(10 days)
The indications for the Par 5 Acetabular Component are as follows:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Correction of functional deformity
- Treatment of nonunion, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
- Revision of failed total joint construction or treatment
The Par 5 Acetabular Component is a hemispherical metallic acetabular cup with a hook, flange and/or blade extending from the rim. The shell has six holes for placement of 6.5mm cancellous screws similar to a traditional acetabular component. Additionally, the shell has three counterbores for attachment of the hook and blade components and a mounting flange for attachment of the ilium flange. The shell accepts a standard Ring-loc liner.
The forked ilium flange is available in three sizes: small, medium and large and in left, right and in straight configurations. Screw holes and more of the shell are incorporated into the flange. The flange is malleable and can be shaped by the surgeon in the will on the shell of the shell at the mounting anatomy to provide additional support. The ilium flange is attached to the m flange by the component geometry and screw fasteners.
The malleable hook is placed within one of the counterbores of the shell in a position where it will reside beneath the teardrop of the ishium. The hook is formed to the patient's anatomy by the reside benefit is held to the shell by a screw.
The blade component is intended to enter the ishium bone in a manner similar to a sceve. The she curvature of the blade resembles the curvature of the component is held to the shell curvature of the blade roosmbles the out secondarily, by a screw.
The ilium flange and hook are fabricated from commercially pure (CP) titanium. The cup and blade are fabricated from titanium alloy (Ti-6Al-4) conformances blade are labhoutou from the shell with titanium plasma spray.
The provided text describes a medical device, the Par 5 Acetabular Component, and its indications for use, but it does not contain information about acceptance criteria, device performance metrics, or any studies proving the device meets acceptance criteria.
The document is a "SUMMARY OF SAFETY AND EFFECTIVENESS" for a 510(k) submission to the FDA. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with specific performance metrics and acceptance criteria.
Therefore, I cannot provide the requested information based on the given text. The text primarily details:
- Device Description: What the Par 5 Acetabular Component is made of and how it works.
- Indications for Use: The medical conditions for which the device is intended.
- Potential Risks: General risks associated with total joint replacement.
- FDA Clearance Letter: Confirmation that the FDA has found the device substantially equivalent to a predicate device.
To fulfill your request, I would need a document that describes the design verification and validation testing for this device, which would typically include performance criteria, test methods, results, and acceptance criteria.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.