(27 days)
The Modular PLUS® Revision Stem is intended for cementless use in fractures of the femur where a long section of bone is damaged and the stem must anchor into the distal half of the femur.
The Modular PLUS Revision stem is a cementless two part modular system that consists of a distal anchorage module and proximal revision module, connected by a multistage tapered coupling, secured by a cylindrical screw.
A total of 96 different anatomically-matched stems can be combined for the left and right hips by using 24 distal and 6 proximal modules.
The Modular PLUS stem system is manufactured from Ti-6Al-4V alloy that conforms to ASTM F136. The surface is grit blasted with corundum to produce a surface roughness of 4-6um.
This document is a 510(k) premarket notification for a medical device and, as such, does not contain information about acceptance criteria or a study proving the device meets said criteria.
The 510(k) summary (Input {0}) and the FDA clearance letter (Input {1} to {3}) are primarily concerned with demonstrating "substantial equivalence" to a predicate device already on the market, rather than presenting efficacy study results against predefined acceptance criteria for the new device.
Therefore, I cannot extract the requested information from the provided text.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.