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510(k) Data Aggregation
K Number
K190402Device Name
Triathlon Total Knee System-Additional Components
Manufacturer
Stryker Orthopaedics (aka Howmedica Osteonics Corp.)
Date Cleared
2019-08-22
(184 days)
Product Code
JWH, MBH
Regulation Number
888.3560Why did this record match?
Applicant Name (Manufacturer) :
Stryker Orthopaedics (aka Howmedica Osteonics Corp.)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indications for Use:
General Total Knee Arthroplasty (TKR) Indications:
· Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), 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 knee replacement or other procedure.
- · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture -management techniques.
The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented use.
The Triathlon® Total Knee System beaded with Per-Apatite components are intended for uncemented use only.
The Triathlon® All Polyethylene tibial components are indicated for cemented use only.
Additional Indications for Posterior Stabilized (PS) and Total Stabilizer (TS) Components:
- · Ligamentous instability requiring implant bearing surface geometries with increased constraint.
- · Absent or non-functioning posterior cruciate ligament.
- · Severe anteroposterior instability of the knee joint.
Additional Indications for Total Stabilizer (TS) Components:
· Severe instability of the knee secondary to compromised collateral ligament integrity or function.
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 total knee replacement or other surgical procedure, accompanied by bone loss.
Additional Indications for Cone Augments:
- Severe degeneration or trauma requiring extensive resection and replacement
- · Femoral and Tibial bone voids
- · Metaphyseal reconstruction
The Triathlon TS Cone Augments are intended for cemented or cementless use.
Device Description
The additional components being added to the Triathlon Total Knee System are:
- Size 0 Cruciate Retaining Femoral Component (cemented use) .
- o Size 0 Primary Cemented Tibial Baseplate
- Size 0 Tritanium Tibial Baseplate for cemented/cementless use ●
- Size 0 CR, CS, and PS Tibial Inserts in X3 ETO and N2Vac ●
- New PS Femoral Component with modified intercondylar PS box (cemented use) ●
- o New PSR (Posterior Stabilizing Rotation ) tibial insert in sizes 0-8 in X3 ETO
Additionally, engineering analyses and finite element analyses were presented to document the range of motion available with the Triathlon Total Knee System.
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