FDA UDI
Not in Commercial Distribution
🇺🇸 United States
K2™ Hemi Toe Implant System
DI: 10381780065562
·
Model: 201030
·
Ascension Orthopedics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- K2™ Hemi Toe Implant System
- Primary DI
- 10381780065562
- Version / Model
- 201030
- Catalog Number
- 201030
- 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
- 7
- Public Version Date
- 2023-05-02
- Public Version Status
- Update
- Public Device Record Key
- 6df7de85-ddfb-45c9-bfdc-19b27d1d4b0b
- Distribution End Date
- 2023-03-31
Device Description
The K2 Hemi Toe implant is intended for cement fixation by means of a stem, which is inserted into the medullary canal of the phalanx. It is indicated for use in patients with osteoarthritis of the first metatarsophalangeal joint, trauma involving the first metatarsophalangeal joint, hallux rigidus with degenerative joint disease or arthritis.
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
- Yes
- 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 |
|---|---|---|---|---|
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | Orthopedic | 888.3730 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33696 | Partial metatarsophalangeal joint prosthesis | An implantable artificial substitute for the distal head of the metatarsal or the adjacent phalangeal base, intended to repair an articulating surface of the metatarsophalangeal (MTP) joint of the foot (toe). The device is made of metal or a metal/polymer combination, and may contain hyaluronic acid; implantation may be performed with or without bone cement. The device 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 | M2482010301 | HIBCC | ||||
| Primary | 10381780065562 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K023770 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 16.2 mm dia x 14.7 mm L; Size 3 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.