FOUNDATION FORGED, TEXTURED & POROUS STEMS W/BIOLOX CERAMIC HEADS
Device Facts
| Record ID | K955563 |
|---|---|
| Device Name | FOUNDATION FORGED, TEXTURED & POROUS STEMS W/BIOLOX CERAMIC HEADS |
| Applicant | Encore Orthopedics, Inc. |
| Product Code | LPH · Orthopedic |
| Decision Date | Aug 9, 1996 |
| Decision | SN |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3358 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Biolox ceramic heads and Foundation™ Forged, Textured and Porous Stems are intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal.
Device Story
Biolox ceramic femoral head component; used in conjunction with Foundation™ Forged, Textured, and Porous hip stems; intended for total hip arthroplasty; implanted by orthopedic surgeons in hospital setting; replaces natural femoral head/neck damaged by arthritis, necrosis, or fracture; provides articulating surface for hip joint; restores joint function and mobility.
Clinical Evidence
No clinical data provided; substantial equivalence based on design and material characteristics.
Technological Characteristics
Material: Biolox ceramic; component: femoral head; intended for use with Foundation™ hip stems; semi-constrained cemented prosthesis.
Indications for Use
Indicated for patients requiring total hip arthroplasty due to osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, femoral neck fracture, or revision arthroplasty with minimal bone loss.
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
- Biolox heads used with SL-PLUS and SLR-PLUS Stems (K930963)
Reference Devices
- Foundation™ Forged Stems (K952191)
- Foundation™ Textured Stems (K935263)
- Foundation™ Porous Stems (K952297)
