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510(k) Data Aggregation
K Number
K230441Device Name
EMPOWR Stem Extender, 50mm
Manufacturer
Encore Medical, L.P DBA Enovis
Date Cleared
2023-03-17
(24 days)
Product Code
JWH
Regulation Number
888.3560Why did this record match?
Applicant Name (Manufacturer) :
Encore Medical, L.P DBA Enovis
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 3DKNEE™ Porous Coated Femur, EMPOWR 3DKNEE™ POROUS Femur, 3DKNEE™ Porous Coated Tibia, and EMPOWR POROUS Tibia 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 EMPOWR Stem Extender, 50mm implant is a modular accessory of the EMPOWR Revision Knee (K213793). When coupled with the EMPOWR Revision Knee, the Stem Extender is intended to be fixed to the bone by cement. The extender is connected to the mating implant, Revision Femur, by 7/16-20 UNF-2A male threaded connection on the implant, and 7/16-20 UNF-2B female threaded connection on the other side that is used to "extend" the length of cemented stem accessories (K173723) in an identical way as the EMPOWR Stem Extender, 25mm (K213793).
The Stem Extender is also compatible with the EMPOWR Universal Tibial Baseplate (K173723) and will be offered for use as an accessory with the baseplate.
The EMPOWR Stem 50mm Extender comes in a single diameter of 15mm and is offered a length of 50mm (Refer to Figure 1). The EMPOWR Stem Extender, 50mm is made of wrought CoCr alloy per ASTM F1537, which is identical to the material used in the 25mm extender included in the EMPOWR Revision Knee (K213793).
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