SpaceFlex Shoulder - Disposable cement spacer molds with metal - G21 SRL

Duns Number:431529195

Device Description: Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold atemporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stagerevision procedure due to a septic process.The temporary prosthesis is molded using low viscosity polymethylmethacrylate bonecement and inserted into the humeral medullary canal and glenoid cavity of the shoulderfollowing removal of the existing humeral and glenoideal cavity implants and debridement.SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy(standard treatment approach to an infection).The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds isnot intended for use more than 180 days, at which time it must be explanted and permanentdevices implanted or another appropriate treatment performed (e.g. resection arthroplasty,fusion, etc.).Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (lowviscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicatedfor patients who will consistently follow activity limitation throughout the implant period.The device can exclusively be used by competent healthcare personnel who has completescientific and anatomical knowledge.

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More Product Details

Catalog Number

-

Brand Name

SpaceFlex Shoulder

Version/Model Number

900001 104215

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K202338

Product Code Details

Product Code

KWS

Product Code Name

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Device Record Status

Public Device Record Key

105cd80e-e6ab-48b0-988a-0e338e1241f5

Public Version Date

March 15, 2021

Public Version Number

1

DI Record Publish Date

March 05, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"G21 SRL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 23