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K Number
K032950
Device Name
GEM INSET PATELLAR COMPONENT
Manufacturer
KINAMED, INC.
Date Cleared
2003-12-19

(88 days)

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

The Gem™ Inset Patellar Component is intended to articulate with the Gem™ Total Knee femoral component or the KineMatch™ Patello-Femoral Resurfacing Implant. The Gem" Inset Patellar Component is a single use device that is intended for cemented applications on the surgically prepared posterior patella as part of primary or revision knee arthroplasty. The Gem " Inset Patellar Component replaces the patellar articulating surface of the knee joint to simulate the normal function of the knee.

Device Description

Not Found

AI/ML Overview

This FDA 510(k) letter for the Gem™ Inset Patellar Component does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The document is a clearance letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It focuses on regulatory compliance rather than performance studies.

Therefore, I cannot provide the requested information based on the provided text. The document does not describe:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes, data provenance, number of experts, qualifications of experts, or adjudication methods for a test set.
  • Whether MRMC or standalone studies were done, or their results.
  • Type of ground truth used.
  • Sample size for the training set or how its ground truth was established.

§ 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.