(23 days)
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.
Pinnacle® Acetabular Cups are indicated for total hip replacement in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis.
Porous-coated Pinnacle® Acetabular Cups are indicated for cementless application.
The Pinnacle Acetabular System is part of a modular system for use in total hip replacement. The acetabular component is provided as two separate units, a porous coated hemispherical outer shell manufactured from titanium alloy (Ti-6Al-4V) and a liner manufactured from ultra high molecular weight polyetheylene (UHMWPE) or highcarbon cobalt chrome (CrCoMo), both of which lock into the outer shell. The liner component articulates with a femoral head of an appropriate diameter. The subject acetabular cups are coated with a new proprietary titanium porous coating, Gription" ".
This document is a 510(k) summary for a medical device called "DePuy Pinnacle® with Gription™ Acetabular Cups." It is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study proving the device meets specific acceptance criteria in the context of clinical performance or AI algorithm validation.
Therefore, the provided text does not contain any information about:
- Acceptance Criteria for Device Performance: The document focuses on regulatory equivalence, not performance metrics.
- Reported Device Performance: No clinical or bench test performance data is presented.
- Study That Proves the Device Meets Acceptance Criteria: There is no study described that would evaluate performance metrics against defined acceptance criteria.
- Sample Size for Test Set: No test sets for performance evaluation are mentioned.
- Data Provenance: Not applicable as there's no performance data.
- Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.
- Standalone Performance Study: Not applicable.
- Type of Ground Truth Used: Not applicable.
- Sample Size for Training Set: Not applicable.
- How Ground Truth for Training Set Was Established: Not applicable.
Instead, the document details:
- Device Description: The DePuy Pinnacle® with Gription™ Acetabular Cups are a modular system for total hip replacement, featuring a titanium alloy outer shell with a new proprietary titanium porous coating (Gription™) and a UHMWPE or high-carbon cobalt chrome liner.
- Indications and Intended Use: The device is indicated for total hip replacement in conditions like osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, acute traumatic fracture, failed previous hip surgery, and certain cases of ankylosis. It's for cementless application, promoting biological tissue ingrowth.
- Basis of Substantial Equivalence: The key argument for FDA clearance is that the new device is substantially equivalent to previously cleared Pinnacle® Acetabular Cups (with Porocoat®) based on identical intended use, indications for use, material, design, sterilization, packaging, and manufacturing method. The primary difference is the new Gription™ porous coating.
- Regulatory Information: Classification as Class II, product code 87 LPH, under regulation 21 CFR 888.3358.
In summary, this document is a regulatory submission for device clearance based on substantial equivalence to existing predicate devices, not a performance study with acceptance criteria.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.