opti-Toe

FDA 510(k) K142478 · Graham Medical Technologies, LLC (D.B.A.Gramedica)

Substantially Equivalent

510(k) numberK142478

Submission

Device name
opti-Toe
Applicant
Graham Medical Technologies, LLC (D.B.A.Gramedica)
Macomb, MI, US
Received
September 3, 2014
Decision date
May 29, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HTY – Pin, Fixation, Smooth
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3040
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code HTY

510(k)DeviceApplicantDecision
K262722Primal K-Wire (P99-193-1410)HTY · Special Paragon 28, Inc.08/28/2026SE
K253325ZipToe™ Hammertoe Fusion SystemHTY · Traditional Toetal Solutions12/29/2025SE
K252657Impact PEEK Union Nail SystemHTY · Special Nvision Biomedical Technologies, Inc.09/19/2025SE
K250315Ronavis – FX (FX-001)HTY · Traditional AIRS, Inc.08/01/2025SE
K251362PediFlex™ Flexible Nail SystemHTY · Traditional OrthoPediatrics Corp.06/24/2025SE
K250646Impact PEEK Union Nail SystemHTY · Traditional Nvision Biomedical Technologies06/11/2025SE
K241014Biomet Kirschner Wires (K-Wires)HTY · Traditional Biomet, Inc.05/22/2024SE
K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…HTY · Traditional OSSIO , Ltd.12/01/2023SE
K231147Hammerdesis™ Interphalangeal Fusion SystemHTY · Traditional Intelivation09/14/2023SE
K230750OSSIOfiber® Cannulated Trimmable Fixation NailHTY · Traditional OSSIO , Ltd.09/13/2023SE

Questions and answers

When was opti-Toe cleared by the FDA?

opti-Toe (K142478) received a 510(k) decision of Substantially Equivalent on May 29, 2015, 268 days after the submission was received.

What is the product code of K142478?

The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.