Identity
- Trade Name
- Integra® BioMotion® Cannulated Hemi System FDA UDI
- Generic Name
- Total metatarsophalangeal joint prosthesis, one-piece FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- BIOMOTIONIMP FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- BIOMOTIONIMP FDA UDI
- Primary DI / UDI-DI
- 10381780074274 FDA UDI
- 510(k) Number
- K083469 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
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Integra® BioMotion® Cannulated Hemi System by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K083469 also covers:
- Integra® BioMotion® Cannulated Hemi System — Ascension Orthopedics, Inc.
- Integra® BioMotion® Cannulated Hemi System — Ascension Orthopedics, Inc.
- Integra® BioMotion® Cannulated Hemi System — Ascension Orthopedics, Inc.
- Integra® BioMotion® Cannulated Hemi System — Ascension Orthopedics, Inc.
- Integra® BioMotion® Cannulated Hemi System — Ascension Orthopedics, Inc.
- BioMotion Cannulated 1st MPJ Hemi System — Smith & Nephew, Inc.
- BioMotion Cannulated 1st MPJ Hemi System — Smith & Nephew, Inc.
- BioMotion Cannulated 1st MPJ Hemi System — Smith & Nephew, Inc.
- BioMotion Cannulated 1st MPJ Hemi System — Smith & Nephew, Inc.
- BioMotion Cannulated 1st MPJ Hemi 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 II | Pending data |
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Manufacturer
- Manufacturer
- Ascension Orthopedics, Inc.
Sources (1)
- FDA UDI b55a5fca-ed68-49ed-b47b-42f8fe058f17 37 fields · synced May 30, 2026