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

FDA product code KTT · 378 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3030
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1979-04-10 – 2026-06-11

KTT 2026-06-11

MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System

Applicant Synthes (USA) Products, LLC

K number K254087

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KTT 2026-04-17

DYNEX® External Fixation Systems

Applicant Vilex, LLC

K number K260900

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KTT 2026-03-23

QuikFix External Fixator: Knee-Spanning Pack

Applicant Stabiliz Orthopaedics, Inc.

K number K260112

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KTT 2026-01-20

Excelsior System

Applicant Blue Ocean Global

K number K253291

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KTT 2025-12-19

Monkey Rings External Ring Fixation System

Applicant Paragon 28, Inc.

K number K253613

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KTT 2025-12-19

Hoffmann LRF System

Applicant Stryker GmbH

K number K253202

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KTT 2025-11-25

Medusa Orthopedics Boa External Fixation System

Applicant Medusa Orthopedics, LLC

K number K252555

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KTT 2025-11-20

The Response Ortho Smart Fixator - Hexapod System

Applicant Response Ortho Solutions, LLC

K number K252625

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KTT 2025-09-30

External Fixation Mini Rail System

Applicant Paragon 28, Inc.

K number K252106

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KTT 2025-08-11

External Fixation Bone Distractor

Applicant Paragon 28, Inc.

K number K251862

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KTT 2025-08-08

SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)

Applicant Amdt Holdings, Inc.

K number K250472

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KTT 2025-05-07

Extremity Medical External Fixation System

Applicant Extremity Medical, LLC

K number K251128

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KTT 2025-03-07

Orthex External Fixation System

Applicant OrthoPediatrics Corp.

K number K243798

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KTT 2025-02-21

Extremity Medical External Fixation System

Applicant Extremity Medical, LLC

K number K241563

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KTT 2024-12-03

TrueLok Elevate

Applicant Orthofix Srl

K number K242861

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KTT 2024-11-01

Monkey Bars Pin to Bar External Fixation System

Applicant Paragon 28, Inc.

K number K242452

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KTT 2024-09-18

Response Ortho Metaphyseal Hinge Fixator System

Applicant Response Ortho Solutions, LLC

K number K241769

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KTT 2024-05-30

Revolution External Plating System

Applicant New Standard Device Dba Metalogix

K number K233025

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KTT 2024-05-29

LINK(TM) External Fixator

Applicant Metric Medical Devices, Inc.

K number K240049

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KTT 2023-12-21

Hoffmann LRF System

Applicant Stryker GmbH

K number K233741

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KTT 2023-11-30

Auxein's DHS/DCS Plate System

Applicant Auxein Medical Private Limited

K number K221787

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KTT 2023-10-18

Arthrex Small External Fixation System

Applicant Arthrex, Inc.

K number K232897

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KTT 2023-10-12

Monkey RingsTM External Fixation System

Applicant Paragon 28, Inc.

K number K232838

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KTT 2023-07-26

DEPUY SYNTHES MAXFRAME AUTOSTRUT System

Applicant DePuy Synthes

K number K231922

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KTT 2023-06-16

Smart Correction System (HA Half Pins)

Applicant Wishbone Medical, Inc.

K number K231461

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KTT 2023-02-10

Orthex External Fixation System

Applicant OrthoPediatrics Corp.

K number K223786

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KTT 2022-08-25

ONX Large External Fixation System

Applicant Orthonovis, Inc.

K number K213905

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KTT 2022-06-06

Smart Correction System Rings and Compatible HA-Coated Half Pins

Applicant Wishbone Medical, Inc.

K number K221366

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KTT 2022-04-08

Drive Rail System

Applicant OrthoPediatrics Corp.

K number K220809

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KTT 2021-11-08

Paragon 28 External Ring Fixation System

Applicant Paragon 28, Inc.

K number K212895

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KTT 2021-11-05

TrueLok Evo

Applicant Orthofix Srl

K number K212044

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KTT 2021-10-12

Correx Software

Applicant Vilex, LLC

K number K212552

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KTT 2021-07-29

SMART Taylor Spatial Frame

Applicant Smith & Nephew, Inc.

K number K210953

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KTT 2021-05-25

MAXFRAME Multi-Axial Correction System (aka MAXFRAME)

Applicant Synthes (USA) Products, LLC

K number K211313

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KTT 2021-05-05

OIC External Fixation System

Applicant Orthopaedic Implant Company

K number K211112

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KTT 2021-02-01

Hoffmann LRF System

Applicant Stryker GmbH

K number K203568

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KTT 2021-01-19

Sequel External Fixation Device

Applicant Sequel Medical, Inc.

K number K202833

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KTT 2021-01-06

AutoStrut G2

Applicant Orthospin, Ltd.

K number K202810

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KTT 2021-01-05

Bfix Orthopedic External Fixator Systems

Applicant Aike (Shanghai) Medical Instrument Co., Ltd.

K number K200491

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KTT 2020-12-08

Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation

Applicant Smith & Nephew

K number K201253

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KTT 2020-11-16

Circular Fixation with Balanced Cable Transport

Applicant Smith & Nephew, Inc.

K number K202762

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KTT 2020-10-06

Pitkar DeftFix System

Applicant S.H.Pitkar Orthotools Pvt. , Ltd.

K number K200728

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KTT 2020-09-22

Accessories for the SixFix® Hexapod Fixator

Applicant Arrowhead De, LLC

K number K200123

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KTT 2020-09-18

Smart Correction System

Applicant Wishbone Medical, Inc.

K number K193368

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KTT 2020-09-14

FusionFrame Ring Lock System

Applicant Glw Medical Innovation

K number K200343

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KTT 2020-09-11

Dynex Micro

Applicant Vilex, LLC

K number K202143

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KTT 2020-08-24

Dynex Ring Fixation System, Diametrix Ring Fixation System

Applicant Vilex, LLC

K number K202054

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KTT 2020-07-29

Pitkar External Fixation System - Rail Mechanism

Applicant S.H.Pitkar Orthotools Pvt. , Ltd.

K number K200518

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KTT 2019-11-07

PRECICE Plating System

Applicant Nuvasive Specialized Orthopedics, Inc.

K number K192181

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KTT 2019-10-16

Pitkar External Fixation System

Applicant S.H.Pitkar Orthotools Pvt. , Ltd.

K number K190486

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KTT 2019-08-14

AutoStrut

Applicant Orthospin

K number K191241

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KTT 2019-05-29

Revolution External Plating System

Applicant New Standard Device Dba Metalogix

K number K181630

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KTT 2019-05-14

SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)

Applicant Arrowhead De, LLC

K number K190069

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KTT 2019-04-08

OIC External Fixation System

Applicant Orthopaedic Implant Company

K number K183682

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KTT 2019-02-28

Austin Miller Large External Fixation System

Applicant Austin Miller Trauma, LLC

K number K181528

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KTT 2019-01-25

Hoffmann LRF System

Applicant Stryker GmbH

K number K182968

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KTT 2018-10-16

Depuy Synthes Femoral Neck System

Applicant Synthes (USA) Products, LLC

K number K182154

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KTT 2018-09-07

External Fixation System

Applicant Life Spine, Inc.

K number K173883

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KTT 2018-07-27

Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices

Applicant Surgical Instrument Service and Savings, Inc.

K number K180580

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KTT 2018-06-06

SALVATION External Fixation System

Applicant Wrightmedicaltechnologyinc

K number K180832

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KTT 2018-03-05

DePuy Synthes Femoral Neck System

Applicant DePuy Synthes

K number K172872

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KTT 2018-01-12

ARBOR External Fixation System

Applicant Globus Medical, Inc.

K number K172438

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KTT 2017-11-09

Medline ReNewal Reprocessed Synthes External Fixation Systems

Applicant Surgical Instrument Service and Savings, Inc.

K number K171911

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KTT 2017-10-12

Galaxy UNYCO System

Applicant Orthofix Srl

K number K170146

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KTT 2017-09-27

OIC External Fixation System

Applicant Orthopaedic Implant Company

K number K171211

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KTT 2017-09-27

Spider Frame External Fixation System

Applicant Tasarimmed Tibbi Mamuller Sanayi VE Ticaret A.S

K number K170482

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KTT 2017-09-08

The Locking Pediatric Osteotomy Plate (LolliPOP) System

Applicant Pega Medical, Inc.

K number K170704

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KTT 2017-07-24

DRACO Locking Bone Screws; DRACO Compression Screws; DRACO MetaFuse L Plates; DRACO MetaFuse BLP Plates; DRACO MetaFuse MTP Plates, Takú Plates, DuoTakú Plates, Open Wedge Plates, Osteoplate Plates, Plantar Plates, Calcaneus Offset Locking Plates

Applicant Hnm Total Recon, LLC

K number K163486

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KTT 2017-05-10

Orthofix TrueLok Hexapod System (TL-HEX) V2.0

Applicant Orthofix Srl

K number K170650

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KTT 2017-04-14

Hoffmann LRF System

Applicant Stryker GmbH

K number K163656

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KTT 2017-03-20

Dolphix® External Fixation System MR Conditional

Applicant Citieffe S.R.L.

K number K163323

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KTT 2017-03-06

SALVATION External Fixation System

Applicant Wright Medical

K number K162033

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KTT 2017-02-21

Arrowhead Mini-Rail Fixator

Applicant Arrowhead De, LLC

K number K162032

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KTT 2016-12-28

Gexfix External Fixation

Applicant Gexfix International Corp.

K number K160972

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KTT 2016-11-15

Hoffman LRF System

Applicant Stryker GmbH

K number K161753

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KTT 2016-11-10

DePuy Synthes MAXFRAME Multi-Axial Correction System

Applicant Synthes USA, LLC

K number K161417

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KTT 2016-07-06

Integra External Fixation System

Applicant Ascension Orthopedics

K number K160830

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KTT 2016-04-11

Hoffmann LRF (Limb Reconstruction Frame) System

Applicant Stryker GmbH

K number K153377

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KTT 2016-03-24

X-Fix Line Additions

Applicant Vilex IN Tennessee, Inc.

K number K151881

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KTT 2016-02-16

D.N.E. External Fixation System

Applicant Dne, LLC

K number K151580

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KTT 2016-01-13

SALVATION(R) External Fixation System

Applicant Wrightmedicaltechnologyinc

K number K153635

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KTT 2016-01-13

Reprocessed Stryker External Fixation Devices

Applicant Stryker Sustainability Solutions

K number K153415

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KTT 2016-01-06

Galaxy UNYCO System

Applicant Orthofix Srl

K number K153233

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KTT 2013-06-10

HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM

Applicant Stryker Trauma AG

K number K130907

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KTT 2013-05-15

NBX - NON BRIDGING EXTERNAL FIXATOR HAND

Applicant Nutek Orthopaedics, Inc.

K number K122777

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KTT 2013-05-14

ILIZAROV DRILL TIP WIRES

Applicant Smith & Nephew, Inc.

K number K130479

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KTT 2013-05-03

HOFFMANN LRF (LIMB RECONSTRUCTION FRAME SYSTEM)

Applicant Stryker Trauma AG

K number K130334

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KTT 2013-04-19

NEWFIX EXTERNAL FIXATION SYSTEM

Applicant Tecnologia Y Diseno Industrial, S.A DE C.V

K number K122210

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KTT 2013-04-11

SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM

Applicant Synthes

K number K122455

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KTT 2013-04-05

SIDEKICK EZ FRAME EXTERNAL FIXATION SYSTEM

Applicant Wrightmedicaltechnologyinc

K number K130044

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KTT 2012-10-24

HOFFMANN 3

Applicant Stryker Corp.

K number K122284

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KTT 2012-09-04

ORTHOFIX GALAXY FIXATION SYSTEM

Applicant Orthofix Srl

K number K113770

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KTT 2012-07-25

HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM

Applicant Stryker Corp.

K number K121252

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KTT 2012-06-26

XTRAFIX EXTERNAL FIXATION SYSTEM

Applicant Extraortho, Inc.

K number K113383

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KTT 2012-05-01

EXTERNAL FIXATOR ST.A R 90 F4

Applicant Citieffe

K number K113384

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KTT 2012-03-29

HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM

Applicant Stryker Corp.

K number K113327

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KTT 2012-01-26

HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM

Applicant Stryker Corp.

K number K111786

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KTT 2012-01-12

OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM

Applicant The Orthopaedic Implant Company

K number K113123

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KTT 2012-01-04

DNE EXTERNAL FIXATION SYSTEM

Applicant Dne, LLC

K number K113106

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KTT 2011-12-15

ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS

Applicant DePuy Orthopaedics, Inc.

K number K112218

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