K Number
K971018
Device Name
SMC ACETABULAR COMPONENT
Date Cleared
1997-10-24

(218 days)

Product Code
Regulation Number
888.3358
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Osteoarthritis Rheumatoid Arthritis Traumatic Arthritis Where the use of a more conservative procedure has failed or is unacceptable
Device Description
The Signal Medical Corporation Acetabular Component is manufactured of forged titanium, 6 aluminum, 4 vanadium, ELI metal (ASTM F-136, F620). The design is made available in thirteen (13) sizes ranging from 48mm to 72mm. The outside diameter of the cup is coated with a commercially pure titanium sintered beaded surface to enhance either bone ingrowth or cement adherence depending on the choice of the surgeon. Also three circumferentially spaced pins or spikes at 120 degree intervals provide for a primary skeletal fixation and reduce the chance of rotation. The inside assembly of the device and the polyethylene insert are identical to the StelKast Corporation Proform Porous Acetabular Assembly (K950827). The inside diameter system provides a locking ring and three pegs that secure the ultra high molecular weight polyethylene articular surface in place. The acetabular inserts are identical to the StelKast Corporation (K950827) inserts. The ultra high molecular weight polyethylene inserts are secured to the acetabular shell as described above and are designed to accept 28mm femoral heads on their inside diameter.
More Information

No
The device description focuses solely on the material, design, and mechanical features of the acetabular component. There is no mention of software, algorithms, or any capabilities that would suggest the use of AI or ML. The predicate device is also a mechanical implant.

Yes
The device is an orthopedic implant for joint replacement, used in treating conditions like osteoarthritis and rheumatoid arthritis, which are therapeutic interventions.

No

The provided text describes an acetabular component, which is a prosthetic implant used in hip replacement surgery. Its purpose is to treat conditions like osteoarthritis and rheumatoid arthritis by replacing damaged joint structures, not to diagnose them.

No

The device description clearly states it is a physical implant made of titanium with a porous coating and fixation pins, which are hardware components.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for treating osteoarthritis, rheumatoid arthritis, and traumatic arthritis where conservative procedures have failed. This is a therapeutic use, not a diagnostic one.
  • Device Description: The device is an acetabular component (part of a hip replacement). It is a physical implant designed to replace a damaged joint surface.
  • Lack of Diagnostic Function: There is no mention of this device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on in vitro analysis.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used for treatment.

N/A

Intended Use / Indications for Use

    1. Osteoarthritis
    1. Rheumatoid Arthritis
    1. Traumatic Arthritis
      Where the use of a more conservative procedure has failed or is unacceptable.

Product codes

LPH

Device Description

The Signal Medical Corporation Acetabular Component is manufactured of forged titanium, 6 aluminum, 4 vanadium, ELI metal (ASTM F-136, F620). The design is made available in thirteen (13) sizes ranging from 48mm to 72mm. The outside diameter of the cup is coated with a commercially pure titanium sintered beaded surface to enhance either bone ingrowth or cement adherence depending on the choice of the surgeon. Also three circumferentially spaced pins or spikes at 120 degree intervals provide for a primary skeletal fixation and reduce the chance of rotation. The inside assembly of the device and the polyethylene insert are identical to the StelKast Corporation Proform Porous Acetabular Assembly (K950827). The inside diameter system provides a locking ring and three pegs that secure the ultra high molecular weight polyethylene articular surface in place. The acetabular inserts are identical to the StelKast Corporation (K950827) inserts. The ultra high molecular weight polyethylene inserts are secured to the acetabular shell as described above and are designed to accept 28mm femoral heads on their inside diameter.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K950827

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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

OCT 2 4 1997