(93 days)
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 3DKNEE™ Porous Tibia which are intended for cementless applications.
The EMPOWR POROUS KNEE System is a line extension to the EMPOWR Knee platform (cleared via K143242), to include porous coated femoral and tibial baseplate implants and instruments, which provide surgeons with comprehensive surgical solutions to address a variety of patient demographics and surgeon preferences.
The EMPOWR 3DKNEE Porous Femur has porous coating applied inside of the cement pocket. The added porous coating allows for long term biological fixation of the device. Therefore, this device is indicated for cementless use.
The EMPOWR Porous Tibia also have a porous coating applied to the backside of the baseplate to allow for long term biological fixation of the device. The distal geometry includes 4 peripheral pegs for initial fixation along with a fully webbed keel to provide rotational stability and initial fixation.
This 510(k) premarket notification describes a line extension for a knee implant system, not an AI/ML powered medical device. Therefore, the requested information about acceptance criteria, study details, and AI-specific metrics cannot be extracted from this document.
The document discusses the EMPOWR Porous Knee System, a medical device for knee joint replacement. It details the device's indications for use, its description, and comparison to predicate devices, focusing on design and material changes (addition of porous coating for cementless application). The document also mentions non-clinical mechanical testing and endotoxin assessment but explicitly states "Clinical testing was not required."
Therefore, the requested tables and information regarding acceptance criteria and studies for an AI/ML device cannot be provided based on the given text.
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.