Search Results
Found 2 results
510(k) Data Aggregation
K Number
K203375Device Name
OVOMotion Reverse Shoulder Arthroplasty System
Manufacturer
Arthrosurface Inc.
Date Cleared
2021-06-24
(220 days)
Product Code
PHX
Regulation Number
888.3660Why did this record match?
Applicant Name (Manufacturer) :
Arthrosurface Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OVOMotion Reverse Shoulder Arthroplasty System is intended for primary total shoulder replacement in a reverse shoulder configuration. The device is indicated for a patient with painful, disabling joint disease of the shoulder resulting from degenerative arthritis or rheumatoid arthritis. The humeral head and glenoid vault should be of sufficient bone stock to support loading. The patient's joint must have gross rotator cuff deficiency, a functional deltoid muscle and be anatomically suited to receive the selected implants.
Glenoid Baseplate components are intended for cementless use with the addition of screw fixation. The Humeral Stem components are intended for both cemented and cementless use.
Device Description
The OVOMotion Reverse Shoulder Arthroplasty System (RSA) is a system of components intended for total shoulder replacement in a reverse shoulder configuration. The humeral side of the system is comprised of a humeral cup and humeral insert which are attached to the Arthrosurface TSA Humeral Stem using an adapter ring. The glenosphere is implanted with the GlenoidBaseplate onto the glenoid side of the joint fixated with locking Center and Peripheral Screws.
Ask a Question
K Number
K142942Device Name
HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System
Manufacturer
ARTHROSURFACE INC.
Date Cleared
2014-12-19
(66 days)
Product Code
HSD
Regulation Number
888.3690Why did this record match?
Applicant Name (Manufacturer) :
ARTHROSURFACE INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck should be of sufficient bone stock to support loading. The rotator cuff should be intact or reconstructable. The device is a single use implant intended to be used with bone cement.
Device Description
The HemiCAP® Humeral Head XL (HHXL) Articular Resurfacing System incorporates an articular resurfacing component and a taper post fixation component that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/prosthetic interface.
Ask a Question
Page 1 of 1