(29 days)
This femoral stem is for total hip or hemi-hip arthroplasty and is indicated for the following conditions:
• Non-inflammatory degenerative joint disease (NID), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
· Failed previous surgery where pain, deformity, or dysfunction persists.
- · Revision of previously failed hip arthroplasty.
· Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives.
This stem is for uncemented use only.
The Fitmore Hip Stem is a modular femoral stem intended for total or hemi-hip arthroplasty. The curved, uncemented stem and is coated proximally with Titanium Vacuum Plasma Sprayed (Ti-VPS) and rough-blasted distally. The 12/14 femoral stem is available in multiple sizes in order to address different patient morphologies.
No changes are being made to the Fitmore Hip Stems themselves, a line extension to the rasps provided to facilitate implantation of the Fitmore Hip Stem is being proposed in this submission.
The rasps that are subject of this submission are intended to prepare the femoral canal for final implantation of the stem. They are made of Stainless Steel and are sized relative to the intended Fitmore Stem implant beginning with the starter rasp and becoming progressively larger in order that the femoral canal created by the rasps is sized appropriately to the pre-operative templated size of stem with the created canal also providing the required femoral stability
This is a 510(k) premarket notification for a medical device called the Fitmore Hip Stem. The document describes the device, its indications for use, and a comparison to a predicate device. It also includes information regarding the regulatory classification and contact details.
However, the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of performance metrics like accuracy, sensitivity, or specificity. The submission is for a hip stem and a line extension of rasps used for its implantation. The only performance data mentioned are non-clinical "Usability Testing" and "Similar Device Analysis." There is no mention of an algorithm, AI, or performance evaluated against ground truth.
Therefore, I cannot provide the requested information. The document explicitly states:
- "Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device."
This indicates that the submission relies on substantial equivalence to a predicate device, and the changes involve a line extension (new rasp variants) rather than a significantly different technological element requiring extensive performance studies as you've described.
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.