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K Number
K053514
Device Name
TRIATHLON TOTAL KNEE SYSTEM
Manufacturer
STRYKER ORTHOPAEDICS
Date Cleared
2006-01-26

(41 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

General Total Knee Arthroplasty (TKA) Indications

  • Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid ● arthritis or post-traumatic arthritis.
  • Post-traumatic loss of knee joint configuration and function. .
  • Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned ● to adequate function and stability.
  • . Revision of previous unsuccessful uni-knee replacement or other procedure.

Additional Indications for Universal Baseplates and Stem Components:

  • Ligamentous instability requiring implant bearing surface geometries with increased constraint. ●
  • Absent or non-functioning posterior cruciate ligament. .

Indications for Bone Augments:

  • Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.
  • Salvage of previous unsuccessful uni-knee replacement or other surgical procedure, accompanied . by bone loss.

The Triathlon® Total Knee System components are intended for cemented use only.

Device Description

Not Found

AI/ML Overview

The provided text does not contain any information about acceptance criteria or a study proving device performance, as it is an FDA 510(k) clearance letter for the Triathlon® Total Knee System. This letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements. It does not include details on clinical studies, performance metrics, ground truth, or expert involvement for AI/device performance evaluation.

Therefore, I cannot provide the requested table and study details based on the given input.

§ 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.