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K Number
K042992
Device Name
CORAIL AMT HIP PROSTHESIS
Manufacturer
DEPUY ORTHOPAEDICS, INC.
Date Cleared
2005-02-11

(102 days)

Product Code
LZO,LWJ,MEH
Regulation Number
888.3353
Type
Traditional
Panel
OR
Reference & Predicate Devices
K001991
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:

  • Severely painful and/or disabled joint from 1. osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
  • Avascular necrosis of the femoral head. 2.
  • Acute traumatic fracture of the femoral head 3. or neck.
  • Failed previous hip surgery including joint 4. reconstruction, internal fixation, arthrodesis, hemiarhroplasty, surface replacement arthroplasty, or total hip replacement.
    1. Certain cases of ankylosis.
      The non-porous Corail AMT Hip Stem is indicated for cementless use only.
Device Description

The Corail AMT Hip is a tapered stem available both collarless and collared. This hip stem is manufactured from F-136 titanium (Ti-6Al-4V) and has a layer of hydroxyapatite (HA) coating applied. The Corail AMT Hip is available in standard offset, lateralized high offset and a Coxa vara lateralized offset. The standard offset stems, collared and collarless, are available in 11 sizes (Size 8 to Size 20). The lateralized high offset and the lateralized Coxa vara high offset are available in 8 sizes (Size 9 to Size 16).

AI/ML Overview

The provided text is a 510(k) summary for the Corail AMT™ Hip Prosthesis. It does not contain information about acceptance criteria or a study proving the device meets said criteria.

The document primarily focuses on:

  • Device Description: What the Corail AMT Hip is, its materials, and available sizes.
  • Intended Use and Indications for Use: Why the device is used and the conditions it's designed to treat (e.g., osteoarthritis, avascular necrosis).
  • Substantial Equivalence: A declaration that the Corail AMT Hip is substantially equivalent to previously marketed predicate devices (HA Coating K953111 DePuy Corail® Hip stem and DePuy Titan™ K001991). This is the primary mechanism for clearance for Class II and some Class III devices in the US, rather than proving performance against specific acceptance criteria.
  • Regulatory Classification: Identifying the device as Class II and Class III and the relevant CFR sections.
  • FDA Clearance Letter: Confirming that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

Therefore, I cannot fulfill your request for: Acceptance Criteria, Reported Device Performance, Sample Size, Data Provenance, Number of Experts, Adjudication Method, MRMC study details, Standalone study details, Type of Ground Truth, Training Set Sample Size, or how Training Set Ground Truth was established.

The 510(k) process for this type of device (a hip prosthesis) typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical trials that establish acceptance criteria and performance against them in the way a novel AI or diagnostic device might. The focus is on comparing the new device's technological characteristics, materials, and intended use to those of the predicate device. If they are sufficiently similar, the new device is deemed as safe and effective as the predicate.

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.