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K Number
K053417
Device Name
M-COR HIP REPLACEMENT SYSTEM
Manufacturer
PORTLAND ORTHOPAEDICS PTY. LTD.
Date Cleared
2006-07-20

(224 days)

Product Code
LPH,KWY,LZO
Regulation Number
888.3358
Type
Traditional
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The M-COR Modular Hip System has the following indications for use:

  • · The patient should be skeletally mature.
  • · The patient's condition should be due to one or more of the following:
    • Osteoarthritis. 1.
      1. Rheumatoid arthritis.
      1. Ankylosing spondylitis
      1. Psoriatic arthritis.
      1. Tumor conditions involving the upper third of the femur or of the acetabulum
    • Old osteomyelitis with a long infection-free period and a normal WBC, ESR 6. and C-reactive protein.
      1. Non-union of femoral neck fracture or avascular necrosis of the femoral head.
      1. Post-traumatic fracture/dislocation of the hip.
    • Revision of an unsuccessful arthrodesis with either poor positioning or pain in 9. the hip, or where low back pain or knee pain is becoming disabling.
      1. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present.
      1. Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.
Device Description

The M-COR (Modular – Center of Rotation) Hip Replacement System is a modular femoral neck and stem component system, to be used for cementless applications.

The M-COR Hip Replacement System is comprised of two units: the first is a Commercially Pure Titanium (CPT) coated femoral stem component manufactured from titanium alloy (Ti-6Al-4V). The second is a femoral neck component from either titanium alloy (Ti-6Al-4V) or cobalt-chrome.

AI/ML Overview

The provided text describes a 510(k) summary for the M-COR Modular Hip System. This document focuses on demonstrating substantial equivalence to predicate devices through design, material, and manufacturing similarities, supported by analytical and mechanical testing. It does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way typically associated with AI/ML device evaluations.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be extracted:

  • 1. A table of acceptance criteria and the reported device performance: This information is not present. The document mentions "analytical and mechanical testing" and "compliance to standards" but no specific acceptance criteria or performance metrics are detailed.
  • 2. Sample sized used for the test set and the data provenance: Not applicable in this context. The testing is mechanical/analytical, not based on a "test set" of patient data.
  • 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data is not a component of this submission.
  • 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
  • 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a hip replacement system, not an AI/ML diagnostic tool.
  • 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
  • 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a mechanical device. The "ground truth" for a hip implant would be its physical properties and mechanical performance against established standards, not clinical outcomes in the same vein as diagnostic algorithms.
  • 8. The sample size for the training set: Not applicable. No "training set" in the AI/ML sense is mentioned.
  • 9. How the ground truth for the training set was established: Not applicable.

What is present and relevant to a traditional medical device submission:

The document states that the M-COR Modular Hip System underwent:

  • Analytical and mechanical testing to demonstrate substantial equivalence and compliance to standards.
  • The comparison was against predicate devices: S-ROM Femoral Hip Stem, the Apex Modular Hip, and the Margron Hip Replacement.
  • The basis for substantial equivalence was similarities of design, intended use, material, and manufacturing methods.
  • The conclusion was that "differences in the M-COR Modular Hip System™ do not raise any new issues of safety and effectiveness."

§ 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.