(275 days)
When used with the AGC and Maxim Knee Systems, the indications for use of the Titanium Femoral Component include 1)painful and disabled knee joint resulting from osteoarthritis, rheumatiod arthritis, or traumatic arthritis where one or more compartments are involved, 2)failure of a previous joint replacement procedure. 3)correction of varus, valgus or post traumatic deformity, and 4)correction or revision of unsuccessful osteotomy or arthrodesis.
Device designed for use in patients with metal sensitivity.
Standard surgical and rehabilitative procedures are indicated with this device.
This device is a single use implant for use with bone cement
The femoral components of the AGC and Maxim Knee Systems are identical to their Co-Cr-Mo predecessors with the exception of the material used in manufacturing and a limited component availability. The AGC titanium component is available in primary universal components of five different sizes. The Maxim titanium component is available in five sizes of the primary universal component and five sizes of the revision universal component.
The titanium components are all N ion implanted, to Biomet engineering specification 1.4, in order to reduce the wear of both the titanium femoral component and the ultrahigh molecular weight polyethylene (UHMWPE).
The provided document is a 510(k) summary for a medical device, the Titanium Femoral Component, and does not contain information about acceptance criteria or a study proving the device meets said criteria.
Instead, the document focuses on:
- Substantial Equivalence: It asserts that the Titanium Femoral Component is substantially equivalent to other knee components already on the market from various manufacturers, including:
- Maxim Knee System (Biomet, Inc.)
- AGC 2000 Total Knee Prosthesis (Biomet, Inc.)
- MG II Total Knee (Zimmer, Inc.)
- Kinemax Plus Total Knee System (Howmedia, Inc.)
- Genesis Total Knee System (Smith & Nephew Richards, Inc.)
- Device Description: Details the material (titanium, N ion implanted) and available sizes, noting it's similar to predecessors made of Co-Cr-Mo.
- Intended Use: Specifies its use with the AGC and Maxim Knee Systems for conditions like osteoarthritis, rheumatoid arthritis, previous joint replacement failure, and deformity correction, particularly for patients with metal sensitivity and for use with bone cement.
- Potential Risks: Lists general risks associated with joint replacement devices.
- FDA Communication: A letter from the FDA confirming the finding of substantial equivalence, allowing the device to be marketed, with specific limitations regarding its use as a cemented device only.
Therefore, because this is a 510(k) submission based on substantial equivalence to predicate devices rather than a de novo submission requiring clinical performance data against specific acceptance criteria, it does not include the details requested in your prompt. The "acceptance criteria" here are implicitly satisfying the FDA's requirements for substantial equivalence to legally marketed predicate devices.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.