(233 days)
The Smith & Nephew Patient Matched Hip Stem is indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
The REFLECTION Constrained Liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained Liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.
The Endoprostheses System is indicated for non-inflammatory degenerative joint disease including osteoarthritis, osteonecrosis, avascular necrosis and post traumatic arthritis: rheumatoid arthritis; arthritis secondary to a variety of diseases and anomalies and correction of functional deformity such as congenital hip dysplasia or ankylosing spondylitis; revision procedures where other treatments have failed; and treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement.
The Patient Matched Hip Stem is for uncemented sing
The Patient Matched Hip Stem, hereafter referred to as the PMHS, is an anatomic style stem that has been developed to match the hip anatomy of a particular patient. The hip stem geometry is derived by allowing the surgeon to shape the implant based on an x-ray of the patient's anatomy.
The provided text is a 510(k) Summary for the Smith & Nephew Patient Matched Hip Stem (PMHS). This document outlines the device description, intended use, and claims of substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.
510(k) summaries primarily focus on demonstrating substantial equivalence to pre-existing, legally marketed devices. They generally do not include detailed performance studies with acceptance criteria in the same way a Premarket Approval (PMA) application or a de novo submission would. For devices cleared through the 510(k) pathway, the FDA typically reviews existing data and documentation to ensure the new device is as safe and effective as the predicate, rather than requiring extensive new clinical or performance studies with predefined acceptance criteria.
Therefore, I cannot provide the requested information from the given text.
Specifically, the document does not contain:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set, data provenance, number of experts, adjudication methods, or types of ground truth for a test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study or the effect size of AI improvement.
- Information on a standalone algorithm performance study.
- Sample size for a training set or how ground truth for a training set was established.
The document's purpose is to establish substantial equivalence based on design, intended use, and materials to previously cleared devices, rather than to present novel performance data against specific acceptance criteria.
§ 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.