FDA Product Code HTY: Pin, Fixation, Smooth
FDA product code HTY covers smooth fixation pins used in orthopedic and trauma surgery.
These thin, smooth Kirschner wires and Steinmann pins are used to temporarily or definitively stabilize fracture fragments, guide cannulated screws, and fix small bones of the hand, wrist, and foot. Their smooth surface allows removal without disrupting surrounding tissue after healing.
HTY devices are Class II medical devices, regulated under 21 CFR 888.3040 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Arthrex, Inc., OSSIO , Ltd. and Synthes (Usa).
204
Total
204
Cleared
114d
Avg days
1977
Since
Declining activity -
5 submissions in the last 2 years
vs 8 in the prior period
Review times improving: avg
90d
recently vs 114d historically
FDA 510(k) Cleared Pin, Fixation, Smooth Devices (Product Code HTY)
204 devices
Cleared
Dec 29, 2025
ZipToe™ Hammertoe Fusion System
Toetal Solutions
Orthopedic
90d
Cleared
Sep 19, 2025
Impact PEEK Union Nail System
Nvision Biomedical Technologies, Inc.
Orthopedic
28d
Cleared
Aug 01, 2025
RONAVIS – FX (FX-001)
AIRS, Inc.
Orthopedic
178d
Cleared
Jun 24, 2025
PediFlex™ Flexible Nail System
OrthoPediatrics Corp.
Orthopedic
54d
Cleared
Jun 11, 2025
Impact PEEK Union Nail System
Nvision Biomedical Technologies
Orthopedic
99d
Cleared
May 22, 2024
Biomet Kirschner Wires (K-Wires)
Biomet, Inc.
Orthopedic
40d
Cleared
Dec 01, 2023
OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail
OSSIO , Ltd.
Orthopedic
213d
Cleared
Sep 14, 2023
Hammerdesis™ Interphalangeal Fusion System
Intelivation
Orthopedic
146d
Cleared
Sep 13, 2023
OSSIOfiber® Cannulated Trimmable Fixation Nail
OSSIO , Ltd.
Orthopedic
180d
Cleared
Aug 14, 2023
Electro-Spec Steri-Caps
Electro-Spec, Inc.
Orthopedic
46d
Cleared
Jul 06, 2023
Tyber Medical Pin and Wire System (various)
Tyber Medical, LLC
Orthopedic
59d
Cleared
Sep 06, 2022
Hammertoe Truss System (HTS)
4Web Medical, Inc.
Orthopedic
126d
Cleared
Jul 22, 2022
SECURE-LOCK
Xiros, Ltd.
Orthopedic
115d
Cleared
Feb 17, 2022
Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires
Pacific Instruments
Orthopedic
59d
Cleared
Jan 04, 2022
restor3d Pin Implants
Restor3d
Orthopedic
208d
Cleared
Sep 30, 2021
Small Bone Nailing System
Skeletal Dynamics, Inc.
Orthopedic
143d
Cleared
May 04, 2021
CoLink Sfx Implant System
In2bones USA, LLC
Orthopedic
137d
Cleared
Feb 05, 2021
LimaCorporate Kirschner Wire
Lima Corporate S.P.A.
Orthopedic
72d
Cleared
Jan 29, 2021
PediFlex Flexible Nail System
OrthoPediatrics Corp.
Orthopedic
211d
Cleared
Jan 06, 2021
OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design
OSSIO , Ltd.
Orthopedic
43d
Cleared
Nov 17, 2020
VeriFixx™ Small Bone Implant
Armis Biopharma, Inc.
Orthopedic
56d
Cleared
Oct 16, 2020
OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant
OSSIO , Ltd.
Orthopedic
108d
Cleared
Aug 05, 2020
Smart Toe II, X Fuse
Stryker GmbH
Orthopedic
43d
Cleared
Jun 29, 2020
Arthrex DynaNite K-Wire
Arthrex, Inc.
Orthopedic
168d
About Product Code HTY - Regulatory Context
510(k) Submission Activity
204 total 510(k) submissions under product code HTY since 1977, with 204 receiving FDA clearance (average review time: 114 days).
Submission volume has declined in recent years - 5 submissions in the last 24 months compared to 8 in the prior period.
FDA 510(k) Review Time - HTY Product Code
Recent submissions under HTY have taken an average of 90 days to reach a decision - down from 114 days historically, suggesting improved FDA processing for this classification.
HTY devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →