Duns Number:942377524
Device Description: The Ascension® PyroHemiSphere™ is an uncemented, onecomponent prosthesis for the basal thu The Ascension® PyroHemiSphere™ is an uncemented, onecomponent prosthesis for the basal thumb joint. It has a proximal head that articulates against the trapezium, a planar collar that provides for a simple planar bone resection, and an anatomic shaped stem that is press fit into the canal of the first metacarpal following resection of the base. It is fabricated from a thick pyrocarbon layer encasing a graphite core that is impregnated with one-atomic percent tungsten so it is radiopaque. The Ascension® PyroHemiSphere™ is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.
Catalog Number
PHS44050WW
Brand Name
Ascension® PyroHemiSphere
Version/Model Number
PHS44050WW
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
K041451
Product Code
KYI
Product Code Name
PROSTHESIS, WRIST, CARPAL TRAPEZIUM
Public Device Record Key
5aaf9177-012d-450e-8020-0c90eed757c6
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 09, 2017
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 | 1909 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1404 |
| 3 | A medical device with high risk that requires premarket approval | 12 |
| U | Unclassified | 15 |