(71 days)
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No
The device description and intended use describe a purely mechanical implant for reinforcing the acetabulum. There is no mention of software, algorithms, or any functionality that would involve AI or ML.
Yes
The device is intended to reinforce a deficient or weakened medial acetabular wall and prevent the protrusion of an acetabular cup prosthesis, which are therapeutic actions.
No
The device is a medical implant (cage) designed to reinforce the acetabular wall, not to diagnose a condition.
No
The device description clearly describes a physical, metallic implant (a cage) and associated hardware (screws), not a software-only product.
Based on the provided information, the DePuy Protrusio Cage is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The DePuy Protrusio Cage is a physical implant designed to reinforce the acetabular wall during hip replacement or revision surgery. It is surgically implanted into the body and does not interact with or analyze biological specimens.
The description clearly indicates it's a surgical implant used to provide structural support within the body.
N/A
Intended Use / 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.
Product codes
78 JDJ
Device Description
The DePuy Protrusio Cage is a rimmed metal shell with multiple holes 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
medial acetabular wall, acetabulum
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 878.3300 Surgical mesh.
(a)
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.(b)
Classification. Class II.
0
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 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-6A1-4V, 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.