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.
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
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
KWS
Product Code Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
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 |