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K Number
K234011
Device Name
AMF TT Cones
Manufacturer
LimaCorporate S.p.A
Date Cleared
2024-01-18

(30 days)

Product Code
JWH,MBH
Regulation Number
888.3560
Type
Special
Panel
OR
Reference & Predicate Devices
K230169,K200653
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

AMF TT Cones are intended for use in skeletally mature patients with bone defect or poor bone quality (osteoporotic bone) or in case of sclerotic bone that requires supplemental metaphyseal fixation in the clinical judgment of the surgeon. Tibial and femoral cones are intended for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement.

Device Description

The AMF TT Cones are intended to be used as an optional accessory component in total knee arthroplasty. The AMF TT Cones are one-piece devices, made from Ti6A14V alloy, conically shaped with cannulation all the way through the cone.

With this 510(k) submission, the compatibility of the AMF Revision TT Cones (K200653) with the EMPOWR Revision Knee (K230169) manufactured by Encore Medical, L.P. is introduced.

AI/ML Overview

I am sorry, but the provided text does not contain information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or multi-reader multi-case studies for a device.

The document is a 510(k) premarket notification letter from the FDA to LimaCorporate S.p.A. concerning the AMF TT Cones. It confirms the substantial equivalence of the device to a legally marketed predicate device.

The key points from the provided text are:

  • Device: AMF TT Cones
  • Purpose of filing: Introducing compatibility of the AMF Revision TT Cones (K200653) with the EMPOWR Revision Knee (K230169).
  • Substantial Equivalence: The FDA found the device substantially equivalent to its predicate.
  • Non-clinical testing: The document states that the new compatibility does not introduce a worst-case for mechanical testing and that test results of mechanical testing submitted in K200653 are applicable. It explicitly says, "Additional testing to demonstrate substantial equivalence to predicate devices is thus not required."
  • Clinical testing: The document explicitly states, "Clinical testing was not necessary to demonstrate substantial equivalence of the new AMF TT Cones to the predicate device."

Therefore, without any clinical or non-clinical studies conducted specifically for this 510(k) submission to demonstrate new performance criteria, I cannot fulfill your request for:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication method.
  5. MRMC comparative effectiveness study results.
  6. Standalone performance details.
  7. Type of ground truth used.
  8. Training set sample size.
  9. Ground truth establishment for the training set.

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.