(79 days)
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Not Found
No
The device description and intended use focus on a physical implant (acetabular component) and do not mention any software, algorithms, or data processing capabilities that would suggest AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as an implant used for reconstruction of the hip joint due to disease, deformity, or trauma, indicating its role in treating or rehabilitating a medical condition.
No
The device is described as an implantable component for hip joint reconstruction, not for diagnosis.
No
The device description clearly states it is a "full hemispherical metallic shell" with "three superiorly places peas or spikes," indicating a physical implant, 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 provided text describes a surgical implant (a Pegged Acetabular Component) that is placed inside the body to reconstruct a hip joint.
- Intended Use: The intended use is for surgical reconstruction of the hip joint, not for testing samples outside the body.
The device is a Class II or Class III medical device (depending on the specific classification by regulatory bodies like the FDA), but it is not an IVD.
N/A
Intended Use / Indications for Use
The Pegged Acetabular Component is intended for use in reconstruction of the hip joint due to disease, deformity of trauma. The device is intended for cemented application for general use and non-cemented application in skeletally mature individuals undergoing primary surgery for rehabilitating hip joints damaged as a result of noninflammatory degenerative joint disease or any of its composite diagnoses. The device is a single use implant.
Product codes
888.3358, 888.3350
Device Description
The Pegged Acetabular Component is a full hemispherical metallic shell. The shell has three superiorly places peas or spikes to provide initial fixation and rotational control. The outer surface of the shell is porous coated. The device is to be used in conjunction with Biomet's Ringloc Acetabular Liners. The device may be used in coniunction with any commercially available femoral component.
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 joint
Indicated Patient Age Range
skeletally mature individuals
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.)
Not Found
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.
Universal® Acetabular Component (Biomet), Mallory-Head® Acetabular Component (Biomet), Reflection™ Porous-Coated Acetabular Component (Richards), PCA® Acetabular Component (Howmedica), Duraloc™ 300 Acetabular Cup System (DePuy)
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
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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
Image /page/0/Picture/0 description: The image shows the logo for Biomet Inc. The logo is in black and white and features a stylized, blocky font. The letters are bold and connected, creating a solid, unified design. A registered trademark symbol is present in the upper right corner of the logo.
APR 3.0 1997 K970501
Summary of Safety and Effectiveness
Biomet. Inc. Sponsor: Airport Industrial Park Warsaw. Indiana 46580
Device Name: Pegged Acetabular Component
Classification Name: Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis (888.3358) and Hip joint metal/polymer semi-constrained cemented prosthesis (888.3350)
Device Description: The Pegged Acetabular Component is a full hemispherical metallic shell. The shell has three superiorly places peas or spikes to provide initial fixation and rotational control. The outer surface of the shell is porous coated. The device is to be used in conjunction with Biomet's Ringloc Acetabular Liners. The device may be used in coniunction with any commercially available femoral component.
Intended Use: The Pegged Acetabular Component is intended for use in reconstruction of the hip joint due to disease, deformity of trauma. The device is intended for cemented application for general use and non-cemented application in skeletally mature individuals undergoing primary surgery for rehabilitating hip joints damaged as a result of noninflammatory degenerative joint disease or any of its composite diagnoses. The device is a single use implant.
Potential Risks: The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:
Reaction to the bone cement Deformity of the ioint Cardiovascular disorders Fracture of the cement Implant loosening/migration Breakdown of porous surface
Blood vessel damage Soft tissue imbalance Delayed wound healing Metal sensitivity Fracture of component Tissue growth failure
Bone fracture Infection Hematoma Dislocation Excessive wear Nerve damage
Substantial Equivalence: The Pegged Acetabular Component is substantially equivalent to almost all acetabular devices on the market in overall design and intended function. Predicate devices include:
Universal® Acetabular Component (Biomet) Mallory-Head® Acetabular Component (Biomet) Reflection™ Porous-Coated Acetabular Component (Richards) PCA® Acetabular Component (Howmedica) Duraloc™ 300 Acetabular Cup System (DePuy)
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