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K Number
K183596
Device Name
Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly
Manufacturer
Total Joint Orthopedics, Inc.
Date Cleared
2019-03-29

(98 days)

Product Code
JWH,MBH
Regulation Number
888.3560
Type
Traditional
Panel
OR
Reference & Predicate Devices
K112906,K140942,K150105,K153075,K153310,K162422,K180159
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Klassic® Knee System is intended for prosthetic replacement of the following:

  • Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis and osteoarthritis
  • Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis
  • Patients with failed previous surgery where pain, deformity, or dysfunction persists
  • Correctable varus-valgus deformity and moderate flexion contracture
  • Revision of a previously failed knee arthroplasty
  • Patients who require a total knee replacement.

The Klassic® Knee System is indicated for cemented use only, except for the Klassic Femur, Porous, and the Klassic Tibial Baseplate, Porous, which are indicated for cementless use.

Device Description

The Klassic® Knee System employs prostheses designed to help surgeons restore knee joint biomechanics intra-operatively. The purpose of this 510(k) is to add the posterior stabilizing Klassic® Knee Femur, PS-Post; Klassic Femoral Pegs; and the Klassic® Tibial Insert, PS-Post with Standard Poly; and the Klassic® Tibial Insert, PS-Post with E-Link® Poly; to the Klassic Knee System. The subject femoral and tibial components are available in various sizes and thicknesses to match patient anatomy.

AI/ML Overview

The document provided is a 510(k) premarket notification letter from the FDA to Total Joint Orthopedics, Inc. regarding their Klassic Knee System. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general controls and regulations. While it mentions that "All results met the predetermined acceptance criteria," it does not provide the specific acceptance criteria or the detailed study results that prove the device meets these criteria.

Therefore, I cannot extract the requested information from this document.

Missing Information:

  • Detailed Acceptance Criteria: The document states that "All results met the predetermined acceptance criteria," but it does not list what those criteria are.
  • Specific Device Performance Data: While it mentions types of engineering analysis and testing (e.g., Modular Peg Strength Analysis, Knee Simulator Wear, Tibial Insert Post Fatigue), it does not provide the reported performance values that resulted from these tests.
  • Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set Information): None of this detailed study information is present in the provided FDA letter. This type of information would typically be found in the 510(k) submission summary or a more detailed technical report, not in the FDA's clearance letter itself.

§ 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.