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510(k) Data Aggregation
K Number
K182251Device Name
EVOLUTION NitrX Medial-Pivot Knee
Manufacturer
MircoPort Orthopedics, Inc.
Date Cleared
2019-05-16
(269 days)
Product Code
JWH, HRY, MBH
Regulation Number
888.3560Why did this record match?
Applicant Name (Manufacturer) :
MircoPort Orthopedics, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EVOLUTION® NitrX™ Medial-Pivot Knee is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
1. Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis
2. Inflammatory degenerative joint disease, including rheumatoid arthritis;
3. Correction of functional deformity
4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
The EVOLUTION® Medial-Pivot Total Knee System Nonporous implants are for cemented use only.
Device Description
The EVOLUTION® NitrX™ Medial-Pivot Knee is a line extension of the EVOLUTION® MP Total Knee System product line. The device is intended to be used as a medial pivot option in total knee arthroplasty (TKA). The subject device is composed of a femoral component to replace the distal surface of the patient's natural femur and a tibial baseplate component to replace the proximal surface of the patient's natural tibia. The design features are summarized below:
- Manufactured from Cobalt Chrome Alloy
- Coated with Titanium Niobium Nitride
- Sizes 1-8, left and right
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