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510(k) Data Aggregation
K Number
K173960Device Name
DePuy Corail AMT Hip Prosthesis
Manufacturer
DePuy France S.A.S.
Date Cleared
2018-09-21
(267 days)
Product Code
LZO, KWL, KWY, MEH
Regulation Number
888.3353Why did this record match?
Applicant Name (Manufacturer) :
DePuy France S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Total hip replacement or hip arthroplasty is indicated in the following conditions:
1. A severely painful and/or disabled joint from osteoarthritis, traumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, arthrodesis, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
Partial hip replacement or hip hemi-arthroplasty is indicated in the following conditions:
1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.
2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
3. Avascular necrosis of the femoral head.
4. Non-union of femoral neck fractures.
5. Certain high subcapital and femoral neck fractures in the elderly.
6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemi-arthroplasty.
HA coated stems of the Corail Hip System are indicated for cementless use only.
Device Description
The DePuy Corail AMT hip stems are manufactured from forged titanium alloy (Ti6Al4V) and plasma-sprayed with a hydroxyapatite (HA) coating for bone fixation. The stem consists of a wide range of stem neck designs and sizes allowing an accurate anatomical match for each patient. Corail AMT stems are available with or without a collar, with various neck angles, and with various neck offsets. The stems are compatible with both unipolar and bipolar heads intended for hip hemi-arthroplasty and with modular femoral heads intended for total hip arthroplasty.
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K Number
K123991Device Name
DEPUY CORAIL AMT HIP PROSTHESIS
Manufacturer
DEPUY FRANCE S.A.S.
Date Cleared
2013-09-16
(264 days)
Product Code
KWY, KWL, LZO
Regulation Number
888.3390Why did this record match?
Applicant Name (Manufacturer) :
DEPUY FRANCE S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Total Hip Arthroplasty and Hemi Hip Arthroplasty
Total hip replacement or hip arthroplasty is indicated in the following conditions:
1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
Partial hip replacement or hip hemi-arthroplasty is indicated in the following conditions:
1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.
2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
3. Avascular necrosis of the femoral head.
4. Non-union of femoral neck fractures.
5. Certain high subcapital and femoral neck fractures in the elderly.
6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemi-arthroplasty.
HA coated stems of the Corail Hip System are indicated for cementless use only.
Device Description
The Corail AMT Hip is a tapered stem available both collarless and collared. The stems are manufactured from titanium alloy (Ti6Al4V) and plasma-sprayed with a biocompatible hydroxyapatite (HA) coating for bone fixation. The Corail AMT stems feature a 12/14 modular taper that accepts 12/14 heads with a wide range of diameters. The compatible components for the hip hemi-arthroplasty application are bipolar heads cleared via 510(k) K812672 and unipolar heads cleared via 510(k) K903084. Corail AMT stems are indicated for cementless use only.
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K Number
K122442Device Name
DEPUY CTA REVERSE SHOULDER SYSTEM
Manufacturer
DEPUY FRANCE
Date Cleared
2012-09-06
(27 days)
Product Code
PHX
Regulation Number
888.3660Why did this record match?
Applicant Name (Manufacturer) :
DEPUY FRANCE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A Delta CTA™ Reverse Shoulder Prosthesis is indicated for use in
• Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint.
• 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.
• The metaglene component is HA coated and is intended for cementless application with the addition of screws for fixation. For US Use Only: All other components are intended for cemented use only.
Device Description
The Delta CTA™ Reverse Shoulder is DePuy's first generation reverse shoulder system. In a reverse shoulder, the articulation is "inverted" compared to traditional, anatomical total shoulder prosthesis so that the "ball" of the articulation is incorporated into the glenoid prosthesis and the "cup" of the articulation is incorporated into the humeral prosthesis. This inverted design helps stabilize a shoulder in the absence of a functional rotator cuff.
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K Number
K120174Device Name
DEPUT DELTA XTEND REVERSE SHOULDER
Manufacturer
DEPUY FRANCE
Date Cleared
2012-06-11
(143 days)
Product Code
PHX, HSD, KWS
Regulation Number
888.3660Why did this record match?
Applicant Name (Manufacturer) :
DEPUY FRANCE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Delta Xtend Shoulder Prosthesis is indicated for use in treatment of a grossly deficient rotator cuff joint with:
- . severe arthropathy and/or;
- a previously failed joint replacement and/or: ●
- 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
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.
Delta Xtend hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for the revision of a previously failed Delta Xtend Reverse Shoulder.
The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation.
The modular humeral stem and humeral epiphysis components are HA coated and intended for cementless use.
All other metallic components are intended for cemented use only.
Device Description
The DePuy Delta Xtend™ Reverse Shoulder System is a total shoulder prosthesis that consists of monobloc and modular humeral stems, humeral cup, humeral head, humeral spacer, glenosphere, metaglene and metaglene screws.
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