hip joints. This is a surgical implant, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a metal alloy hip stem and femoral head, designed for surgical implantation with or without cement. This aligns with the description of a medical device used for treatment, not diagnosis.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body to provide information about a patient's health status, which is the defining characteristic of an IVD.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The hip stem components of the GT Tapered Hip System are made of metal alloys. The components are indicated for cemented and uncemented use for individuals undergoing primary and revision surgery where other treatments or devices have failed for rehabilitating hips damaged as a result of trauma, or noninflammatory degenerative joint disease (NDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Indications also include inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
Product codes
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Device Description
The Global Taper (GT) Tapered Hip System consists of hip stems and femoral heads with a new taper.
The hip stem components of the GT Tapered Hip System are made of metal alloys. The devices are for single use. Cementless or cement fixation is available with these devices. The components of the Tapered Hip System have the same function as other hip systems designed for cemented and cementless fixation.
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
hips, femoral, pelvis
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)
Analysis results were acceptable and the components of the Tapered Hip System should perform as well as other hip systems.
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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§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
K963509
il
Summary of Safety and Effectiveness
Smith & Nephew Orthopaedics
Global Taper Tapered Hip System
The Global Taper (GT) Tapered Hip System consists of hip stems and femoral heads with a new taper.
The hip stem components of the GT Tapered Hip System are made of metal alloys. The components are indicated for cemented and uncemented use for individuals undergoing primary and revision surgery where other treatments or devices have failed for rehabilitating hips damaged as a result of trauma, or noninflammatory degenerative joint disease (NDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Indications also include inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
The devices are for single use. Cementless or cement fixation is available with these devices. The components of the Tapered Hip System have the same function as other hip systems designed for cemented and cementless fixation.
Analysis results were acceptable and the components of the Tapered Hip System should perform as well as other hip systems.