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K Number
K181366
Device Name
REDAPT Porous Acetabular Shell
Manufacturer
Smith & Nephew, Inc.
Date Cleared
2018-09-24

(124 days)

Product Code
LPH,JDI,KWY,KWZ,LZO,OQG
Regulation Number
888.3358
Type
Traditional
Panel
OR
Reference & Predicate Devices
K150790,K110135,K150522,K072121
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis.
  • Fracture or avascular necrosis of the femoral head
  • Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement
  • All forms of osteoarthritis
  • Patients with hips at risk of dislocation
  • Femoral neck fracture or proximal fracture to hip joint

The REDAPT Porous Acetabular Shell for use with the POLACUP Dual Mobility System is intended for single use only and is to be implanted without bone cement. The POLARCUP Dual Mobility System is to be implanted in the REDAPT Porous Acetabular Shell with bone cement.

Device Description

The REDAPT Porous Acetabular Shell is designed for cementless use on the boneinterfacing surface and is made from titanium alloy (Ti-6Al-4V) powder through an additive manufacturing process. The device design allows for the cementing of liners into the shell and incorporates screw holes for fixation.

The POLARCUP Dual Mobility System consists of a metal shell and plastic liner (or insert). POLARCUP Shell is made from Stainless Steel. The inside of the metal shell is polished, and the outside of the plastic liner is able to articulate against this polished surface. The POLARCUP™ Dual Mobility System is an acetabular hip cup prosthesis.

The subject device consists of a REDAPT Porous Acetabular Shell for use with the POLACUP Dual Mobility System. The REDAPT Porous Acetabular Shell is intended to be implanted without bone cement. The POLARCUP Dual Mobility System is to be implanted in the REDAPT Porous Acetabular Shell with bone cement.

The purpose of this 510(k) submission is to modify the indications for the REDAPT Porous Acetabular Shell to allow for a dual mobility use when used with the POLARCUP Dual Mobility System.

AI/ML Overview

This is a premarket notification for a medical device (hip implant components), not an AI/ML powered device. As such, the information requested regarding acceptance criteria, study details, expert involvement, and ground truth for AI/ML models is not applicable to this document.

The document discusses the substantial equivalence of the REDAPT Porous Acetabular Shell with the POLARCUP Dual Mobility System to existing predicate devices based on:

  • Technological Characteristics: The subject device components are stated to be identical to previously cleared devices. The assessment focused on the compatibility of the two systems.
  • Biocompatibility: An evaluation was conducted according to FDA Draft Guidance and ISO-10993 for permanent implants.
  • Mechanical Testing: Non-clinical bench testing was performed.

Here's a summary of the requested information that can be extracted from the document, with an emphasis on why other points are not applicable:

  1. A table of acceptance criteria and the reported device performance:

    Test TypeAcceptance CriteriaReported Device Performance
    Bacterial Endotoxin TestingMet acceptable endotoxin limits as stated in FDA Guidance and ANSI/AAMI ST72. (Implicit)Met the acceptable endotoxin limits.
    BiocompatibilityAdherence to FDA Draft Guidance and ISO-10993 (Implicit - for permanent implants, >30 days)Evaluation completed, summary rationale provided.
    Mechanical TestingPre-determined acceptance criteria (Specific criteria not detailed in the document)Met the acceptance criteria for all outputs. The proposed devices are substantially equivalent to the predicate.

  2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

    • Sample Size: Not specified in the document for any of the tests.
    • Data Provenance: Not applicable. The tests are non-clinical bench and biocompatibility evaluations, not human data studies.

  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

    • Not applicable. This is not an AI/ML powered device requiring expert-established ground truth.

  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

    • Not applicable. This is not an AI/ML powered device requiring adjudication.

  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:

    • No. Not applicable, as this is not an AI/ML powered device.

  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    • No. Not applicable, as this is not an AI/ML powered device.

  7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

    • Not applicable. For this type of device, "ground truth" is typically defined by engineering specifications, material standards (ASTM, ISO), and established testing protocols for mechanical and biocompatibility performance.

  8. The sample size for the training set:

    • Not applicable. This is not an AI/ML powered device.

  9. How the ground truth for the training set was established:

    • Not applicable. This is not an AI/ML powered device.

§ 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.