Resorbable Hammertoe Pin
FDA 510(k)Class II (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K011137 FDA 510(k)
- FDA Product Code
- JDW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3040 FDA 510(k)
- Regulation Number
- 888.3040 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Resorbable Hammertoe Pin is a fixation device used in orthopedic procedures. It is designed for the treatment of hammertoe deformities, providing temporary stabilization during the healing process.
This device is supplied as a single-use implant and is not MRI safe. It is stored under standard conditions and has received FDA 510(k) clearance with the product code JDW, classified as a Class 2 orthopedic device.
Frequently asked questions
What is the Resorbable Hammertoe Pin used for?
The Resorbable Hammertoe Pin is a fixation device designed for orthopedic procedures to treat hammertoe deformities by providing temporary stabilization during the healing process.
Is the Resorbable Hammertoe Pin reusable or single-use?
The Resorbable Hammertoe Pin is supplied as a single-use implant, meaning it should be used only once for a single patient procedure and then discarded.
What regulatory approvals does the Resorbable Hammertoe Pin have?
The Resorbable Hammertoe Pin has received FDA 510(k) clearance with product code JDW, classified as a Class 2 orthopedic device, indicating it is substantially equivalent to other legally marketed devices.
Is the Resorbable Hammertoe Pin MRI safe?
No, the Resorbable Hammertoe Pin is not MRI safe, which means it should not be used in patients undergoing MRI scans as it may interfere with the imaging process.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: RESORBABLE HAMMERTOE PIN (K011137) — FDA 510 (k) | Innolitics, K011137 FDA 510 (k) - RESORBABLE HAMMERTOE PIN | Biomet, Inc., RESORBABLE HAMMERTOE PIN 510(k) K011137 - FDA.report, PDF K011137 - Resorbable Hammertoe Pin
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K011137 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K011137 24 fields · synced Sep 26, 2026