EXETER MESH

K963940 · Howmedica, Inc. · JDJ · Feb 13, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K963940
• Device Name: EXETER MESH
• Applicant: Howmedica, Inc.
• Product Code: JDJ · General, Plastic Surgery
• Decision Date: Feb 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Exeter Mesh is intended to be used to reinforce bone when additional strengthening and support is required. The Exeter Mesh is available in four (4) styles to fit a variety of anatomical requirements. The mesh is intended to be either cemented in place or affixed with screws. Screws are provided that are 3.5mm in diameter and range in length from 10mm to 35mm.

Device Story

Exeter Mesh provides structural reinforcement for bone; used in orthopedic procedures. Device available in four styles; fixed via bone cement or 3.5mm diameter screws (10mm-35mm length). Operated by orthopedic surgeons in clinical/OR settings. Provides mechanical support to bone tissue; aids in stabilization. Benefits patient by reinforcing compromised bone structures.

Technological Characteristics

Acetabular mesh prosthesis; metallic construction; fixed via bone cement or 3.5mm diameter screws. Four styles available to accommodate anatomical variations.

Indications for Use

Indicated for patients requiring bone reinforcement, strengthening, or support during orthopedic procedures.

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

• Howmedica Acetabular mesh (preamendment)
• Osteonics mesh (K925883)
• Intermedics mesh (K890450)

Submission Summary (Full Text)

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FFR 13 1997
K963940

510(k) Summary

Proprietary Name: Exeter Mesh

Common Name: Prosthesis, Hip, Acetabular Mesh

Classification Name and Reference: 21 CFR 878.3300
Prosthesis, Hip, Acetabular Mesh

Proposed Regulatory Class: Class II
Device Product Code: OR(87) JDJ
50(79)

For information contact:
Frank Maas
Manager, Regulatory Affairs
Howmedica Inc.
359 Veterans Boulevard
Rutherford, NJ 07070
Telephone: [phone]
Fax: [phone]
Date Summary Prepared: 9-30-96

The Exeter Mesh is intended to be used to reinforce bone when additional strengthening and support is required. The Exeter Mesh is available in four (4) styles to fit a variety of anatomical requirements. The mesh is intended to be either cemented in place or affixed with screws. Screws are provided that are 3.5mm in diameter and range in length from 10mm to 35mm.

Substantial equivalence of the Exeter Mesh is based on the equivalence in intended use, materials, design, operational principles, and indications and contraindications to Howmedica's Acetabular mesh (preamendment), and mesh marketed by Osteonics (K925883) and Intermedics (K890450).