Search Results

The Echelon Titanium Hip System is indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively, treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

The Echelon Titanium Hip System is intended for single use only and implanted without bone cement.

The body of the Echelon Titanium Hip System femoral stems is similar in shape to the Anthology Hip Stem as previously cleared under premarket notification K052792. The material, porous coating and surface finish of the Echelon Titanium Hip System femoral stems are identical to the Anthology Hip Stem (K052792). The Echelon Titanium Hip System femoral stems are offered in primary and revision options featuring a 10/12 neck taper for use with the 10/12 Taper Femoral Heads.

This 510(k) summary for the SMITH & NEPHEW ECHELON TITANIUM HIP SYSTEM does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria through testing or clinical trials.

Instead, the submission relies on demonstrating substantial equivalence to existing legally marketed predicate devices. This means that the device is deemed safe and effective because it has similar design features, overall indications for use, and material composition to devices already cleared by the FDA.

Therefore, for your request, I must report that the requested information is not present in the provided document.

Here's why and what's typically expected in such a request:

• Acceptance Criteria & Reported Device Performance: This document does not specify any measurable performance metrics (e.g., tensile strength, fatigue life, wear rates, clinical success rates, etc.) that the Echelon Titanium Hip System was tested against to establish "acceptance criteria" for a new, novel device.
• Study That Proves the Device Meets Acceptance Criteria: There is no mention of any study (e.g., in-vitro bench testing, animal studies, human clinical trials) specifically designed to demonstrate the performance of the Echelon Titanium Hip System. The entire basis for clearance is the comparison to predicate devices, implying that the established performance of those predicates effectively "proves" the new device's suitability due to its similarity.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth, Training Set: These are all concepts related to the evaluation of diagnostic algorithms or complex AI systems, or performance studies that involve human interpretation or complex data analysis. For a medical device like a hip implant seeking 510(k) clearance based on substantial equivalence, these types of detailed study methodologies are generally not required or presented in the summary unless there are novel aspects requiring such investigation (e.g., new materials, entirely new design principles, or specific performance claims that deviate from predicates).

Conclusion:

The provided 510(k) summary focuses entirely on establishing substantial equivalence for a hip implant system. It explicitly states: "The substantial equivalence of the Echelon Titanium Hip System is supported by its similarities in design features, overall indications, and material composition to table of legally marketed devices for total hip replacement." It also mentions: "The intended use, design, and materials of the Echelon Titanium Hip System are similar to the legally marketed devices listed above."

Therefore, I cannot extract the requested information from this document. The "study" proving the device meets acceptance criteria, in this context, is the comparison to legally marketed predicate devices.

Ask a specific question about this device