(45 days)
Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as 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 that are unmanageable using other techniques.
The LINEAGE™ Acetabular System consists of metal acetabular shells and UHMWPE acetabular liners.
The LINEAGE™ Acetabular Shell will be available in a hemispherical titanium allov shell with and without a 14° peripheral rim flare. The shells will be coated with commercially pure titanium plasma spray or porous beads.
Design features of the LINEAGE™ Acetabular Shell are summarized below:
· Total hemispherical design
· Hemispherical design with 14° flare
· Coated with CP Ti plasma spray or porous beads
· Solid, quadrant, and multi-hole options
· Threaded apical hole plug
The LINEAGE™ Acetabular Liners will be available with a 0° and 15° overhangs with/without a 4+mm lateralized shift. The Liner's internal geometry will be intended to be used with our existing femoral heads manufactured from cobalt chrome or ceramic with WMT12/14 taper, Orthomet® taper and A-line taper. The LINEAGE™ Liner's external geometry will be designed to accept the LINEAGE™ Acetabular Shells.
Design features of the LINEAGE™ Acetabular Liner are summarized below:
· 360° liner overhang positioning options
· Features an 18° male taper and peripheral ring assembly to lock the liner into the acetabular shell
· The lip of the 15° liner will be machined to 210°
· The inserts will be offered with 0°and 15° overhangs
· The inserts will also be offered with a 4+mm lateralized shift
· Internal diameter will have a 2mm chamfer to minimize impingement.
The thinnest part of any UHMWPE articulating insert will be greater than 4 mm if attached to a metal or ceramic backing.
This document is a 510(k) summary for the LINEAGE™ Acetabular System, which is a medical device. The document states that the device is substantially equivalent to competitive devices previously cleared for market, and its safety and effectiveness are supported by substantial equivalence information, materials data, and testing results. However, the document does not describe acceptance criteria, the specific study that proves the device meets those criteria, or any of the detailed information requested in your prompt.
Here's why and what information is missing:
- 510(k) Summaries: A 510(k) summary is not a full study report. It's a summary provided to the FDA to demonstrate substantial equivalence to a predicate device. It typically focuses on device description, intended use, and a high-level claim of substantial equivalence, often referencing internal testing or comparison to predicate devices without detailing the studies themselves.
- Acceptance Criteria & Performance: The document states the device's intended use and briefly describes its components and design features. It does not provide specific objective acceptance criteria (e.g., "device must achieve X % accuracy," "wear rate must be less than Y mm/year") or report specific performance metrics against such criteria.
- Study Details: There is no mention of a specific "study" in the sense of a clinical trial or a detailed performance validation study with a test set, experts, ground truth, or statistical analysis. The phrase "testing results provided within the Premarket Notification" is a general statement, not a description of a study.
Therefore, I cannot fulfill your request with the provided input. All the categories you asked for (sample size, data provenance, number of experts, adjudication, MRMC, standalone, ground truth type, training set size, training ground truth establishment) are not present in this 510(k) summary.
The primary information available is:
- Device: LINEAGE™ Acetabular System (metal acetabular shells and UHMWPE acetabular liners).
- Intended Use: Total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with various conditions (non-inflammatory degenerative joint disease, inflammatory degenerative joint disease, functional deformity correction, revision procedures, and treatment of certain fractures).
- Claim: Substantial equivalence to previously cleared competitive devices based on intended use, material, type of interface, design features, and "testing results."
- Regulatory Clearance: K002149, cleared by FDA on August 31, 2000.
§ 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.