Search Results

Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, 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, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement
5. Certain cases of ankylosis

The Titanium Tri-Lock Hip Stem is porous coated and intended for cementless use in total hip arthroplasty. The femoral hip stem is manufactured from ASTM F-620, forged titanium alloy. Its porous coating is manufactured from commercially pure titanium beads conforming to ASTM F-67. The subject modified hip stem is intended to be used with a modular head (manufactured from Cobalt Chromium alloy or Zirconia ceramic) which locks onto the femoral hip stem. The modular head articulates with an acetabular cup of an appropriate diameter.

Here's an analysis of the provided documents regarding the Titanium Tri-Lock® Hip Stem, focusing on the absence of information related to acceptance criteria and device performance as if it were an AI/software device.

Key Observation: The provided documents (510(k) summary and FDA clearance letter) pertain to a medical device (hip stem), not a software or AI-driven device. As such, the standard information requested for AI/software device evaluations (like acceptance criteria, sample sizes for test/training sets, expert consensus, MRMC studies, etc.) is not applicable and therefore not present in these documents.

Instead, the documents focus on demonstrating substantial equivalence to a predicate device based on manufacturing, materials, design, and intended use for a physical implant.

Based on the provided documents, it is not possible to answer the specific questions related to AI/software device acceptance criteria and study details.

The Titanium Tri-Lock® Hip Stem is a physical medical implant, and its clearance relies on demonstrating substantial equivalence to an already marketed device (Tri-Lock® Hip Stem) based on:

• Identical intended use
• Identical dimensions
• Identical method of manufacture
• Identical design
• Identical sterilization and packaging methods
• Adequate performance in design control activities (which typically involve mechanical testing, wear testing, material characterization, biocompatibility, etc., for implants, not AI performance metrics).
• The only difference is the material (Titanium vs. CoCr).

Therefore, the requested information categories are not present in these documents.

Ask a specific question about this device