REFLECTION DUAL DIMENSION SHELL
Device Facts
| Record ID | K960094 |
|---|---|
| Device Name | REFLECTION DUAL DIMENSION SHELL |
| Applicant | Smith & Nephew Richards, Inc. |
| Product Code | MBL · Orthopedic |
| Decision Date | Mar 27, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3358 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The indications for use include cemented or uncemented total hip arthroplasty for rheumatoid arthritis; osteoarthritis; post-traumatic arthritis; avascular necrosis; femoral neck fractures; osteomyelitis; fracture-dislocation of the hip; and unsuccessful cup arthroplasty, endoprosthesis, femoral osteotomy, or girdlestone resection.
Device Story
Acetabular component for total hip arthroplasty; provides prosthetic socket for femoral head. Features modified outer diameter with peripheral rim enhancement for improved press-fit stability. Available in no-hole (apex hole for insertion) or 3-hole configurations for adjunctive screw fixation. Used in orthopedic surgery; implanted by surgeons. Internal geometry and locking mechanism identical to previous Reflection Acetabular Component. Provides stable foundation for hip joint replacement; facilitates patient mobility and pain relief.
Clinical Evidence
Bench testing only. No clinical data provided.
Technological Characteristics
Material: Titanium 6 Aluminum 4 Vanadium Alloy (ISO 5832/III) with C.P. titanium bead coating (ASTM F67). Design: Acetabular shell with peripheral rim enhancement for press-fit. Options: No-hole or 3-hole configurations. Fixation: Press-fit with optional screw fixation.
Indications for Use
Indicated for patients requiring total hip arthroplasty due to rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, avascular necrosis, femoral neck fractures, osteomyelitis, fracture-dislocation of the hip, or failed prior hip procedures (cup arthroplasty, endoprosthesis, femoral osteotomy, or Girdlestone resection).
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
- Reflection Acetabular Component (K960094 - implied predecessor)
- DePuy Duraloc
- Osteonics PSL
Related Devices
- K970394 — OSTEONICS NORMALIZED AD-HA ACETABULAR COMPONENT SYSTEM · Osteonics Corp. · Apr 22, 1997
- K980774 — OSTEONICS GAP-II RESTORATION ACETABULAR SHELLS · Osteonics Corp. · Apr 29, 1998
- K983502 — OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM · Osteonics Corp. · Dec 16, 1998
- K961186 — DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM · Depuy, Inc. · Sep 17, 1996
- K964003 — METAGEN ALL POLY ACETABULAR CUP SYSTEM · Metagen, LLC · Mar 21, 1997
