Identity
- Trade Name
- Integra® MOVEMENT® Great Toe System FDA UDI
- Generic Name
- Partial metatarsophalangeal joint prosthesis FDA UDI
- Device Name
- The Integra Movement Great Toe System total arthroplasty is an anatomically designed, semi-constrained, two-piece device designed for resurfacing of the base of the 1st metatarso-phalangeal (MTP) joint. The device uses the metatarsal hemi arthroplasty device paired with a phalangeal base manufactured from titanium with a UHMWPE articulating surface insert. The phalangeal joint replacement device is intended for cemented use. FDA UDI
- Model / Reference
- MGT89020PPT FDA UDI
- Description
- The Integra Movement Great Toe System total arthroplasty is an anatomically designed, semi-constrained, two-piece device designed for resurfacing of the base of the 1st metatarso-phalangeal (MTP) joint. The device uses the metatarsal hemi arthroplasty device paired with a phalangeal base manufactured from titanium with a UHMWPE articulating surface insert. The phalangeal joint replacement device is intended for cemented use. FDA UDI
Identifiers
- Catalog Number
- MGT89020PPT FDA UDI
- Primary DI / UDI-DI
- 10381780119906 FDA UDI
- 510(k) Number
- K102549 FDA UDI
- FDA Product Code
- LZJ FDA UDI
- GMDN Term
- Partial metatarsophalangeal joint prosthesis FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
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: Partial metatarsophalangeal joint prosthesis
Integra® MOVEMENT® Great Toe System by Ascension Orthopedics, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Partial metatarsophalangeal joint prosthesis.
- TOE JOINT TITANIUM NPC LG 23MM — BIOPRO, INC. · Class II
- MDI — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
- Accu-Joint — ACCUFIX SURGICAL, INC. · Class II
- TOE NON POROUS COATED SMALL 17mm — BIOPRO, INC. · Class II
- Accu-Joint — ACCUFIX SURGICAL, INC. · Class II
- OsteoMed — Osteomed Corp. · U
- Arthrex® — Arthrex, Inc. · Class II
- MDI — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
Cleared under the same submission
K102549 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.
- Movement® — Ascension Orthopedics, Inc.
- Movement® — Ascension Orthopedics, Inc.
- Movement® — Ascension Orthopedics, Inc.
- Movement® — Ascension Orthopedics, Inc.
- Movement Great Toe System — Smith & Nephew, Inc.
- Movement Great Toe System — Smith & Nephew, Inc.
- Movement Great Toe System — Smith & Nephew, Inc.
- Movement Great Toe System — Smith & Nephew, Inc.
- Movement Great Toe System — Smith & Nephew, 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 U | Pending data |
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Manufacturer
- Manufacturer
- Ascension Orthopedics, Inc.
Sources (1)
- FDA UDI f4057d1e-692f-4bc2-b79c-e4c866576e1d 38 fields · synced May 31, 2026