GLOBAL TAPER SPECTRON HIP STEMS

K970351 · Smith & Nephew, Inc., Orthopaedic Div. · JDI · Feb 28, 1997 · Orthopedic

Device Facts

• Record ID: K970351
• Device Name: GLOBAL TAPER SPECTRON HIP STEMS
• Applicant: Smith & Nephew, Inc., Orthopaedic Div.
• Product Code: JDI · Orthopedic
• Decision Date: Feb 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The hip stem components of the GT Spectron are made of metal alloys. 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

Global Taper (GT) Spectron Hip Stems; metal alloy femoral components; used in primary or revision hip arthroplasty; implanted by orthopedic surgeons in hospital setting; provides structural support for hip joint; allows for cemented or cementless fixation; replaces damaged femoral head/neck; restores joint function; facilitates patient rehabilitation.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Metal alloy hip stem components; modular taper design; supports cemented or cementless fixation; single-use device.

Indications for Use

Indicated for primary and revision hip surgery in patients with 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, endoprosthesis, femoral osteotomy, Girdlestone resection, fracture-dislocation, 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).

Submission Summary (Full Text)

{0}

K97039

# Exhibit 5

## Summary of Safety and Effectiveness

FEB 28 1997

Smith & Nephew Orthopaedics

Global Taper Spectron Hip Stem

The Global Taper (GT) Spectron Hip Stems have a new taper.

The hip stem components of the GT Spectron are made of metal alloys. 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.

The devices are for single use. Cementless or cement fixation is available with these devices. The Spectron Hip Stems have the same function as other hip stems designed for cemented and cementless fixation.

Analysis results were acceptable and the components of the GT Spectron Hip should perform as well as other hip stems.

CONFIDENTIAL