Identity
- Trade Name
- Integra® FDA UDI
- Generic Name
- Total metatarsophalangeal joint prosthesis, one-piece FDA UDI
- Device Name
- FGT Implant Size 40 The Integra® Primus Flexible Great Toe (model FGT) is a third generation implant for supplementation of first metatarsophalangeal joint arthroplasty. The implant is constructed from medical grade silicone elastomer and includes titanium grommets. FDA UDI
- Model / Reference
- FGT-40T FDA UDI
- Description
- FGT Implant Size 40 The Integra® Primus Flexible Great Toe (model FGT) is a third generation implant for supplementation of first metatarsophalangeal joint arthroplasty. The implant is constructed from medical grade silicone elastomer and includes titanium grommets. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780257721 FDA UDI
- 510(k) Number
- K981194 FDA UDI
- FDA Product Code
- KWH FDA UDI
- GMDN Term
- Total metatarsophalangeal joint prosthesis, one-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3720 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Total metatarsophalangeal joint prosthesis, one-piece
Integra® by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total metatarsophalangeal joint prosthesis, one-piece.
- Silicone Toe System — Smith & Nephew, Inc. · Class II
- RTS — In2Bones, USA · Class II
- Futura™ FGT — TORNIER, INC. · Class II
- Sgarlato Silastic — FUSION ORTHOPEDICS, LLC · Class II
- Sgarlato Silastic — FUSION ORTHOPEDICS, LLC · Class II
- Futura™ FGT — TORNIER, INC. · Class II
- Silicone Toe System — Smith & Nephew, Inc. · Class II
- Silicone Toe System — Smith & Nephew, Inc. · Class II
Cleared under the same submission
K981194 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ascension Orthopedics, Inc.
Sources (1)
- FDA UDI 389ac5e1-8bb9-459f-ab51-2f8d0e5c0e98 37 fields · synced Jun 1, 2026