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Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.

Hemi hip replacement is indicated in the following conditions:

1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treation.
2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
3. Avascular necrosis of the femoral head.
4. Non-union of femoral neck fractures.
5. Certain high subcapital and femoral neck fractures in the elderly.
6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty

The Summit DuoFix Hip is identical to the previously cleared Titanium Porocoat Hip stem (K170339, K011489, K001911) except for the presence of a thin layer of hydroxyapatite coating applied to the porous coated surface. The Summit DuoFix Hip is a non-modular, collarless, Titanium, tapered, press-fit femoral stem. The hip stem is manufactured from ASTM F-620-87 forged Titanium (Ti-6Al-4V) and has a sintered commercially pure Titanium bead porous coating (Porocoat®) applied to the stem. The porous coating is applied over the circumferential ridges on the proximal region of the stem. A thin coating of hydroxyapatite (HA) is sprayed over the porous coating in a uniform thickness via a plasma spray process. The HA powder used in the plasma spray process conforms to ASTM F1185-88 and ISO 13779-6 Hydroxyapatite (Ca5(PO4)3OH) ceramic. The plasma spray process to apply the HA coating to the Summit DuoFix Stem is the same process used to coat the Pinnacle Duofix Acetabular Cup which was cleared in K192919. The HA material used for the Summit DuoFix Stem is the same as the HA material used on the Pinnacle Duofix Acetabular Cup. The distal portion of the stem has a grit blast surface finish. The hip stem consists of 10 body sizes ranging in diameter from 7 mm to 18 mm with each body size having two offset options. The design is a medially rounded trapezoid with a longitudinal ridge to optimize distal rotational stability. The Summit DuoFix hip stem uses a 12/14 taper for attachment of femoral ball heads. Femoral ball heads are intended to be used with the Summit DuoFix Hip prosthesis to provide the femoral prosthetic articular surface for the total hip arthroplasty. The femoral head articulates with an acetabular cup prosthesis that functions to restore mobility of the hip.

No acceptance criteria or study information for a device that meets such criteria were provided in the document. The document is a 510(k) premarket notification for a hip implant and discusses non-clinical tests conducted to demonstrate substantial equivalence to predicate devices, but does not present acceptance criteria or reported device performance in the format requested.

The provided text focuses on the substantial equivalence of the "Summit DuoFix™ HA Coating" to predicate devices based on non-clinical tests and manufacturing/packaging changes. It explicitly states: "No clinical tests were necessary to clear the current device and thus no clinical testing was conducted here to demonstrate substantial equivalence."

Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, types of ground truth, or details about the training set.

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