(207 days)
Disposable cement spacer molds with stainless steel reinforcement stems, adaptors and inserts are indicated for use to mold a temporary hemi-hip replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is assembled and inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
The StageOne" Select hemi-hip prosthesis is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.)
Due to the inherent mechanical limitations of the hemi-hip prosthesis material (polymethylmethacrylate/gentamicin), the temporary hemi-hip prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.
Cement Spacer Molds are designed to mold a temporary "spacer" hip implant made of antibiotic impregnated bone cement. The spacers are intended for short-term duration use only, not to exceed 6 months.
The StageOne" Select Cement Spacer Molds are a series of Cement Spacer Molds designed to provide modularity of sizing between the femoral stem and the femoral head connponents. The molds provide various stem sizes and various head sizes that can be mated to provide the best fit for each patient. The cement spacer molds are made of biomedical grade silicone. The metal reinforcements within the cement spacer molds are made of implant grade stainless steel.
The provided document is a 510(k) summary for the StageOne™ Select Cement Spacer Molds for Temporary Hip Replacement. It describes the device, its indications for use, and claims substantial equivalence to legally marketed predicate devices.
However, the document does not contain information regarding clinical studies, acceptance criteria, sample sizes for test or training sets, ground truth establishment, expert qualifications, or MRMC comparative effectiveness studies because no clinical testing was performed or provided as a basis for substantial equivalence for this device.
The relevant section states:
- "Non-Clinical Testing: Cyclic fatigue testing was conducted on the StageOne™ Select components and the predicate StageOne™ components to provide a direct comparison of the subject and predicate components."
- "Clinical Testing: None provided as a basis for substantial equivalence."
Therefore, I cannot provide the requested information in the format of a table or answer the specific questions related to clinical trials, as such details are explicitly stated as not being part of the submission for this particular device. The FDA's determination of substantial equivalence was based on non-clinical testing (cyclic fatigue) and comparison to predicate devices, not on human-in-the-loop performance or standalone algorithm performance.
§ 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.