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K Number
K983153
Device Name
NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTS
Manufacturer
SULZER ORTHOPEDICS, INC.
Date Cleared
1998-12-04

(86 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 Natural-Knee II P.S. Condylar Tibial Inserts are intended for use in the following diagnostic indications:

  • Patient conditions, including but not limited to, inflammatory degenerative joint disease (e.g., rheumatoid arthritis) and noninflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis).
  • Correctable valgus-varus deformity and moderate flexion contracture.
  • Those patients with failed previous surgery where pain, deformity, or dysfunction persist.
  • Revision of previously failed knee arthroplasty.
Device Description

The Sulzer Orthopedics P.S. Condylar Tibial Inserts are manufactured from Ultra High Molecular Weight Polyethylene (UHWMPe) conforming to ASTM F648. The Condylar Inserts are asymmetric; therefore they are available in left and right orientations. The inserts are available in three sizes 00/0, 1/2, and 3/4/5) and seven thicknessses (9, 11, 13, 16, 19, 22, and 25). This device is intended for use with the following devices:

  • Natural-Knee® II Constrained Femoral Component. These tibial inserts cannot be used with any other femoral components
  • . Natural-Knee® II Constrained Knee Tibial Baseplate
  • Natural-Knee® II System Tibial Baseplate.
AI/ML Overview

The provided text describes a 510(k) summary for a medical device called the "Natural-Knee II Posterior Stabilized Condylar Insert." This document is a premarket notification to the FDA, asserting substantial equivalence to existing devices, rather than a clinical study evaluating acceptance criteria and device performance.

Therefore, the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) cannot be extracted from the given text.

The document focuses on:

  • Product Description: Materials, sizes, and compatibility with other knee components.
  • Specific Diagnostic Indications: Conditions for which the device is intended.
  • Substantial Equivalence: Claiming similarity to previously approved devices.
  • FDA Communication: The FDA's letter of clearance, outlining limitations and general controls, but not performance testing results.

To answer your questions, a separate document detailing the performance studies conducted for the Natural-Knee II Posterior Stabilized Condylar Insert would be required.

§ 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.