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K Number
K231526
Device Name
CORAIL Cemented Femoral Stem
Manufacturer
DePuy Ireland UC
Date Cleared
2023-12-19

(207 days)

Product Code
KWY,KWL,LZO
Regulation Number
888.3390
Type
Traditional
Panel
OR
Reference & Predicate Devices
K123991,K220216
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The use of CORAIL Cemented Femoral Stems is indicated in Total and Hemi hip replacements.

Total hip replacement is indicated in the following conditions:

  1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
  2. Avascular necrosis of the femoral head.
  3. Acute traumatic fracture of the femoral head or neck.
  4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
  5. Certain cases of ankylosis.

Partial hip arthroplasty is indicated in the following conditions:

  1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.
  2. Avascular necrosis of the femoral head.
  3. Non-union of femoral neck fractures.
  4. Certain high subcapital and femoral neck fractures in the elderly.
  5. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
  6. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemiarthroplasty.

The DePuy CORAIL Cemented Femoral Stems are indicated only for use with bone cement.

Device Description

The CORAIL Cemented Femoral Stem is manufactured from wrought high nitrogen stainless steel, and is designed to be used as one component of a system of prostheses in hip arthroplasty. The stems are compatible with both unipolar and bipolar femoral heads intended for hemi-hip arthroplasty and with modular metal and ceramic femoral heads intended for total hip arthroplasty. The CORAIL Cemented Femoral Stem implants are uncoated with a polished finish, intended for use with bone cement. The stem consists of a wide range of stem neck designs and sizes allowing an accurate anatomical match for a wide range of patients. The CORAIL Cemented Femoral Stem is designed to provide a cemented version of the primary predicate DePuy CORAIL AMT Hip Prosthesis stem (cleared under 510(k) K123991).

AI/ML Overview

This FDA 510(k) summary describes a new device, the CORAIL Cemented Femoral Stem, and its comparison to predicate devices, but it does not include any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document states:

  • "No clinical tests were conducted to demonstrate substantial equivalence." (Page 10)
  • The non-clinical tests were conducted "to demonstrate its substantial equivalence of safety and effectivenes to the identified predicate devices." (Page 10)

The "acceptance criteria" presented in the document are primarily the technological characteristics of the device being compared to predicate devices to establish substantial equivalence, rather than performance metrics with specific targets. The "study" mentioned consists of a series of non-clinical tests (mechanical, material, sterilization, biocompatibility, etc.) designed to show that the new device is as safe and effective as the predicate devices, not that it meets specific, predefined performance thresholds against a gold standard in a clinical context.

Therefore, I cannot provide the requested information for the following points as they are not present in the provided text:

  1. A table of acceptance criteria and the reported device performance: This detailed information is not included. The document compares features of the new device to predicates as shown in the "SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICES" (pages 6-9), but these are comparisons of design and material, not performance against specific acceptance criteria.
  2. Sample size used for the test set and the data provenance: Not applicable as no clinical study with a test set is described. Non-clinical tests typically use material samples or prototypes, not clinical data.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no clinical test set requiring expert ground truth.
  4. Adjudication method for the test set: Not applicable as there is no clinical test set.
  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 device is a physical hip stem, not an AI diagnostic tool.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical hip stem.
  7. The type of ground truth used: Not applicable as there is no clinical test set requiring ground truth.
  8. The sample size for the training set: Not applicable as there is no machine learning component or training set discussed.
  9. How the ground truth for the training set was established: Not applicable as there is no machine learning component or training set discussed.

Summary of Non-Clinical Tests Conducted (relevant to the "study" aspect as provided):

The document lists the following non-clinical tests to demonstrate substantial equivalence:

  • Distal fatigue and neck fatigue: performed per ISO 7206-4:2010, ISO 7206:2013 and ASTM F2068-3.
  • Range of motion: performed per EN ISO 21535:2009+A1:2016.
  • MRI Safety: performed per ASTM F2503-23, ASTM F2182-19e2, ASTM F2052-21, ASTM F2213-17 and ASTM F2119-07.
  • Biocompatibility testing: performed per EN ISO 10993-1-2018, ISO 10993-3:2014, ISO 1099-5:2009, ISO 1099-6:2016, ISO 1099-10:2010, ISO 10993-11:2017, ISO 10993-12:2012, ISO 10993-18:2020, BS EN ISO 22442-1:2015 and ISO 10993-17:2002.
  • Bacterial endotoxins: performed per ANSI/AAMI ST 72:2019.

The conclusion from these non-clinical tests was that "The CORALL Cemented Femoral Stem is substantialy equivalent to the identified predicates with respect to minded use, indications, materials, geometry, range of sizes, and method of fixation. Results of performance that the CORAL Cemented Femoral Stem performs as well as the predicate devices DePuy CORAIL AMT Hip Prosthesis and C-STEM AMT LE Prosthesis (K123991 and K220216)." (Page 10)

§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.