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510(k) Data Aggregation
K Number
K111596Device Name
TOTAL SHOULDER SYSTEM
Manufacturer
SHOULDER INNOVATIONS, LLC
Date Cleared
2011-07-05
(27 days)
Product Code
KWS, HSD, KWT
Regulation Number
888.3660Why did this record match?
Applicant Name (Manufacturer) :
SHOULDER INNOVATIONS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Shoulder Innovations Total Shoulder System is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following:
- significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
- united humeral head fractures of long duration: .
- . irreducible 3- and 4-part proximal humeral fractures:
- avascular necrosis of the humeral head. .
The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty.
The Total Shoulder System components are intended for single use only. The glenoid components are intended for cemented fixation only; the humeral stem mav be implanted by press-fit or cement fixation.
Device Description
The Shoulder Innovations Total Shoulder System consists of modular humeral stems and heads, and a glenoid component. The humeral stems are manufactured from Cobalt Chrome (CoCr) and have fins to provide rotational stability. The fins have suture holes for the attachment of soft tissue and bone in the case of proximal humeral fracture. A collar is present to resist stem subsidence. The stems have a male Morse-type taper to interface with the modular humeral heads.
The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a female Morsetype taper to interface with the humeral stems.
The glenoid components are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The glenoid implants are available in a multi-pegged and keeled design and are intended for cemented fixation only.
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K Number
K110905Device Name
TOTAL SHOULDER SYSTEM
Manufacturer
SHOULDER INNOVATIONS, LLC
Date Cleared
2011-05-24
(54 days)
Product Code
KWS, HSD, KWT
Regulation Number
888.3660Why did this record match?
Applicant Name (Manufacturer) :
SHOULDER INNOVATIONS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Shoulder Innovations Total Shoulder System is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following:
- significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
- united humeral head fractures of long duration;
- irreducible 3- and 4-part proximal humeral fractures;
- avascular necrosis of the humeral head.
The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty.
The Total Shoulder System components are intended for single use only. The glenoid component is intended for cemented fixation only; the humeral stem may be implanted by press-fit or cement fixation.
Device Description
The Shoulder Innovations Total Shoulder System consists of modular humeral stems and heads, and a glenoid component. The humeral stems are manufactured from Cobalt Chrome (CoCr) and have fins to provide rotational stability. The fins have suture holes for the attachment of soft tissue and bone in the case of proximal humeral fracture. A collar is present to resist stem subsidence. The stems have a male Morse-type taper to interface with the modular humeral heads.
The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a female Morsetype taper to interface with the humeral stems.
The glenoid components are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The glenoid implants are available in a multi-peqged and keeled design and are intended for cemented fixation only.
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K Number
K102670Device Name
TOTAL SHOULDER SYSTEM
Manufacturer
SHOULDER INNOVATIONS, LLC
Date Cleared
2011-01-24
(130 days)
Product Code
KWS, HSD, KWT
Regulation Number
888.3660Why did this record match?
Applicant Name (Manufacturer) :
SHOULDER INNOVATIONS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Shoulder Innovations Total Shoulder System is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following:
- significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
- united humeral head fractures of long duration;
- irreducible 3- and 4-part proximal humeral fractures;
- avascular necrosis of the humeral head.
The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty.
The Total Shoulder System components are intended for single use only. The glenoid component is intended for cemented fixation only; the humeral stem may be implanted by press-fit or cement fixation.
Device Description
The Shoulder Innovations Total Shoulder System consists of modular humeral stems and heads, and a glenoid component. The humeral stems are manufactured from Cobalt Chrome (CoCr) and have fins to provide rotational stability. The fins have suture holes for the attachment of soft tissue and bone in the case of proximal humeral fracture. A collar is present to resist stem subsidence. The stems have a male Morse-type taper to interface with the modular humeral heads.
The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a female Morsetype taper to interface with the humeral stems.
The glenoid component is manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The glenoid is a multi-pegged design and intended for cemented fixation only.
Ask a Question
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