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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 ?
510(k)
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.
FDA-Cleared Indications
- Use as an acetabular component in total hip arthroplasty.
- Use in hip reconstruction when acetabular bone support requires a porous or mesh ingrowth surface.
Clinical Applications
- Primary total hip arthroplasty as the acetabular shell component.
- Revision total hip arthroplasty requiring replacement of the acetabular component.
- Acetabular reconstruction when bone loss limits stable fixation of a standard component.
- Cementless fixation in which bone ingrowth is intended to improve implant stability.
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.
Practical Considerations
- The shell must be selected in a size and configuration that matches the patient’s acetabulum and the compatible liner or bearing components.
- Correct preparation of the acetabulum and stable initial fixation are important for successful bone ingrowth.
- The implant is placed by an orthopedic surgeon using surgical exposure and imaging or direct visualization as appropriate; it is not an endovascular device.
- MRI compatibility depends on the complete implant system, materials, fixation method and MRI conditions. The implant record and manufacturer’s current MRI labeling should be checked before scanning.
- Contraindications and precautions may include active infection, inadequate bone stock, skeletal immaturity, or inability to follow postoperative weight-bearing and rehabilitation instructions.
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.