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K Number
K200765
Device Name
Genius / Genuin Total Knee System
Manufacturer
Biorad Medisys PVT LTD
Date Cleared
2021-05-05

(407 days)

Product Code
JWH
Regulation Number
888.3560
Type
Traditional
Panel
OR
Reference & Predicate Devices
K182301
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Indicated for use only with bone cement for patients suffering from: Severe knee joint pain, loss of mobility and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, Correction of functional deformities. Posttraumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; Moderate valgus, Varus or flexion trauma. Knee fractures untreatable by other methods.

Device Description

The Genius / Genuin Total Knee System has 3 major components:

  • Femoral component
  • Tibial component - Includes Tibial Tray and Tibial Insert
  • Patellar component
AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Genius / Genuin Total Knee System." It does not contain information on acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML algorithm. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance (mechanical testing and material characterization).

Therefore, I cannot provide the requested information. The document explicitly states:

  • Clinical Performance Data/Information: "Not provided as the device is proven to be substantially equivalent to predicate device."
  • Acceptance Criteria for an AI device: Not present.
  • Study proving device meets acceptance criteria: Not present.

The information provided pertains to the mechanical and material aspects of a knee implant, not an AI or algorithm-driven medical device.

§ 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.