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K Number
K012377
Device Name
OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES
Manufacturer
CORIN U.S.A.
Date Cleared
2002-03-11

(228 days)

Product Code
HSD,KWS
Regulation Number
888.3690
Type
Traditional
Panel
OR
Reference & Predicate Devices
K992119
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Oxford Modular Shoulder Prosthesis is indicated for the relief of pain and restoration of function in non-inflammatory degenerative joint disease, including:

  • osteoarthritis .
  • rheumatoid arthritis .
  • revision cases where other devices or treatments have failed .
  • correction of functional deformity .
  • treatment of acute fracture of the humeral head unmanageable using other treatment . methods
  • cuff tear arthroplasty t

Hemi-resurfacing is also indicated for:

  • humeral head fractures ●
  • avascular necrosis of the femoral head .
Device Description

The Oxford Modular Shoulder is a modular total shoulder replacement comprised of 3 components: humeral stem, modular head and glenoid.

The humeral stem and head are made from cobalt-chrome alloy; the glenoid component is made from ultra high molecular weight polyethylene (UHMWPE). The humeral stem has a proximal one-third plasma sprayed coating to provide fixation and a proximal fin with holes to allow for reconstruction of fractures.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (Oxford Modular Shoulder Prosthesis), not a study evaluating an AI device. As such, the provided text does not contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria. The document is concerned with demonstrating substantial equivalence to a predicate device based on manufacturing materials, design features, and indications for use, supported by mechanical testing of component materials.

Therefore, I cannot provide the requested information.

§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.