ClearanceBrief
Panels › Orthopedic › Product code KTT · Class 2

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Regulation 888.3030

9510(k)s in 12 months (405 all time)
11recalls in 12 months (89 all time)
85recalls that name a 510(k)
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Top companies in KTT

Company510(k)sRecalls
Ebi, L.P.362
Synthes331
Stryker Corp.1115
Orthofix Srl1112
Howmedica Corp.220
Howmedica Osteonics Corp.191
Zimmer, Inc.109
Smith & Nephew160
Wrightmedicaltechnologyinc110
Alliance Medical Corp.90
Decided510(k)Device and applicantCode
Oct 2, 2026K263083Response Ortho Smart Fixator - Hexapod System
Response Ortho Solutions, LLC
KTT
Jun 11, 2026K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System
Synthes (USA) Products, LLC
KTT
Apr 17, 2026K260900DYNEX® External Fixation Systems
Vilex, LLC
KTT
Mar 23, 2026K260112QuikFix External Fixator: Knee-Spanning Pack
Stabiliz Orthopaedics, Inc.
KTT
Jan 20, 2026K253291Excelsior System
Blue Ocean Global
KTT
Dec 19, 2025K253613Monkey Rings External Ring Fixation System
Paragon 28, Inc.
KTT
Dec 19, 2025K253202Hoffmann LRF System
Stryker GmbH, CH
KTT
Nov 25, 2025K252555Medusa Orthopedics Boa External Fixation System
Medusa Orthopedics, LLC
KTT
Nov 20, 2025K252625The Response Ortho Smart Fixator - Hexapod System
Response Ortho Solutions, LLC
KTT
Sep 30, 2025K252106External Fixation Mini Rail System
Paragon 28, Inc.
KTT
Aug 11, 2025K251862External Fixation Bone Distractor
Paragon 28, Inc.
KTT
Aug 8, 2025K250472SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)
Amdt Holdings, Inc.
KTT
May 7, 2025K251128Extremity Medical External Fixation System
Extremity Medical, LLC
KTT
Mar 7, 2025K243798Orthex External Fixation System
OrthoPediatrics Corp.
KTT
Feb 21, 2025K241563Extremity Medical External Fixation System
Extremity Medical, LLC
KTT
Dec 3, 2024K242861TrueLok Elevate
Orthofix Srl, IT
KTT
Nov 1, 2024K242452Monkey Bars Pin to Bar External Fixation System
Paragon 28, Inc.
KTT
Sep 18, 2024K241769Response Ortho Metaphyseal Hinge Fixator System
Response Ortho Solutions, LLC
KTT
May 30, 2024K233025Revolution External Plating System
New Standard Device Dba Metalogix
KTT
May 29, 2024K240049LINK(TM) External Fixator
Metric Medical Devices, Inc.
KTT
Dec 21, 2023K233741Hoffmann LRF System
Stryker GmbH, CH
KTT
Nov 30, 2023K221787Auxein's DHS/DCS Plate System
Auxein Medical Private Limited, IN
KTT
Oct 18, 2023K232897Arthrex Small External Fixation System
Arthrex, Inc.
KTT
Oct 12, 2023K232838Monkey RingsTM External Fixation System
Paragon 28, Inc.
KTT
Jul 26, 2023K231922DEPUY SYNTHES MAXFRAME AUTOSTRUT System
DePuy Synthes
KTT
Jun 16, 2023K231461Smart Correction System (HA Half Pins)
Wishbone Medical, Inc.
KTT
Feb 10, 2023K223786Orthex External Fixation System
OrthoPediatrics Corp.
KTT
Aug 25, 2022K213905ONX Large External Fixation System
Orthonovis, Inc.
KTT
Jun 6, 2022K221366Smart Correction System Rings and Compatible HA-Coated Half Pins
Wishbone Medical, Inc.
KTT
Apr 8, 2022K220809Drive Rail System
OrthoPediatrics Corp.
KTT
Nov 8, 2021K212895Paragon 28 External Ring Fixation System
Paragon 28, Inc.
KTT
Nov 5, 2021K212044TrueLok Evo
Orthofix Srl, IT
KTT
Oct 12, 2021K212552Correx Software
Vilex, LLC
KTT
Jul 29, 2021K210953SMART Taylor Spatial Frame
Smith & Nephew, Inc.
KTT
May 25, 2021K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)
Synthes (USA) Products, LLC
KTT
May 5, 2021K211112OIC External Fixation System
Orthopaedic Implant Company
KTT
Feb 1, 2021K203568Hoffmann LRF System
Stryker GmbH
KTT
Jan 19, 2021K202833Sequel External Fixation Device
Sequel Medical, Inc.
KTT
Jan 6, 2021K202810AutoStrut G2
Orthospin, Ltd., IL
KTT
Jan 5, 2021K200491Bfix Orthopedic External Fixator Systems
Aike (Shanghai) Medical Instrument Co., Ltd., CN
KTT
Dec 8, 2020K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fix
Smith & Nephew
KTT
Nov 16, 2020K202762Circular Fixation with Balanced Cable Transport
Smith & Nephew, Inc.
KTT
Oct 6, 2020K200728Pitkar DeftFix System
S.H.Pitkar Orthotools Pvt. , Ltd., IN
KTT
Sep 22, 2020K200123Accessories for the SixFix® Hexapod Fixator
Arrowhead De, LLC
KTT
Sep 18, 2020K193368Smart Correction System
Wishbone Medical, Inc.
KTT
Sep 14, 2020K200343FusionFrame Ring Lock System
Glw Medical Innovation
KTT
Sep 11, 2020K202143Dynex Micro
Vilex, LLC
KTT
Aug 24, 2020K202054Dynex Ring Fixation System, Diametrix Ring Fixation System
Vilex, LLC
KTT
Jul 29, 2020K200518Pitkar External Fixation System - Rail Mechanism
S.H.Pitkar Orthotools Pvt. , Ltd., IN
KTT
Nov 7, 2019K192181PRECICE Plating System
Nuvasive Specialized Orthopedics, Inc.
KTT

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