LogoFDA 510(k) Search
K Number
K991428
Device Name
ASCENT KNEE SYSTEM
Manufacturer
BIOMET, INC.
Date Cleared
1999-05-21

(25 days)

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

The indications for use of the Ascent Knee are the same as for other conventional knee prostheses. These include the relief of pain and restoration of motion due to noninflammatory degenerative joint diseases, rheumatoid arthritis, deformities of the knee and revisions of previously failed knee replacements. Standard surgical and rehabilitative procedures are indicted with this device. This device is for use with bone cement

Device Description

The Ascent Knee System has independent Ti-6A1-4V femoral augments which are designed to replace damaged or diseased knee bone. Indications include the relief of pain and restoration of motion due to non-inflammatory degenerative ioint disease, rheumatoid arthritis, deformities of the knee and revisions of previously failed knee replacements. The device is intended for use with bone cement.

AI/ML Overview

I am unable to provide a description of the acceptance criteria nor a study proving that the device meets it. This document is a 510(k) premarket notification approval by the FDA. It states that the "Ascent Knee System" is substantially equivalent to devices marketed prior to May 28, 1976. This type of notification establishes that the device is safe and effective without requiring new clinical studies to prove safety and effectiveness.

Therefore, the document does not contain information about:

  1. Acceptance criteria and reported device performance.
  2. Sample sizes for test sets or data provenance.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study, nor effect size.
  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 focuses on:

  • Device Description: The Ascent Knee System (Ti-6A1-4V femoral augments) designed to replace damaged knee bone.
  • Indications for Use: Relief of pain and restoration of motion due to non-inflammatory degenerative joint disease, rheumatoid arthritis, knee deformities, and revisions of failed knee replacements. Intended for use with bone cement.
  • Potential Risks: Standard risks associated with joint replacement devices (e.g., reaction to bone cement, fracture, infection, loosening, nerve damage).
  • Regulatory Classification: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis (CFR 888.3560), Class II.
  • Substantial Equivalence: The FDA's determination that the Ascent Knee System is substantially equivalent to legally marketed predicate devices.

§ 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.