(168 days)
The indications for use of the total hip replacement prosthesis include: 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, which is unmanageable using other techniques. This stem is intended to be used with cement.
When viewed in the mediolateral plane the Linear™ Hip Stem tapers slightly proximal to distal beginning at the distal border of the plasma spray. Proximal to this point the stem flares approximately 6°. The stem has a rectangular cross-sectional geometry to provide rotational stability. The Linear™ Hip Stem is fabricated from wrought/forged Ti-6Al-4V that conforms to ASTM F136. The outside surface of the stem is plasma sprayed with commercially pure titanium (ASTM F67 grade 2) to provide a roughened surface for enhanced cement fixation. The Linear™ Hip Stem is collarless and has a Morse type taper to receive modular heads. This stem is available with a standard head/stem offset and a lateralized version that provides additional lateralization of the patient's femur without increasing leg length. The stem/neck angle is 135°.
The provided text describes a medical device, the Linear™ Hip Stem, and its regulatory clearance. However, it does not contain information about acceptance criteria for device performance in a clinical study, nor does it present any study data to demonstrate that the device meets such criteria.
The document is a "Summary of Safety and Effectiveness" which typically accompanies a 510(k) submission to the FDA. The "Test Results" section only states: "Laboratory testing of the fatigue stem strength and Morse type taper was conducted." This refers to non-clinical, mechanical testing, not a clinical study involving human patients or ground truth established by experts.
Therefore, I cannot provide the requested information. The document focuses on:
- Device Description: What the hip stem is made of, its shape, and features.
- Intended Use: The medical conditions it is meant to treat.
- Comparable Features to Predicate Device(s): How it is similar to existing, legally marketed hip stems to establish substantial equivalence for 510(k) clearance.
- FDA Clearance Letter: Confirmation of regulatory clearance for "cemented use only."
There is no mention of a clinical study, patient outcomes, expert review of images, or AI performance metrics.
§ 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.