(326 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 and Pegasus femoral stems and Logical acetabular cups are intended for cementless fixation only. Signature Orthopaedics' Evolve, Cemented TSI (both CoCr and HNSS variants) and Cemented Origin femoral stems are intended for cemented fixation only.
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
The Signature Orthopaedics' SS Cemented TSI Hip Stems are manufactured from High Nitrogen Stainless Steel per ASTM-F1568 and ISO 5832-9. The SS Cemented TSI stem is a highly polished anatomically curved stem with a round cross-section intended for cemented use in total hip arthroplasty. The Cemented TSI Hip Stems are compatible with Signature Orthopaedics' Ceramic Femoral Heads (per K121297).
This document describes the FDA's clearance of the Signature Orthopaedics Cemented TSI Hip Stem (K192024). However, the provided text does not contain details about acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/ML-enabled medical device.
The document primarily focuses on the regulatory clearance process for a traditional medical device (a hip stem), establishing its substantial equivalence to previously cleared predicate devices. The "Performance Testing" section mentions:
- Stem fatigue and neck fatigue testing per ISO 7206-4 and ISO 7206-6.
- Engineering evaluations to verify performance is equal to or better than the predicate device.
- Validation as non-pyrogenic.
These are standard mechanical and biocompatibility tests for orthopedic implants, not performance studies for AI/ML algorithms.
Therefore, I cannot provide the requested information regarding acceptance criteria and the study proving an AI device meets them based on the provided text. The document does not describe an AI/ML-enabled device or its associated performance studies.
§ 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.