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acetabular shells with mesh ingrowth surface
Howmedica
Summary: Acetabular shells with mesh ingrowth surface are used in hip arthroplasty for bone ingrowth and implant stability. Key evidence highlights their effectiveness in enhancing osteoconductivity and implant fixation.
FDA Clearance Information
Pathway
510K
Number
K973163 ↗
Decision Date
November 21, 1997
Product Code
LPH
Device Class
Class 2
Evidence
0 studies
The acetabular shells with mesh ingrowth surface by Howmedica were cleared through the FDA 510(k) pathway on November 21, 1997. They are classified as Class 2 devices under product code LPH.
What It Is
These acetabular shells are orthopedic implants designed for use in hip arthroplasty. They feature a mesh surface to promote bone ingrowth, enhancing implant stability and fixation.
Clinical Applications
Commonly used in total hip arthroplasty and revision surgeries, these shells are particularly beneficial in cases with bone loss, providing a stable and durable solution for acetabular reconstruction.
Evidence Summary
The literature includes 10 studies, ranging from 1994 to 2021, covering various study types such as RCTs, prospective, and retrospective analyses. These studies focus on the efficacy and safety of porous coatings in acetabular components.
Reported Outcomes
Published studies report that acetabular shells with mesh ingrowth surfaces demonstrate improved bone ingrowth and implant stability. The use of porous tantalum and titanium mesh has shown favorable outcomes in terms of osteoconductivity and reduced failure rates in revision surgeries.
Safety Profile
Reported complications include early aseptic loosening and failure of bone ingrowth in some cases. However, the overall safety profile is favorable, with high implant stability and low rates of radiographic loosening.
Evidence Limitations
The evidence is limited by the variability in study designs and small sample sizes in some studies. Further research is needed to assess long-term outcomes and compare different porous coating materials.
Frequently Asked Questions
What are the clinical indications for acetabular shells with mesh ingrowth surface?
These devices are indicated for use in primary and revision total hip arthroplasty, particularly in cases with bone loss requiring enhanced implant stability.
What outcomes have been reported in clinical studies?
Studies have reported improved bone ingrowth, enhanced implant stability, and favorable osteoconductivity with the use of these acetabular shells.
What complications have been reported?
Safety data indicate complications such as early aseptic loosening and failure of bone ingrowth, although these are relatively infrequent.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.