K Number
K961526
Device Name
PRESS-FIT POROUS SHELL
Date Cleared
1996-09-17

(148 days)

Product Code
Regulation Number
888.3358
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Press-fit Porous Acetabular Component is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck and/or acetabulum have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
Device Description
The metal shell is fabricated from wrought/forged or cast Ti-6A1-4V. The outside surface of the shell is porous coated with commercially pure titanium beads to provide a porous surface for enhanced press-fit fixation. The metal shell is hemispherical in shape and is available with and without screw holes. The screw holes are for the use of 6.5 mm cancellous bone screws for adjunct fixation. The geometry of the screw holes is such that a 12° angulation of the screws is possible. The poly liners are manufactured from ultra high molecular weight polyethylene and are available in a neutral and 10° hooded design. The hooded design is intended for those patients prone to subluxation because of soft tissue laxity.
More Information

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No
The document describes a mechanical implant (acetabular component) and its materials and design features. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.

Yes
The device is described as "intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion" due to various arthritic conditions, which falls under the definition of a therapeutic device.

No

This device is an implantable acetabular component used in hip replacement surgery, not a device designed to diagnose a condition.

No

The device description clearly details physical components made of metal and polyethylene, indicating it is a hardware medical device, not software-only.

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 treatment of patients undergoing total hip arthroplasty due to various conditions affecting the hip joint. This is a surgical procedure performed in vivo (within the living body) to replace a damaged joint.
  • Device Description: The device is a physical implant (acetabular component) made of metal and polyethylene, designed to be surgically implanted into the hip.
  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform any such testing.

Therefore, the Press-fit Porous Acetabular Component is a surgical implant, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The Press-fit Porous Acetabular Component is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck and/or acetabulum have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

Product codes

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Device Description

The metal shell is fabricated from wrought/forged or cast Ti-6A1-4V. The outside surface of the shell is porous coated with commercially pure titanium beads to provide a porous surface for enhanced press-fit fixation.

The metal shell is hemispherical in shape and is available with and without screw holes. The screw holes are for the use of 6.5 mm cancellous bone screws for adjunct fixation. The geometry of the screw holes is such that a 12° angulation of the screws is possible.

The poly liners are manufactured from ultra high molecular weight polyethylene and are available in a neutral and 10° hooded design. The hooded design is intended for those patients prone to subluxation because of soft tissue laxity.

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

Testing on this device included porous coating, tensile and shear strength, and attachment strength of liners to shell. All results are sufficient for in-vivo loading.

Key Metrics

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Predicate Device(s)

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Reference Device(s)

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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

SEP 17 1980

K961526

Summary of Safety and Effectiveness

Encore Orthopedics®. Inc. 8900 Shoal Creek Blvd. Suite 300 Austin, TX 78757 512-206-1437 Ashley M. Bock

Trade Name: Foundation® Porous Press-fit Acetabular Component

Common Name: Press-fit Porous Shell

Classification Name: Hip joint metal/polymer semi-constrained non-cemented prosthesis

Description: The metal shell is fabricated from wrought/forged or cast Ti-6A1-4V. The outside surface of the shell is porous coated with commercially pure titanium beads to provide a porous surface for enhanced press-fit fixation.

The metal shell is hemispherical in shape and is available with and without screw holes. The screw holes are for the use of 6.5 mm cancellous bone screws for adjunct fixation. The geometry of the screw holes is such that a 12° angulation of the screws is possible.

The poly liners are manufactured from ultra high molecular weight polyethylene and are available in a neutral and 10° hooded design. The hooded design is intended for those patients prone to subluxation because of soft tissue laxity.

Intended Use: The Press-fit Porous Acetabular Component is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck and/or acetabulum have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

Comparable Features to Predicate Device(s): The spherical shape, titanium substrate and beaded coating, indexability of liners in shell and bone screw holes are features that are comparable to other devices in commercial distribution.

Test Results: Testing on this device included porous coating, tensile and shear strength, and attachment strength of liners to shell. All results are sufficient for in-vivo loading.