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510(k) Data Aggregation
K Number
K203230Device Name
Global Shoulder and Delta CTA systems
Manufacturer
Date Cleared
2021-04-02
(151 days)
Regulation Number
888.3660Why did this record match?
Applicant Name (Manufacturer) :
DePuy lnc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DePuy GLOBAL ADVANTAGE Shoulder Systems is indicated for use in total or hemi-shoulder replacement for the treatment of:
1. A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis;
2. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).
The DePuy GLOBAL ADVANTAGE Shoulder System is also indicated for hemi-shoulder replacement for the treatment of:
1. Ununited humeral head fractures;
2. Avascular necrosis of the humeral head.
The DePuy GLOBAL ADVANTAGE CTA Humeral Heads are indicated only for hemi-shoulder replacement in patients with rotator cuff tears.
The DePuy GLOBAL ADVANTAGE CTA Humeral Heads can be used with the GLOBAL FX and GLOBAL ADVANTAGE Humeral Stems in hemi-shoulder replacement in patients with rotator cuff tears.
The DePuy GLOBAL ADVANTAGE Systems are indicated for the following fixation methods:
POROCOAT™ Porous-Coated Components - Porocoat porous-coated humeral stem prostheses are indicated for cemented or uncemented use with fixation provided by biological tissue ingrowth into the porous coating.
Cemented Components - Humeral Stem and Glenoid components labeled "For cemented use only" are indicated only for use with bone cement.
Press-fit or Cemented Components - Humeral stem prostheses without porous coating and labeled "For press-fit or cemented use only" are indicated for press-fit uncemented use or for use with bone cement.
The DePuy GLOBAL FX Shoulder System is indicated only for hemi-shoulder replacement for the treatment of:
1. A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis;
2. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component);
4. Ununited humeral head fractures;
5. Avascular necrosis of the humeral head.
The DePuy GLOBAL FX Shoulder System is indicated for the following fixation methods:
POROCOAT™ Porous-Coated Components Porocat porous-coated humeral stem prostheses are indicated for cemented or uncemented use with fixation provided by biological tissue ingrowth into the porous coating.
Cemented Components Humeral Stem and Glenoid components labeled "For cemented use only" are indicated only for use with bone cement.
Press-fit or Cemented Components Humeral stem prostheses without porous coating and labeled "For press-fit or cemented use only" are indicated for press-fit uncemented use or for use with bone cement.
The DePuy GLOBAL™ CAP Resurfacing Shoulder Humeral Heads are intended as a total or hemi-shoulder replacement in patients where the humeral head and neck are of sufficient bone stock cuff is intact or reconstructable. This device is designed to increase shoulder mobility by: reducing alignment; restoring flexion and extension movement: and resisting dislocation.
The DePuy GLOBAL™ CAP Resurfacing Shoulder Humeral Heads are indicated for use as a replacement of shoulder joints disabled by rheumatoid arthritis with pain, non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis), deformity and/or limited motion, fractures of the humeral head and traumatic arthritis.
The DePuy GLOBAL™ CAP Resurfacing Shoulder Humeral Heads are intended for uncemented use only.
The DePuy GLOBAL ™ CAP CTA Resurfacing Shoulder is indicated only for hemi-shoulder replacement in patients with rotator cuff tears and arthritis. Specific indications include:
1. Rotator cuff tear arthropathy.
2. Difficult clinical management problems where other methods of treatment may not be inadequate.
The DePuy GLOBAL ™CAP CTA Resurfacing Shoulder Humeral Heads are intended for uncemented use only.
The Glenoid is intended for use in total shoulder replacement surgery for patients suffering from:
1. A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis
2. Fracture-dislocations of the proximal humerus where the articular surface is severely communited, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g revision of a failed primary component).
Glenoid components are intended for cemented use only.
The DePuy GLOBAL AP Shoulder System is indicated for use in total or hemi-shoulder replacement for the treatment of:
1. A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis;
2. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).
The DePuy GLOBAL AP Shoulder Systems is also indicated for hemi-shoulder replacement for the treatment of:
1. Ununited humeral head fractures;
2. Avascular necrosis of the humeral head.
The DePuy GLOBAL AP CTA Humeral Heads are indicated only for hemi-shoulder replacement in patients with rotator cuff tears.
The GLOBAL AP CTA Humeral Head can be used with the GLOBAL AP Humeral Stem in hemi-shoulder replacement in patients with rotator cuff tears.
The DePuy GLOBAL AP Shoulder Systems are indicated for the following fixation methods:
POROCOAT™ Porous-Coated Components - Porocoat porous-coated humeral stem prostheses are indicated for cemented or uncemented use with fixation provided by biological tissue ingrowth into the porous coating.
Cemented Components - Humeral Stem and Glenoid components labeled "For cemented use only" are indicated only for use with bone cement.
Press-fit or Cemented Components - Humeral stem prostheses without porous coating and labeled "For press-fit or cemented use only" are indicated for press-fit uncemented use or for use with bone cement.
The StepTech Anchor Peg Glenoid is intended for use in total shoulder replacement surgery for patients suffering from:
1. A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis
2. Fracture-dislocations of the proximal humerus where the articular surface is severely communited, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).
Glenoid components are intended for cemented use only.
The Glenoid is intended for use in total shoulder replacement surgery for patients suffering from:
1. A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis
2. Fracture-dislocations of the proximal humerus where the articular surfaces are severely communited, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).
Glenoid components are intended for cemented use only.
The DELTA CTA™ Reverse Shoulder Prosthesis is indicated for use in:
1. Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint.
2. The DELTA CTA™ hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for revision surgery in cases with insufficient glenoid bone stock.
3. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional Deltoid muscle is necessary to use the device.
For US use only: All components are intended for cemented use only
Device Description
The Global Shoulder System is comprised of multiple brands (Global Advantage, Global FX, Global AP, Global CAP, Global APG and Global Steptech), each comprised of different components (humeral stems, humeral heads and glenoids) intended for hemiand/or total-shoulder arthroplasty.
The DELTA CTA System is comprised of components intended for reverse shoulder arthroplasty.
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