Opti-Toe
by Graham Medical Technologies, LLC (D.B.A.Gramedica) 510(k)
Active
510(k) K142478
Overview
The Opti-Toe is a hammertoe correction implant used for surgical treatment of hammertoe deformity. It is designed to provide structural support and correction for the toe joint. The implant is part of the product code HTY category for orthopedic devices.
The Opti-Toe is supplied as a single-use implant and requires appropriate surgical techniques for implantation. It is stored according to standard medical device protocols and is MRI conditional. The device has FDA 510(k) clearance with number K142478, making it substantially equivalent to predicate devices for hammertoe correction.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK142478 | Date29 May 2015 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HTY
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3040
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
From the manufacturer
Every item is ready for onboarding, clinical demonstration, and procurement. Implant Opti-Toe® Hammertoe correction implant. Implant Osteo-Wedge® Bone-wedge system for precise osteotomy. Instrument Stevens Tenotomy Scissors Precision tenotomy. Fine tissue plane. Instrument Graham Decompression Scissors Signature decompression. Sinus tarsi prep.
Other devices from Graham Medical Technologies, LLC
Questions
What is the Opti-Toe implant used for?
The Opti-Toe is a hammertoe correction implant designed for surgical treatment of hammertoe deformity. It provides structural support and correction for the toe joint, helping to restore proper alignment and function.
Is the Opti-Toe supplied as a single-use device?
Yes, the Opti-Toe is supplied as a single-use implant and requires appropriate surgical techniques for implantation. It should not be reused or resterilized for patient safety and effectiveness.
What regulatory clearance does the Opti-Toe have?
The Opti-Toe has FDA 510(k) clearance with number K142478, making it substantially equivalent to predicate devices for hammertoe correction. It is classified under product code HTY for orthopedic devices.
How should the Opti-Toe be stored?
The Opti-Toe should be stored according to standard medical device protocols. As an implant, it requires proper environmental controls to maintain its integrity until use, typically in a clean, dry environment away from extreme temperatures.