(61 days)
The indications for Biomet's Ascent™ Porous Open Box PS Femoral Component include:
- Painful and disabled knee joint resulting from osteoarthritis, traumatic arthritis, traumatic arthritis, where one or more compartments are involved.
- Correction of varus, valgus or posttraumatic deformity
- Correction of revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
The Ascent™ Porous Open Box PS Femoral Component is a metallic knee femoral component to be used with Biomet's Ascent™ tibial base-plate components. The device also includes distal femoral pegs. The modular pegs are designed to fasten into the existing distal augment holes of the femoral component and act as alignment devices. The device is manufactured of CoCrMo Alloy and is intended for non-cemented use. The components are identical to those cleared in the previous 510(k) submission (K002678) for cemented application.
The provided text is a 510(k) summary for the Ascent™ Porous Open Box PS Femoral Component. It describes the device, its intended use, indications for use, and claims substantial equivalence to previously marketed devices. However, it explicitly states:
"Clinical and Non-Clinical Testing: None provided"
Therefore, there is no information in this document regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
In summary, the document does not contain the information requested in your prompt.
§ 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.