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Cerclage, Fixation

FDA product code JDQ · 123 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3010
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1984-10-26 – 2026-07-16

JDQ 2026-07-16

Cable-Ready® Cable Grip System

Applicant Pioneer Surgical Technology, Inc.

K number K261271

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JDQ 2025-08-14

Stitch Cerclage – Suture Tapes

Applicant GM Dos Reis Industria e Comercio Ltda.

K number K243905

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JDQ 2025-02-20

Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures

Applicant Arthrex, Inc.

K number K243344

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JDQ 2024-05-03

Mbrace Cable

Applicant Medacta International S.A.

K number K232733

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JDQ 2024-03-13

ACCORD Cable System

Applicant Smith & Nephew, Inc.

K number K233949

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JDQ 2024-01-30

VariTrax Sternal CircumFixation System

Applicant Circumfix Solutions, Inc.

K number K232986

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JDQ 2023-08-24

Arthrex Radiopaque FiberTape Cerclage sutures

Applicant Arthrex, Inc.

K number K230976

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JDQ 2023-08-04

STRETTO™ Cable System

Applicant Globus Medical, Inc.

K number K231333

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JDQ 2023-07-26

HS Fiber Cerclage

Applicant Riverpoint Medical, LLC

K number K220765

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JDQ 2022-10-19

STERN FIX Sternal Stabilization System

Applicant Neos Surgery S.L

K number K221795

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JDQ 2022-01-19

Stern Fix Sternal Stabilization System

Applicant Neos Surgery S.L

K number K211613

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JDQ 2020-10-28

EVOS Cabling System

Applicant Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

K number K201497

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JDQ 2020-10-16

Dall-Miles® Cable System

Applicant Howmedica Osteonics Corp., Dba Stryker Orthopaedics

K number K202016

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JDQ 2020-03-23

Sternal Cable System

Applicant A & E Medical Corporation

K number K193479

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JDQ 2020-03-12

Tritium Sternal Cable Plate System

Applicant Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

K number K193468

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JDQ 2018-10-12

Thorecon Rigid Fixation System

Applicant A & E Medical Corporation

K number K181607

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JDQ 2018-09-14

Impress SFS System

Applicant Cable Fix Medical, LLC

K number K173910

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JDQ 2018-08-01

SuperCable® Iso-Elastic™ Cerclage System

Applicant Kinamed, Incorporated

K number K181749

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JDQ 2018-06-21

DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional

Applicant Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.

K number K172975

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JDQ 2018-05-31

Sternal Cable System

Applicant A & E Medical Corporation

K number K180582

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JDQ 2018-02-12

Thorecon™ Fixation System

Applicant A & E Medical Corporation

K number K173579

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JDQ 2017-11-15

Arthrex FiberTape Cerclage

Applicant Arthrex, Inc.

K number K170206

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JDQ 2016-09-09

Tritium® Sternal Cable Plate System

Applicant Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.

K number K161876

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JDQ 2016-04-06

KLS Martin LSS Plating System

Applicant KLS Martin L.P.

K number K151983

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JDQ 2016-01-15

Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System

Applicant Zimmer, Inc.

K number K151848

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JDQ 2016-01-13

Frontier Medical Devices In-Line Orthopedic Cable Cerclage System

Applicant Frontier Medical Devices, Inc.

K number K153242

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JDQ 2013-07-25

COMPRESSYN BAND

Applicant Dallen Medical, Inc.

K number K130431

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JDQ 2012-09-13

JAZZ SYSTEM

Applicant Implanet, S.A.

K number K121541

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JDQ 2012-07-03

SPINAL ELEMENTS CERCLAGE SYSTEM

Applicant Spinal Elements, Inc.

K number K120177

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JDQ 2012-02-01

PASS LP SPINAL

Applicant Medicrea International

K number K112736

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JDQ 2011-07-28

SYNTHES STERNAL ZIPFIX SYSTEM

Applicant Synthes (Usa)

K number K110789

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JDQ 2011-07-06

FIGURE 8 STERNOTOMY CLOSURE DEVICE

Applicant Figure 8 Surgical, Incorporated

K number K110541

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JDQ 2011-05-20

K2M COCR WIRE

Applicant K2m, Inc.

K number K103797

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JDQ 2011-05-03

BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM

Applicant Biomet Sports Medicine

K number K110039

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JDQ 2011-04-01

COMPRESSYN BAND

Applicant Dallen Medical

K number K101484

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JDQ 2011-01-12

ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER)

Applicant Kinamed, Incorporated

K number K102834

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JDQ 2009-12-08

SIC BREVETTI S.R.L. DEVICE FOR STERNAL SYNTHESIS

Applicant Sic Brevetti S.R.L.

K number K090686

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JDQ 2009-07-30

UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063

Applicant Zimmer Spine, Inc.

K number K091190

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JDQ 2008-08-29

UNIVERSAL CLAMP STAINLESS STEEL SYSTEM

Applicant Abbott Spine, Inc.

K number K081622

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JDQ 2008-07-01

SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS

Applicant Synthes (Usa)

K number K081205

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JDQ 2007-10-23

BIOMET CABLE SYSTEM

Applicant Biomet Manufacturing, Inc.

K number K071271

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JDQ 2006-12-27

AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM

Applicant Aesculap, Inc.

K number K063017

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JDQ 2006-03-06

ABBOTT SPINE UNIVERSAL CLAMP SYSTEM

Applicant Abbott Spine, Inc.

K number K060009

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JDQ 2005-02-25

SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM

Applicant Synthes (Usa)

K number K050041

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JDQ 2005-01-14

CABLING SYSTEM TROCHANTER HOOK

Applicant Smith & Nephew, Inc.

K number K043252

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JDQ 2004-03-02

SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM

Applicant Synthes (Usa)

K number K033816

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JDQ 2004-02-20

OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS

Applicant Osseus, LLC

K number K040199

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JDQ 2003-10-21

ISO-ELASTIC CERCLAGE SYSTEM

Applicant Kinamed, Inc.

K number K030256

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JDQ 2003-05-30

SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM

Applicant Synthes (Usa)

K number K031508

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JDQ 2003-05-01

SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM

Applicant Smith & Nephew, Inc.

K number K031162

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JDQ 2003-03-11

OSSE-LIGN

Applicant Osseus, LLC

K number K023564

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JDQ 2001-06-27

SYNTHES STERNAL FIXATION SYSTEM

Applicant Synthes (Usa)

K number K010943

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JDQ 2001-03-21

PECTOFIX STERNAL REPAIR WIRE

Applicant Pectofix, Inc.

K number K003951

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JDQ 2000-12-13

ORTHOMATRIX, INC. CERCLAGE SYSTEM

Applicant Orthomatrix, Inc.

K number K001254

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JDQ 2000-10-06

SPL CRIMP SYSTEM

Applicant Pioneer Surgical Technology

K number K002110

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JDQ 2000-08-31

TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODEL 501-066, 501-067

Applicant Pioneer Surgical Technology

K number K001709

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JDQ 2000-05-11

PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF)

Applicant Pectofix, Inc.

K number K000694

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JDQ 2000-02-14

WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013

Applicant Whiteside Biomechanics, Inc.

K number K993903

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JDQ 1999-11-23

PIONEER SILICOAT STERNAL CABLE

Applicant Pioneer Surgical Technology

K number K993286

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JDQ 1999-11-02

SYNTHES CERCLAGE POSITIONING PIN

Applicant Synthes (Usa)

K number K992891

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JDQ 1999-10-27

SDB CERCLAGE SYSTEM

Applicant Pioneer Surgical Technology

K number K992616

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JDQ 1999-02-24

DALL-MILES CABLE GRIP (A-GRIP)

Applicant Howmedica Osteonics Corp.

K number K984432

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JDQ 1998-12-30

METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM

Applicant Metagen, LLC

K number K983976

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JDQ 1998-10-19

BMP CABLE SYSTEM

Applicant Biomet, Inc.

K number K982545

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JDQ 1998-05-22

CABLE SCREW WITH INTEGRAL CRIMP

Applicant Pioneer Surgical Technology

K number K980690

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JDQ 1997-12-19

SPINAL CONCEPTS, INC., CFIX CABLE SYSTEM

Applicant Spinal Concepts, Inc.

K number K974020

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JDQ 1997-12-19

CERCLAGE CABLE WITH HEX BUTTON

Applicant Pioneer Surgical Technology

K number K974016

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JDQ 1997-10-27

COMPRESSION CERCLAGE GUNDOLF CCG-GF

Applicant Plus Orthopedics

K number K973098

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JDQ 1997-08-11

METAGEN ACTIVELOCK CERCLAGE SYSTEM

Applicant Pacific Materials and Interfaces

K number K972327

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JDQ 1997-07-16

DALL-MILES HOMOGENEOUS STAINLESS STEEL CABLE AND BEADED CABLE

Applicant Howmedica Corp.

K number K971741

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JDQ 1997-03-13

LINK CERCLAGE WIRE SYSTEM

Applicant Turnkey Intergration USA, Inc.

K number K970084

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JDQ 1996-08-14

DALL-MILES TROCHANTER CABLE SUPERGRIP

Applicant Howmedica Corp.

K number K962162

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JDQ 1996-08-08

SILKON STAINLESS STEEL CABLE SYSTEM

Applicant Osteonics Corp.

K number K962132

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JDQ 1996-06-27

PIONEER SYSTEM GTR(GREATER TROCHANTEER REATTACHMENT) DEVICE

Applicant Pioneer Surgical Technology

K number K961267

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JDQ 1996-06-24

DALL-MILES STAINLESS STEEL BEADED CABLE

Applicant Howmedica Corp.

K number K961569

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JDQ 1996-05-22

DALL-MILES HOMOGENOUS VITALLIUM CABLE

Applicant Howmedica Corp.

K number K961283

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JDQ 1996-05-03

CERCLAGE WIRE CRIMP BLOCK

Applicant Acu-Med, Inc.

K number K960651

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JDQ 1996-03-08

SYNTHES WIRE MOUNT

Applicant Synthes (Usa)

K number K953777

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JDQ 1995-10-12

DALL-MILES SUTURE/BEADED CABLE

Applicant Howmedica Corp.

K number K953818

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JDQ 1995-07-13

BIOMECHANIC LOW-PROFILE CABLE SYSTEM

Applicant Biomechanic, Inc.

K number K951844

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JDQ 1995-03-07

DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLE

Applicant Howmedica Corp.

K number K945294

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JDQ 1995-03-06

CABLE-EASE PLATE AND CABLE SYSTEM - TROCHANTERIC HOOK

Applicant Intermedics Orthopedics

K number K950027

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JDQ 1995-02-17

CABLE-EASE PLATE AND CABLE SYSTEM

Applicant Intermedics Orthopedics

K number K944529

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JDQ 1995-02-14

CCG CERCLAGE SYSTEM

Applicant Encore Orthopedics, Inc.

K number K932024

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JDQ 1995-01-09

SILKON TITANIUM CABLE SYSTEM

Applicant American Medical Electronics, Inc.

K number K942300

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JDQ 1994-12-21

PIONEER LABORATORIES BONE PLATE WITH CERCLAGE CABLES

Applicant Pioneer Surgical Technology

K number K940729

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JDQ 1994-08-01

DALL MILES SYSTEM GROOVED BUTTON

Applicant Howmedica Corp.

K number K934059

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JDQ 1994-05-03

AME(R) UNIVERSIAL CABLE SYSTEM

Applicant American Medical Electronics, Inc.

K number K932687

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JDQ 1994-04-19

SONGER CABLE SYSTEM

Applicant Pioneer Surgical Technology

K number K941213

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JDQ 1994-03-09

FX-CABLELOK CABLE/PLATE SYSTEM

Applicant Buckman Co., Inc.

K number K935950

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JDQ 1994-03-09

FX-CABLELOK(TM) STOP(TROCHANTER HOOK) SYSTEM

Applicant Biodynamic Technologies, Inc.

K number K935646

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JDQ 1994-02-25

CONTROL CABLE SYSTEM

Applicant Depuy, Inc.

K number K934557

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JDQ 1994-02-23

DALL MILES SYSTEM MINICLEAT

Applicant Howmedica Corp.

K number K934058

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JDQ 1994-02-22

SURGICAL ACCESSORIES LOOPED WIRE

Applicant Surgical Accessories, Inc.

K number K934176

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JDQ 1994-02-22

CERCLAGE WIRE CRIMP SLEEVE

Applicant Acu Med, Inc.

K number K931246

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JDQ 1994-01-26

SURGICAL ACCESSORIES COCR CABLE SYSTEM

Applicant Surgical Accessories, Inc.

K number K935592

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JDQ 1994-01-26

SPONGER CABLE SYSTEM, MODIFICATION

Applicant Pioneer Surgical Technology

K number K935481

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JDQ 1993-11-30

ORTHOPAEDIC POLYETHYLENE CABLE

Applicant Smith & Nephew Richards, Inc.

K number K924141

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JDQ 1993-06-29

OTI ORTHOPEDIC WIRE SYSTEM

Applicant Osteo Technology, Inc.

K number K925447

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JDQ 1993-05-19

STERNAL BAND

Applicant Stony Brook Surgical Innovations, Inc.

K number K930015

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