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 implant is used with the Integra® BioMotion® Cannulated Hemi System as a partial joint replacement for the first metatarsophalangeal joint (MPJ). The Cannulated Implants are made from Titanium Alloy (ASTM F-136). FDA UDI
- Model / Reference
- HM2100 FDA UDI
- Description
- The Integra® BioMotion® Cannulated Hemi implant is used with the Integra® BioMotion® Cannulated Hemi System as a partial joint replacement for the first metatarsophalangeal joint (MPJ). The Cannulated Implants are made from Titanium Alloy (ASTM F-136). FDA UDI
Identifiers
- Catalog Number
- HM2100 FDA UDI
- Primary DI / UDI-DI
- 10381780116387 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
- 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Total metatarsophalangeal joint prosthesis, one-piece
Integra® BioMotion® Cannulated Hemi System by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Total metatarsophalangeal joint prosthesis, one-piece.
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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.
- 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 f75838b2-3ef3-45d4-bfe4-8f28d2c3b872 38 fields · synced May 30, 2026