REVISION HIP SYSTEM
Device Facts
| Record ID | K963486 |
|---|---|
| Device Name | REVISION HIP SYSTEM |
| Applicant | Smith & Nephew Richards, Inc. |
| Product Code | JDI · Orthopedic |
| Decision Date | Nov 27, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3350 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The components are indicated for cemented and uncemented use for individuals undergoing primary and revision surgery where other treatments or devices have failed for rehabilitating hips damaged as a result of trauma, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Indications also include inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
Device Story
Revision Hip System stems; single-use orthopedic implants; intended for cemented or uncemented fixation in primary or revision hip arthroplasty. Device replaces damaged hip joint components; restores function in patients with degenerative joint disease, fractures, or trauma. Used by orthopedic surgeons in clinical/OR settings. Clinical benefit: rehabilitation of hip joint function following failure of prior treatments or severe joint damage.
Clinical Evidence
Bench testing only; no clinical data provided.
Technological Characteristics
Single-use hip system stems; designed for cemented or uncemented fixation. Mechanical orthopedic implant.
Indications for Use
Indicated for patients undergoing primary or revision hip surgery due to trauma, noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, pelvic fracture, diastrophic variant), inflammatory degenerative joint disease (rheumatoid arthritis, congenital dysplasia), remote osteomyelitis, nonunion, femoral neck/trochanteric fractures, or deformity correction.
Regulatory Classification
Identification
A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).
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