FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Integra® BioMotion® Cannulated Hemi System
DI: 10381780074274
·
Model: BIOMOTIONIMP
·
Ascension Orthopedics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Integra® BioMotion® Cannulated Hemi System
- Primary DI
- 10381780074274
- Version / Model
- BIOMOTIONIMP
- Catalog Number
- BIOMOTIONIMP
- 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
- 5
- Public Version Date
- 2023-05-02
- Public Version Status
- Update
- Public Device Record Key
- b55a5fca-ed68-49ed-b47b-42f8fe058f17
- Distribution End Date
- 2023-03-31
Device Description
The Integra BioMotion Cannulated Hemi System is a partial joint replacement system for the first metatarsophalangeal joint (MPJ). Implants are available in sizes ranging from 15mm to 23mm. The system includes instruments to facilitate the placement of the implants. All implants are made from Titanium Alloy, and instrumentation is made from titanium and stainless steel. The BioMotion hemi implant is indicated for use in the treatment of degenerative arthritis in the first MPJ along with hallux limitus/rigidus, hallux valgus and pain or instability.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KWD | PROSTHESIS, TOE, HEMI-, PHALANGEAL | Orthopedic | 888.3730 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33700 | Total metatarsophalangeal joint prosthesis, one-piece | An implantable device designed to replace the metatarsophalangeal (MTP) joint(s) of the foot (toe). The device is made of a single piece of silicone elastomer. It is is intended to treat degenerative or traumatic arthritis, hallux valgus, hallus rigidus, and/or an unstable or painful MTP joint. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | M268BIOMOTIONIMP1 | HIBCC | ||||
| Primary | 10381780074274 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K083469 | 000 |