FENNING FEMORAL COMPONENT
Device Facts
| Record ID | K960303 |
|---|---|
| Device Name | FENNING FEMORAL COMPONENT |
| Applicant | Biomet, Inc. |
| Product Code | LPH · Orthopedic |
| Decision Date | Jun 21, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3358 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
Biomet's Fenning Femoral Component is composed of a metallic femoral stem which is designed to articulate with a commercially available acetabular component. The device limits translation and rotation via the geometry of the articulating surface. There is no linkage across the joint.
Device Story
Metallic femoral stem for hip arthroplasty; designed for articulation with commercially available acetabular components. Features 30° conical collar with plasma-sprayed porous coating for biological fixation without bone cement; proximal lateral porous coating promotes tissue ingrowth. Stem geometry tapered to match canal contours; grit-blasted mid-section; smooth, fluted distal section with coronal slot to reduce stiffness. Used by orthopedic surgeons in clinical settings. Provides rotational stability and stress transfer to proximal femur via collar wedging. Eliminates need for trochanter resection; straight design avoids left/right configuration. Benefits include stable fixation and reduced distal stiffness.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Metallic femoral stem; plasma-sprayed porous coating; grit-blasted surface (200 microinches); fluted distal section. Dimensions: 9mm-17mm diameters, 145mm-165mm lengths. Straight, non-linked, semi-constrained design. Biological fixation via tissue ingrowth; no bone cement used.
Indications for Use
Indicated for patients requiring hip joint replacement. Contraindications include conditions where bone quality is insufficient for biological fixation, active infection, or systemic disorders precluding surgery.
Regulatory Classification
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.
Predicate Devices
- PSL Total Hip (BioPro) (K922500)
- Conical Collar Hip (Kirschner) (K854046)
- C₂ Osteocap Hip (Kirschner) (K861450)
Related Devices
- K971824 — REACH FEMORAL HIP COMPONENT · Biomet, Inc. · Dec 4, 1997
- K974294 — ENCORE LINEAR POROUS COATED HIP · Encore Orthopedics, Inc. · Jan 12, 1998
- K042337 — ZIMMER M/L TAPER HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING · Zimmer, Inc. · Nov 4, 2004
- K982367 — REACH HIP COMPONENT · Biomet, Inc. · Aug 24, 1998
- K973675 — NATURAL-HIP POROUS STEM WITH OFFSET · Sulzer Orthopedics, Inc. · Dec 19, 1997
