Intended Use: The subject Restoration Modular 115mm Conical Distal Stem is a sterile, single-use device intended for use in total hip arthroplasty.
Indications for Use:
- Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis;
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and,
- Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
- Primary and revision total hip arthroplasty as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press-fit into the proximal femur.
The subject Restoration Modular 115mm Conical Distal Stem is a line extension to the Restoration Modular Hip System. The Restoration Modular Hip System is a modular femoral replacement system comprised of three main components: the Restoration Modular Proximal Femoral Body, the Restoration Modular Distal Stem, and the Locking Bolt. Each of these components feature unique design iterations and are offered in a range of sizes, allowing for independent sizing of the proximal femoral body and the distal stem. The distal stem addresses fixation and stability, and the proximal femoral geometry allows for adjustments to anteversion, height, and offset. The Restoration Modular Hip System is designed to attain fixation and restore hip biomechanics.
The subject device is a sterile, single-use device designed to be press-fit into a prepared femoral canal for either primary or revision total hip arthroplasty and is labeled as MR Conditional. The Restoration Modular 115mm Conical Distal Stem utilizes a male locking taper for mating with one of the compatible Restoration Modular Proximal Femoral Bodies and Locking Bolt.
The furnished document is a 510(k) premarket notification from the FDA, specifically concerning a medical device called "Restoration Modular 115mm Conical Distal Stem." This document focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a study of a novel device's performance against specific acceptance criteria.
Therefore, the document does not contain any information related to:
- Acceptance criteria directly tied to device performance outcomes (e.g., accuracy, sensitivity, specificity) for a new AI/software device. This notification is for a physical orthopedic implant.
- A study that proves the device meets specific performance acceptance criteria in terms of clinical or algorithmic performance. The document focuses on non-clinical testing (fatigue, biocompatibility, shelf-life, MR safety) to demonstrate equivalence in design and material, not on a clinical performance study.
- Sample sizes for test or training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment. These elements are relevant to the evaluation of AI/software as a medical device (SaMD) where performance is measured against clinical outcomes or expert consensus.
In summary, the provided text does not describe the kind of acceptance criteria or performance study typically associated with AI/software medical devices or diagnostic tools. It is a regulatory submission for an orthopedic implant that demonstrates substantial equivalence through engineering analyses and non-clinical testing.
§ 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.