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510(k) Data Aggregation
K Number
K141006Device Name
RSP HUMERAL SOCKET INSERT
Manufacturer
DJO GLOBAL
Date Cleared
2014-06-05
(48 days)
Product Code
PHX, KWS
Regulation Number
888.3660Why did this record match?
Applicant Name (Manufacturer) :
DJO GLOBAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Reverse® Shoulder Prosthesis (RSP®) is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy, a previously failed joint replacement with a grossly rotator cuff deficient shoulder 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 glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.
The Reverse® Shoulder Prosthesis Monoblock is indicated for patients with a functional deltoid muscle with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint:
- · In cases of fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder, including humeral head fracture or displaced 3- or 4-part fractures of proximal humerus. (For cemented implantation only)
- In cases of bone defect in proximal humerus.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s).
The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented or cementless use.
Device Description
The RSP system is designed so that the "ball" of the articulation fits into the glenoid baseplate, and the "cup" of the articulations fits into a metal cup that is joined to the humeral stem. The components included in this system are a glenoid bead, a humeral stem. The component baseplate, and baseplate screws. The standard RSP system consists of a modular components which include a humeral stem, humeral socket inset, glenoid baseplate, glenoid baseplate, which screws. The RSP Monoblock stem includes a bument test glenoid baseplate, glenoid he screws. The RSP Monoblock socket hiser, greend baseplate, glenoid baseplate, and humeral socket and humeral socket
The modification outlined in this application consists of an addition of a humeral socket insert infused with pure liquid pharmaceutical grade alpha-tocopheral into the material.
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