(32 days)
Total hip components are indicated for cemented use only in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
The Synergy Cemented Hip Stems are manufactured from forged cobalt chrome (CoCr) material (ASTM F799) and are designed for use with existing cobalt chrome or ceramic modular femoral heads with a 12/14 taper.
The provided text is a 510(k) summary for the Synergy Cemented Hip Stems. It describes the device, its intended use, and its substantial equivalence to other legally marketed devices. However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
The document states: "Data indicate that the Synergy Cemented Hip Stems are substantially equivalent to legally marketed devices." This implies that the device's performance was compared to predicate devices, but the specifics of those comparative studies (e.g., what metrics were used, what the acceptance criteria were, how many tests were performed, what the results were) are not detailed in this summary.
Therefore, I cannot populate the table or answer the specific questions about performance criteria, study design, or ground truth based on the information provided in this 510(k) summary. These details would typically be found in more extensive testing reports submitted separately to the FDA for review, but not necessarily in the public-facing 510(k) summary.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.