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510(k) Data Aggregation
K Number
K212941Device Name
Porous Patella
Manufacturer
Encore Medical, L.P. dba DJO Surgical
Date Cleared
2022-01-20
(127 days)
Product Code
MBH, JWH
Regulation Number
888.3565Why did this record match?
Applicant Name (Manufacturer) :
Encore Medical, L.P. dba DJO Surgical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Joint replacement is indicated for patients suffering from disability due to:
· degenerative, post-traumatic or rheumatoid arthritis;
· avascular necrosis of the femoral condyle;
· post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
· moderate valgus, varus or flexion deformities;
· treatment of fractures that are unmanageable using other techniques.
This device may also be indicated in the salvage of previously failed surgical attempts. All devices are intended for cemented applications except for the FOUNDATION® Porous Coated Femur, FOUNDATION® Porous Coated Tibia Stemmed, FK/3DKNEE™ Porous Coated Downsize Tibia, 3DKNEE™ Porous Coated Femur, 3DKNEE™ Porous Coated Tibia, EMPOWR Porous® Knee Femur, EMPOWR Porous® Knee Tibia and Patella - Metal Backed which are intended for cementless applications.
While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.
Device Description
The Porous Patella e+TM is a sterile, single-use, non-modular metal-backed patella that is manufactured from moderately crosslinked UHMWPE blended with Vitamin E and titanium alloy. The device is offered in a symmetric, domed, design available in multiple sizes. The device is intended for cemented or uncemented applications.
Non-sterile surgical instruments are supplied with the implant.
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