(84 days)
The Natural-Hip Porous Stem with Offset is intended for use in cases of hemi- or total hip replacement for treatment of the following:
- Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- Those patients with failed previous surgery where pain, deformity or dysfunction persists.
- Revision of previously failed hip arthroplasty.
The Natural-Hip Porous Stem with Offset is a straight stem available in both a collared and collarless design. The design of the neck/taper region provides 6-7mm of offset to allow the surgeon to more closely approximate the normal femoral head center in cases where varus deformity may be present. The component is manufactured from forged titanium alloy (Ti-6AL-The proximal surface of the stem employs circumferential CSTi porous 4V. ASTM F620). coating to provide biological fixation which reduces tracks of debris, thereby potentially inhibiting osteolysis. The collared stem employs CSTi porous coating on the inferior surface of the collar to prevent calcar resorption by providing biological fixation and load transfer in cementless applications. The proximal anterior surface of the stem employs anterior angulation or build-up to match the anatomic angulation of a natural femur. The superior portion has a built-in anteversion of nine degrees (90) to match the anatomic anteversion of the femur. Due to this feature, separate left and right components are offered. The distal portion of the stem employs ribs and flutes on the anterior and posterior sides to enhance cortical contact, thereby providing rotational stability to the stem. In addition, the distal portion of the stem has a flared coronal slot which reduces stem stiffness. The slot provides optimal distal fill of the femoral canal for additional rotational stability. A Sulzer 12/14 configured neck trunnion allows for attachment to a metallic, Biolox, or Zirconia femoral head having a Sulzer 12/14 configured bore
This document is a 510(k) summary for a medical device (Sulzer Orthopedics Inc. Natural-Hip Porous Stem with Offset), not a study report. Therefore, it does not contain the detailed information about acceptance criteria and study results you are asking for.
Here's why the requested information cannot be found in the provided text:
-
Acceptance Criteria and Reported Device Performance: This document states the indications for use of the device and identifies predicate devices for substantial equivalence. It does not list specific performance criteria (e.g., strength, durability, wear rates) or provide data on how the Natural-Hip Porous Stem with Offset performed against those criteria. Substantial equivalence for this type of device typically relies on demonstrating that the new device has the same technological characteristics and intended use as legally marketed predicate devices, implying similar performance.
-
Sample Size and Data Provenance: No clinical study data is presented, so there's no mention of sample sizes for test sets or data provenance (country of origin, retrospective/prospective).
-
Number/Qualifications of Experts for Ground Truth: Since no study with a ground truth component is described, there's no information about experts or their qualifications.
-
Adjudication Method: Not applicable as no study requiring adjudication is referenced.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This type of study is relevant for diagnostic devices where human readers interpret results. The Natural-Hip Porous Stem is an orthopedic implant, so MRMC studies are not applicable.
-
Standalone Performance: Not applicable for an orthopedic implant. Standalone performance relates to the accuracy of an algorithm without human intervention, which isn't considered for a physical medical device like a hip stem.
-
Type of Ground Truth Used: Not applicable, as there's no diagnostic study involving ground truth determination.
-
Sample Size for Training Set: No training set is mentioned as this is not a machine learning/AI device.
-
How Ground Truth for Training Set was Established: Not applicable.
In summary, the provided document is a regulatory submission for premarket clearance (510(k)) based on substantial equivalence, not a clinical trial report detailing performance data against specific acceptance criteria. Such a submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often by showing similar design, materials, and intended use, rather than presenting novel performance study data.
§ 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.