Identity
- Trade Name
- Integra® MOVEMENT® Great Toe System FDA UDI
- Generic Name
- Total metatarsophalangeal joint prosthesis, one-piece FDA UDI
- Device Name
- The Integra Movement Great Toe System metatarsal component is designed for resurfacing the 1st metatarsal head. The component is an anatomically designed, monolithic device.The device is made from cobalt chromium alloy with a commercially pure titanium plasma spray. The metatarsal is intended as hemi-arthroplasty at the surface and is a press-fit. FDA UDI
- Model / Reference
- MGT89020MT FDA UDI
- Description
- The Integra Movement Great Toe System metatarsal component is designed for resurfacing the 1st metatarsal head. The component is an anatomically designed, monolithic device.The device is made from cobalt chromium alloy with a commercially pure titanium plasma spray. The metatarsal is intended as hemi-arthroplasty at the surface and is a press-fit. FDA UDI
Identifiers
- Catalog Number
- MGT89020MT FDA UDI
- Primary DI / UDI-DI
- 10381780116424 FDA UDI
- 510(k) Number
- K092047 FDA UDI
- FDA Product Code
- KWD FDA UDI
- GMDN Term
- Total metatarsophalangeal joint prosthesis, one-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3730 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® MOVEMENT® Great Toe System 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
K092047 also covers:
- Integra® MOVEMENT® Great Toe System — Ascension Orthopedics, Inc.
- Integra® MOVEMENT® Great Toe System — Ascension Orthopedics, Inc.
- Integra® MOVEMENT® Great Toe System — Ascension Orthopedics, Inc.
- Integra® MOVEMENT® Great Toe System — Ascension Orthopedics, Inc.
- Integra® MOVEMENT® Great Toe System — Ascension Orthopedics, Inc.
- Integra® MOVEMENT® Great Toe System — Ascension Orthopedics, Inc.
- Integra® MOVEMENT® Great Toe System — Ascension Orthopedics, Inc.
- Movement® — Ascension Orthopedics, Inc.
- Movement® — Ascension Orthopedics, Inc.
- Movement® — Ascension Orthopedics, Inc.
- Movement® — Ascension Orthopedics, Inc.
- Movement® — Ascension Orthopedics, Inc.
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 9626e496-ccf0-4c30-ad9f-c83434a3d475 38 fields · synced Jun 8, 2026