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Hip Arthroplasty Indications:
· Painful, disabling joint disease of the hip resulting from: noninflammatory degenerative joint disease (including osteoarthritis or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.

• · Revision of previous unsuccessful femoral head replacement, hip arthroplasty or other procedure.
  · Correction of functional deformity
  · Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Additional indication specific to use of Insignia Hip Stems with compatible Howmedica Osteonics Constrained Liners:
· When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.

Additional indication specific to use of Insignia Hip Stems with compatible ADM and MDM Acetabular Components:
· When the stem is to be used with compatible Howmedica Osteonics ADM and MDM Acetabular Components, the device is indicated for Dislocation risks

Insignia Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

The Insignia Hip Stem is a sterile, single-use device that is intended for cementless fixation into a prepared femoral canal for either primary or revision total or hemi hip arthroplasty. The basic design of the Insignia Hip Stem is similar to other commercially distributed hip stems, such as the Accolade II and Omnifit HFx hip stems. The Insignia Hip Stem is manufactured from Ti-6Al-4V ELI alloy, features a collar, commercially pure titanium plasma sprayed proximal surface, and plasma sprayed hydroxyapatite coating.

The Insignia Hip Stem includes 12 sizes ranging from Size 0 through 11. Each stem size is offered in a Standard Offset and a High Offset option at a single 132 degree neck angle. The stem is designed only for use with compatible V40 Howmedica Osteonics femoral heads, sleeves, and cemented or uncemented acetabular components.

This is a medical device submission for the Insignia Hip Stem, which is a physical implant, not a software device or AI algorithm. Therefore, the questions regarding acceptance criteria and studies related to AI or algorithm performance are not applicable to the provided text.

The document discusses the mechanical and material performance of the hip stem rather than the diagnostic or predictive performance of an AI system. No information about AI acceptance criteria, training sets, test sets, expert adjudication, or MRMC studies for AI devices is present in the provided text.

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