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K Number
K200653
Device Name
AMF Revision TT Cones
Manufacturer
LimaCorporate S.p.A
Date Cleared
2020-05-07

(56 days)

Product Code
JWH,MBH
Regulation Number
888.3560
Type
Traditional
Panel
OR
Reference & Predicate Devices
K141934,K151266,K152008,K053340,K102896,K103517,K143393
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Physica total knee system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

  • · Non-inflammatory degenerative joint disease: including osteoarthritis, or avascular necrosis;
  • · Inflammatory degenerative joint disease including rheumatoid arthritis;
  • · Correction of functional deformity;
  • · Revision procedures where other treatments or devices have failed; and
  • · Treatment of fractures that are unmanageable using other techniques.

In patients with preserved and well functioning collateral ligaments. Physica PS components are also for:

  • · Absent or not-functioning posterior cruciate ligament;
  • · Severe antero-posterior instability of the knee joint

AMF Revision 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 metaphysed fixation in the clinical judgment of the surgeon. Tibial and femoral cones are intended fixation to the bone and are fixed to the femoral and tibial implants using bone cement.

Device Description

The AMF Revision TT Cones are intended to be used as an optional accessory component in Total Knee Arthroplasty in combinations with the Physica tibial plate (K141934, K151266 and K152008) and Physica PS femoral component (K152008). The AMF Revision TT Cones are one-piece devices, conically shaped with cannulation all the way through the cone.

AI/ML Overview

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) premarket notification letter from the FDA to LimaCorporate S.p.A. for a knee joint prosthesis component. It discusses:

  • Device Name: AMF Revision TT Cones
  • Regulation Number and Name: 21 CFR 888.3560, Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis
  • Regulatory Class: Class II
  • Product Codes: JWH, MBH
  • Indications for Use: For use in knee arthroplasty for various conditions, including revision procedures, and specifically for patients with bone defects or poor bone quality requiring supplemental metaphyseal fixation.
  • Predicate Devices: Zimmer Trabecular Metal Knee System Augments and Stryker Triathlon Tritanium Cone Augments.
  • Summary of Technology Comparison: States substantial equivalence in intended use, principles of operation, design, materials, sterility, and fixation methods to predicate devices.
  • Non-clinical testing: Mentions "Fatigue resistance of the Physica System with AMF Revision TT Tibial Cones" tested using an internal protocol derived from ASTM F1800.
  • Clinical testing: Explicitly states, "Clinical testing was not necessary to demonstrate substantial equivalence of the new AMF Revision TT Cones to the predicate devices."

Therefore, there is no information regarding:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes for test sets or data provenance.
  3. Number of experts or their qualifications for establishing ground truth.
  4. Adjudication methods.
  5. MRMC comparative effectiveness studies or effect sizes.
  6. Standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

The document primarily focuses on establishing substantial equivalence based on non-clinical testing and comparison to predicate devices, without the need for clinical studies as described in your request.

§ 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.