Ascension® PyroHemiSphere
Basic Information
- Brand Name
- Ascension® PyroHemiSphere
- Primary DI
- 10381780114543
- Version / Model
- PHS44020WW
- Catalog Number
- PHS44020WW
- Company Name
- Ascension Orthopedics, Inc.
- Labeler DUNS
- 942377524
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-09
- Public Version
- 4
- Public Version Date
- 2023-05-02
- Public Version Status
- Update
- Public Device Record Key
- bc7ce78b-35ea-43e0-a271-5d525a141917
- Distribution End Date
- 2023-03-31
Device Description
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KYI | PROSTHESIS, WRIST, CARPAL TRAPEZIUM | Orthopedic | 888.3770 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40126 | Metacarpal prosthesis | A sterile implantable device designed to replace the proximal end (base) of the first metacarpal of the thumb carpometacarpal (CMC) joint (articulation with the trapezium) typically to treat thumb instability/motion disabilities caused by arthritis or fracture. It is typically a one-piece device, made of one or several materials (e.g., carbon, graphite, metal); implantation may be performed with our without bone cement. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10381780114543 | GS1 | ||||
| Secondary | M268PHS44020WW1 | HIBCC |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K041451 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Size 20 |