(363 days)
The Hipstar® hip stem is a single-use device intended for cementless fixation within the prepared femoral canal.
The Hipstar® Hip Stem is intended for use in total and hemi hip arthroplasty for the following indications:
- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- rheumatoid arthritis (excepting the Osteolock" HA Acetabular Cup and Peri-. Apatite coated prosteses);
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and,
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
When mated with a constrained acctabular liner the Hipstar® Hip Stern is indicated for use in primary and revision total hip arthroplasty for patients at high risk of hip dislocation due to a history of prior dislocations, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.
The Hipstar® Hip Stem is intended for cementless use only.
The Hipstar® Femoral Stem is a straight hip stem manufactured from titanium alloy, TMZFTM. The Hipstar® hip features a proximal, lateral flare for rotational stability, with a narrow distal stem for implant stability. The body of the stem, with the exception of the trunnion, neck and distal tip, is iron grit blasted for increased bone to implant interface.
The provided text is a 510(k) Summary for the HIPSTAR Femoral Stem, a medical device. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not a study reporting on the device's performance against specific acceptance criteria.
Therefore, the document does not contain any information regarding acceptance criteria, reported device performance, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.
The text focuses on:
- Device Description: Material, design features.
- Intended Use and Indications: When and how the device should be used.
- Substantial Equivalence: Comparison to a predicate device (Zimmer's Alloclassic™ Zweymueller™ SL/SLL femoral hip stem, K030373) based on intended use, design, and sterilization.
- Regulatory Information: Class II device, product codes, classification names.
In the context of medical device submissions like 510(k), the "acceptance criteria" and "study proving the device meets the acceptance criteria" would typically refer to bench testing, animal studies, or clinical studies demonstrating the safety and effectiveness of the device. However, this specific 510(k) summary primarily establishes substantial equivalence to a predicate device rather than presenting detailed performance study results with acceptance criteria.
Therefore, I cannot populate the requested table and information points as the provided document does not contain this type of data.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.