K962007 · Depuy, Inc. · JDJ · Aug 1, 1996 · General, Plastic Surgery
Device Facts
Record ID
K962007
Device Name
PROTRUSION CAGES
Applicant
Depuy, Inc.
Product Code
JDJ · General, Plastic Surgery
Decision Date
Aug 1, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.3300
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The DePuy Protrusio Cage is intended to be used to reinforce a deficient or weakened medial acetabular wall to prevent the protrusion of an acetabular cup prosthesis into the abdominal cavity and may be indicated for use in cases involving acetabular revision procedures, severe osteoporosis, Protrusio Acetabuli, or a shallow acetabular roof.
Device Story
Rimmed metal shell with multiple holes and iliac/ischial wings; used to reinforce deficient medial acetabular wall; transfers stress from medial wall to acetabular rim; fixed to solid bone via titanium screws; acetabular cup prosthesis cemented inside cage; used in orthopedic surgery; improves cup fixation; prevents cup protrusion into abdominal cavity.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Material: Ti-6Al-4V. Form factor: Domed metal shell with iliac and ischial wings. Dimensions: 52, 56, 60mm diameters. Fixation: 6.5mm diameter titanium bone screws (lengths 20-60mm). Energy source: None (mechanical).
Indications for Use
Indicated for patients requiring acetabular reinforcement during revision procedures, severe osteoporosis, Protrusio Acetabuli, or shallow acetabular roof to prevent acetabular cup protrusion.
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
DePuy Protrusio Rings (pre-1976)
Submission Summary (Full Text)
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K962007
AUG - 1 1996
# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
**NAME OF FIRM:** DePuy Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988
**510(K) CONTACT:** Cheryl Hastings
Manager, Clinical Affairs
**TRADE NAME:** DePuy Protrusio Cages
**COMMON NAME:** Surgical Mesh
**CLASSIFICATION:** 878.3300 Surgical Mesh
**DEVICE PRODUCT CODE:** 78 JDJ
**SUBSTANTIALLY EQUIVALENT DEVICES:** DePuy Protrusio Rings
## INTENDED USE AND DEVICE DESCRIPTION:
The DePuy Protrusio Cage is intended to be used to reinforce a deficient or weakened medial acetabular wall to prevent the protrusion of an acetabular cup prosthesis into the abdominal cavity and may be indicated for use in cases involving acetabular revision procedures, severe osteoporosis, Protrusio Acetabuli, or a shallow acetabular roof.
The DePuy Protrusio Cage is a rimmed metal shell with multiple holes and illiac and ischial "wings". It is intended to reinforce weak acetabula by transferring stress away from the medial wall to the stronger acetabular rim. The wings and rim of the cage can be fixed to solid bone using Titanium bone screws. The reinforcement provided by the Protrusio cage allows improved fixation of an acetabular cup prosthesis, which can be fixed inside the Protrusio cage using bone cement. The DePuy Protrusio cage is available in diameters of 52, 56 and 60mm in right and left configurations. The Titanium bone screws have a diameter of 6.5mm and are available in lengths of 20, 25, 30, 35, 40, 45, 50, 55 and 60mm.
## BASIS OF SUBSTANTIAL EQUIVALENCE:
The DePuy Protrusio Cages are similar to the Protrusio Rings that were sold by DePuy prior to 1976. Like the pre-enactment Protrusio Rings, the Protrusio Cages are intended to reinforce weak acetabula. The Protrusio Rings were manufactured from Protasul 10 Co-Ni-Cr-Mo and the design consisted only of a rim with flanges which extended into the acetabulum. The Protrusio Cages are manufactured from Ti-6Al-4V, have more of a domed shell that extends into the acetabulum and have illiac and ischial wings which help fix the cage to the rim of the acetabulum.
