FDA Product Code HTN: Washer, Bolt Nut
FDA product code HTN covers washers, bolts, and nuts used as components of orthopedic fixation constructs.
These hardware components provide load distribution, locking, and mechanical interface functions within complex fracture fixation systems. They are used in conjunction with bone screws, plates, and rods to create stable constructs for the treatment of complex fractures and deformities.
HTN devices are Class II medical devices, regulated under 21 CFR 888.3030 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Arthrex, Inc., Dallen Medical, Inc. and Synthes (Usa).
93
Total
93
Cleared
112d
Avg days
1984
Since
Growing category -
8 submissions in the last 2 years
vs 6 in the prior period
Review times increasing: avg
130d
recently vs 110d historically
FDA 510(k) Cleared Washer, Bolt Nut Devices (Product Code HTN)
93 devices
Cleared
Jun 10, 2026
LARS ACJ
Movmedix S.A.S.
Orthopedic
259d
Cleared
Mar 27, 2026
SportLinc Syndesmosis Device
Lincotek Medical
Orthopedic
268d
Cleared
Dec 22, 2025
Syndesmosis TightRope PRO
Arthrex, Inc.
Orthopedic
28d
Cleared
Oct 29, 2025
Synchfix EVT
Wright Medical Technology, Inc. (Stryker Corporation)
Orthopedic
153d
Cleared
Jul 11, 2025
RipCord
TriMed, Inc.
Orthopedic
91d
Cleared
Jan 23, 2025
Acu-Sinch Knotless Mini
Acumed, LLC
Orthopedic
59d
Cleared
Dec 23, 2024
Bolo Button System
Fusion Orthopedics
Orthopedic
159d
Cleared
Nov 27, 2024
TACTIX Vector Syndesmosis System
Vilex, LLC
Orthopedic
26d
Cleared
Nov 01, 2024
EXPERT - Flexible Joint Fixation System
GM Dos Reis Industria e Comercio Ltda.
Orthopedic
88d
Cleared
Aug 01, 2024
TACTIX Vector Syndesmosis System
Vilex, LLC
Orthopedic
210d
Cleared
Jun 03, 2024
TENSOR® Suture Button System
Globus Medical, Inc.
Orthopedic
56d
Cleared
Feb 02, 2024
OIC FLEX-FIX™ System
Orthopaedic Implant Company
Orthopedic
92d
Cleared
Dec 18, 2023
CC-Clip® Implant System
Cc-Instruments, Inc.
Orthopedic
98d
Cleared
Oct 06, 2023
Arthrex FiberTape and TigerTape Cerclage Sutures
Arthrex, Inc.
Orthopedic
28d
Cleared
Aug 22, 2022
Arthrex FiberTape and TigerTape Cerclage Sutures
Arthrex, Inc.
General & Plastic Surgery
91d
Cleared
Jun 06, 2022
Arthrex Knotless AC Repair Devices
Arthrex, Inc.
Orthopedic
66d
Cleared
Jun 01, 2022
TriMed Ripcord Device
TriMed, Inc.
Orthopedic
86d
Cleared
Mar 31, 2022
Hercules Syndesmosis Implant System
In2bones USA, LLC
Orthopedic
59d
Cleared
Jan 07, 2022
Acumed Ankle Syndesmosis Repair System
Acumed, LLC
Orthopedic
109d
Cleared
Dec 17, 2021
Arthrex Knotless Mini TightRopes
Arthrex, Inc.
Orthopedic
29d
Cleared
Dec 10, 2021
Medline UNITE REFLEX Dynamic Discs
Medline Industries, Inc.
Orthopedic
198d
Cleared
Oct 29, 2020
EXPERT - Joint Fixation System
GM Dos Reis Industria e Comercio Ltda.
Orthopedic
262d
Cleared
Sep 03, 2020
Arthrex Syndesmosis TightRope XP Buttress Plate Implant System
Arthrex, Inc.
Orthopedic
87d
Cleared
Apr 06, 2020
Akros Scruture Anchor LisFranc Repair Kit
Akros Medical
Orthopedic
52d
About Product Code HTN - Regulatory Context
510(k) Submission Activity
93 total 510(k) submissions under product code HTN since 1984, with 93 receiving FDA clearance (average review time: 112 days).
Submission volume has increased in recent years - 8 submissions in the last 24 months compared to 6 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - HTN Product Code
Recent submissions under HTN have taken an average of 130 days to reach a decision - up from 110 days historically. Manufacturers should account for longer review timelines in current project planning.
HTN devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →