(110 days)
The Trident® II Acetabular System is intended for use in total hip arthroplasty and is intended for either primary or revision Total Hip Arthroplasty.
Indications for Use:
• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
When used with MDM Liners:
• Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
- Dislocation risks
When used with Constrained Liners:
• The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
The Trident II Acetabular Shells are indicated for cementless use only.
The Trident® II Acetabular Shells, 6.5mm Low Profile Hex Screws and Hex Dome Hole Plug are sterile, single-use devices that are intended for cementless fixation into a prepared acetabulum for either primary or revision Total Hip Arthroplasty. The Trident® II Acetabular System is an extension of the Trident System product line and features the same locking mechanism as the current Trident® and Trident® II Tritanium® product lines. The Trident® II Acetabular Shells are intended to be used with existing Trident® polyethylene inserts, Trident Constrained Acetabular Inserts, MDM® liners and both new and existing surgical instruments.
The Trident® II Tritanium® implant consists of a unique configuration of both solid and porous sections that are simultaneously built using a Laser Rapid Manufacturing (LRM) method of additive manufacturing, applying Stryker's proprietary Tritanium® In-Growth Technology. Tritanium® is a novel highly porous titanium material designed for biological fixation. The Trident® II PSL® Clusterhole HA and Trident® II Clusterhole HA Acetabular Shells feature hydroxylapatite coating over a Commercially Pure Titanium plasma sprayed surface for cementless fixation.
This document describes a 510(k) premarket notification for the "Trident® II Acetabular System," a medical device for total hip arthroplasty. The submission asserts substantial equivalence to previously marketed predicate devices, and therefore, clinical testing was not required. The information provided focuses on non-clinical testing.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present acceptance criteria in a table format with corresponding reported performance for each criterion. Instead, it lists a series of non-clinical tests performed, implying that the device "meets the requirements" or was "characterized according to methods" outlined in various ASTM standards and FDA guidance documents.
Here's a partial reconstruction of what could be inferred as acceptance criteria and "device performance" based on the text:
| Acceptance Criteria (Inferred from Test Objective/Guidance) | Reported Device Performance (Implied) |
|---|---|
| Mechanical Stability (Cementless Fixation): | |
| Resist push-out forces (ASTM F1820) | Testing performed. Implied to meet requirements. |
| Resist lever-out forces (ASTM F1820) | Testing performed. Implied to meet requirements. |
| Resist torque-out forces (ASTM F1820) | Testing performed. Implied to meet requirements. |
| Durability/Fatigue: | |
| Withstand acetabular shell fatigue (Acetabular Shell Fatigue Testing) | Testing performed. Implied to meet requirements. |
| Wear/Interface Performance: | |
| Minimal fretting at MDM liner interface (Fretting Evaluation of the MDM liner) | Testing performed. Implied to meet requirements. |
| Material Properties: | |
| Resistance to plastic deformation (Plastic Deformation) | Testing performed. Implied to meet requirements. |
| Material chemistry meets specifications (Material Chemistry) | Testing performed. Implied to meet requirements. |
| Porous surface meets FDA guidance for orthopedic implants with modified metallic surfaces (Characterization of Chemistry, Physical & Mechanical Properties of porous surface) | Established that porous surface meets requirements. |
| Titanium plasma spray characterized per guidance (Characterization of Chemistry, Physical & Mechanical Properties of porous surface) | Characterized according to methods. |
| Biocompatibility/Pyrogenicity: | |
| Endotoxin limit |
§ 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.