(133 days)
Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:
- Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
- . Inflammatory joint disease including rheumatoid arthritis
- . Correction of functional deformity including congenital hip dysplasia
- . Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
- . Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement
Signature Orthopaedics' Origin, Aria, Remedy, TSI, Pegasus, Spartan, World and Encore Hip femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only.
Signature Orthopaedics' Evolve, Cemented TSI (both CoCr and HNSS variants), and Cemented Origin femoral stems and SignaSure Cemented Cups are intended for cemented fixation only.
Signature Orthopaedics' SignaSure Insert is indicated for use with a cementless Signature Orthopaedics' Logical Acetabular Cup to provide dual mobility articulation.
Signature Orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.
Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head and BiPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as: - . Acute femoral head or neck fracture
- Fracture dislocation of the hip
- Avascular necrosis of the femoral head
- Non-union of femoral neck fractures
- . Certain high subcapital and femoral neck fractures in the elderly
- . Degenerative arthritis involving only the femoral head
Signature Orthopaedics' Encore Hip Stem is manufactured from forged titanium alloy (Ti6Al4V) as per ISO 5832-3 and ASTM F136. The Encore Stem is straight and tapered with a rectangular cross-section. The stem has a polished distal tip to reduce fixation leading to proximal stress shielding. It features a titanium and hydroxyapatite plasma spray proximal coating below its resection line.
The provided document is a 510(k) premarket notification letter and summary for a medical device called the "Encore Hip Stem." It concerns the regulatory approval process for a new hip implant. The document does not contain information about software or AI-based devices; therefore, it does not include acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or training set information as requested in the prompt.
The document discusses the substantial equivalence of the Encore Hip Stem to previously cleared predicate devices based on non-clinical performance testing and engineering evaluations. These tests are related to the mechanical properties and design of the physical implant, not the performance of an AI algorithm.
Specifically, the "Performance Testing" section states:
"Non-clinical testing and engineering evaluations were conducted to verify that the performance of the Encore Hip Stem is adequate for anticipated in-vivo use. No animal or clinical testing was required to support substantial equivalence. Non-clinical testing carried out included:
- Range of Motion Testing
- Stem and Neck Fatigue FEA
- Stem and Neck Fatigue Testing
- Rim Impingement Analysis"
Therefore, I cannot provide the requested information from the given text as it pertains to a physical medical device, not an AI or software device.
§ 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.