REFLECTION ACETABULAR REINFORCEMENT RINGS

K962541 · Smith & Nephew Richards, Inc. · JDJ · Sep 17, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K962541
• Device Name: REFLECTION ACETABULAR REINFORCEMENT RINGS
• Applicant: Smith & Nephew Richards, Inc.
• Product Code: JDJ · General, Plastic Surgery
• Decision Date: Sep 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Reflection Acetabular Reinforcement Ring System is indicated as follows: rheumatoid arthritis, avascular necrosis, femoral neck fractures, osteomyelitis, fracture-dislocation of the hip, and unsuccessful cup arthroplasty, endoprosthesis, femoral osteotomy, or girdlestone resection. Indications also include osteoarthritis, traumatic arthritis, slipped capita epiphysis, fused hip, and diastrophic variant. Reflection Acetabular Reinforcement Rings are intended to be used in primary and revision surgeries where the acetabulum has the deficiencies of the acetabular roof, anterior or posterior pillar, medial wall deficiency, and / or protrusion as a result of the indications listed previously. The device is for single use.

Device Story

Acetabular reinforcement ring; addresses acetabular defects; used in primary and revision hip surgeries; provides structural support for acetabular roof, pillars, or medial wall; manufactured from titanium; single-use; implanted by orthopedic surgeons in clinical/OR setting; facilitates stable fixation for acetabular components in compromised bone stock.

Clinical Evidence

No clinical data provided; safety and effectiveness based on long history of use of similar predicate devices.

Technological Characteristics

Material: Titanium. Form factor: Acetabular reinforcement ring in various sizes. Intended for single use.

Indications for Use

Indicated for patients with acetabular defects due to rheumatoid arthritis, avascular necrosis, femoral neck fractures, osteomyelitis, hip fracture-dislocation, failed prior arthroplasty/osteotomy/resection, osteoarthritis, traumatic arthritis, slipped capital epiphysis, fused hip, or diastrophic variant. Used in primary and revision surgeries involving acetabular roof, pillar, medial wall, or protrusion deficiencies.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Predicate Devices

• Trilogy™ Acetabular System - Zimmer
• Porous Ringloc Acetabular System - Biomet
• S-ROM™ Oblong Component - Joint Medical Products Corporation
• MARS® Ringloc Component - Biomet
• Healey Flanged Component - Biomet
• Original M.E. Müller Acetabular Roof Reinforcement Ring - Protek Ltd.
• H.B. Burch- R. Schneider Reinforcement Cage
• R. Ganz Acetabular Roof Reinforcement Ring with Hook - Intermedics
• Gap Acetabular Cup - Osteonics
• Oh-Harris Protrusio Shell - Howmedica

Submission Summary (Full Text)

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K962541
SEP 17 1996

# Summary of Safety and Effectiveness
## Smith & Nephew Orthopaedics Inc.
### Reflection Acetabular Reinforcement Rings

## Substantial Equivalence Information

The Reflection Acetabular Reinforcement Rings System is similar to the following systems:

1. Trilogy™ Acetabular System - Zimmer
2. Porous Ringloc Acetabular System - Biomet
3. S-ROM™ Oblong Component - Joint Medical Products Corporation
4. MARS® Ringloc Component - Biomet
5. Healey Flanged Component - Biomet
6. Original M.E. Müller Acetabular Roof Reinforcement Ring - Protek Ltd.
7. H.B. Burch- R. Schneider Reinforcement Cage
8. R. Ganz Acetabular Roof Reinforcement Ring with Hook - Intermedics
9. Gap Acetabular Cup - Osteonics
10. Oh-Harris Protrusio Shell - Howmedica

All of the devices listed above are similar in design to the Reflection Acetabular Reinforcement Rings System. The safety and effectiveness of the Reflection Acetabular Reinforcement Rings System is based on the long history of use of these devices in the market place.

## Device Description

The Reflection Acetabular Reinforcement Ring is a device intended to address acetabular defects. The rings are manufactured from titanium in a variety of sizes to accommodate the needs of patients.

## Indications for Use

The Reflection Acetabular Reinforcement Ring System is indicated as follows: rheumatoid arthritis, avascular necrosis, femoral neck fractures, osteomyelitis, fracture-dislocation of the hip, and unsuccessful cup arthroplasty, endoprosthesis, femoral osteotomy, or girdlestone resection. Indications also include osteoarthritis, traumatic arthritis, slipped capita epiphysis, fused hip, and diastrophic variant. Reflection Acetabular Reinforcement Rings are intended to be used in primary and revision surgeries where the acetabulum has the deficiencies of the acetabular roof, anterior or posterior pillar, medial wall deficiency, and / or protrusion as a result of the indications listed previously. The device is for single use.

JG06126A