(85 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, 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, NEO-T, Remedy and Pegasus femoral stems, and Logical acetabular cups are intended for cementless fixation only. Signature Orthopaedics' Evolve 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 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 Origin Coxa Vara Hip Stem is manufactured from titanium alloy per ASTM F136 and below the resection line is coated with HA per ISO 13779-2. The stem is straight and tapered with a lateral chamfer to aid insertion. The stem has both vertical and horizontal grooves to resist axial and torsional loading. The stem has a collar and a shallower neck angle suitable for coxa vara patients.
This document is a 510(k) premarket notification for a medical device, the Origin Coxa Vara Hip Stem. It details the device's indications for use and claims substantial equivalence to previously cleared devices. However, this document does not contain acceptance criteria, device performance data from a clinical study, or information about a study proving the device meets acceptance criteria.
The document discusses "Performance Testing" which refers to non-clinical testing and engineering evaluations, not human clinical studies. Specifically, it mentions:
- Femoral stem and neck fatigue testing: This is a mechanical test conducted on the device itself, not on human subjects.
- Engineering evaluation: This concluded that the Origin Coxa Vara Hip Stem presents a "greater challenge" to fatigue testing than a previously tested device, implying it was robust.
- Omitted testing: Other tests like range of motion analysis, modular component connection strength testing, and coating characterization were omitted because the engineering evaluation determined the Coxa Vara Stem falls within the scope of testing for a previous device.
Therefore, I cannot provide the requested information from this document. The sections you asked for, such as "acceptance criteria," "reported device performance," "sample size for the test set," "data provenance," "number of experts," "adjudication method," "multi-reader multi-case study," "standalone performance," "type of ground truth," "sample size for the training set," and "how ground truth for the training set was established," are all applicable to clinical studies involving real-world data and human subjects, which are not detailed in this 510(k).
§ 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.