(88 days)
The ActiveLock Modular Femoral Hip System is intended for primary or revision reconstruction, with or without bone cement, of the femoral portion of severely disabled and/or very painful hip joint, where radiographic evidence of sufficient sound bone is present. Clinical Indications for Use are:
- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- rheumatoid arthritis;
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and,
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
The ActiveLock M Modular Femoral Hip System is a matrix of interchangeable components (STEM, BODY, ACTUATOR, FEMORAL HEAD) that can be locked together to form a single femoral hip prosthesis.
The provided text is a 510(k) summary for the ActiveLock™ Modular Femoral Hip System, which is a medical device for hip replacement. It outlines the device's design, materials, and substantial equivalence to previously marketed devices. However, this document does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria in terms of clinical effectiveness or diagnostic accuracy.
The document focuses on:
- Substantial Equivalence: Comparing the new device's design, materials, and intended use to existing devices (predicates). This is a regulatory pathway for approval, not a clinical performance study.
- Mechanical Characterization and Corrosion Testing: These are mentioned as having been performed to show substantial equivalence to the predicate devices, indicating engineering performance rather than clinical outcome. The document states, "The ActiveLock Modular Hip System has been evaluated by use of the static and fatigue tests. It has been shown to be substantially equivalent to the predicate devices. [...] The components and materials of the ActiveLock™ Modular Hip System have been tested in corrosion. It has been shown that the materials of the system are resistant to corrosion." No specific acceptance criteria or study details (like sample size, methodology, or results) for these tests are provided.
- Intended Use and Indications: These describe what the device is for, not how well it performs clinically.
- FDA Clearance Letter: This letter confirms the FDA's finding of substantial equivalence but explicitly states a limitation regarding claims for HA-coated versions: "You may not label or in any way promote the HA coated versions of these devices for "biological attachment, enhanced clinical or radiographic performance, enhanced fixation and/or long-term stable fixation." The data presented support equivalence with no additional claims over a conventional press-fit hip prosthesis (i.e., mechanical interlock, only)." This indicates that the 510(k) submission did not include data supporting enhanced clinical performance.
Therefore, I cannot provide the requested information about acceptance criteria and a study demonstrating the device meets those criteria because it is not present in the provided 510(k) summary. The document is typical of a 510(k) submission where the primary objective is to demonstrate substantial equivalence to existing devices based on design, materials, and intended use, rather than presenting a detailed clinical performance study with specific 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.