Product Code: JDQ
FDA class 2
21 CFR 888.3010
Cerclage, Fixation
Orthopedic
Cerclage Fixation devices are orthopedic implants consisting of wire or cable loops placed circumferentially around a bone to hold fracture fragments together or to reinforce periprosthetic fractures and osteotomies. They are classified as FDA Class 2 (moderate risk), subject to general controls and requiring 510(k) premarket notification before marketing. The product code is JDQ, regulated under 21 CFR 888.3010, within the Orthopedic medical specialty. This device is flagged as an implant due to its placement within the body during surgical procedures.
510(k)s
128
FEI Numbers
153
Registration Numbers
153
Unique Applicants
80
Years Active
40
Basic Information
- Product Code
- JDQ
- Device Class
- FDA class 2
- Regulation Number
- 888.3010
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✓
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 128 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243344 | Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures | Feb 20, 2025 | Substantially Equivalent | Arthrex Inc. |
| K232733 | Mbrace Cable | May 03, 2024 | Substantially Equivalent | Medacta International S.A. |
| K233949 | ACCORD Cable System | Mar 13, 2024 | Substantially Equivalent | Smith & Nephew, Inc. |
| K232986 | VariTrax Sternal CircumFixation System | Jan 30, 2024 | Substantially Equivalent | CircumFix Solutions, Inc. |
| K230976 | Arthrex Radiopaque FiberTape Cerclage sutures | Aug 24, 2023 | Substantially Equivalent | Arthrex, Inc |
| K231333 | STRETTO Cable System | Aug 04, 2023 | Substantially Equivalent | Globus Medical Inc. |
| K220765 | HS Fiber Cerclage | Jul 26, 2023 | Substantially Equivalent | Riverpoint Medical, LLC |
| K221795 | STERN FIX Sternal Stabilization System | Oct 19, 2022 | Substantially Equivalent | Neos Surgery SL |
| K211613 | Stern Fix Sternal Stabilization System | Jan 19, 2022 | Substantially Equivalent | Neos Surgery SL |
| K201497 | EVOS Cabling System | Oct 28, 2020 | Substantially Equivalent | Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) |
| K202016 | Dall-Miles® Cable System | Oct 16, 2020 | Substantially Equivalent | Howmedica Osteonics Corp., dba Stryker Orthopaedics |
| K193479 | Sternal Cable System | Mar 23, 2020 | Substantially Equivalent | A&E Medical Corporation |
| K193468 | Tritium Sternal Cable Plate System | Mar 12, 2020 | Substantially Equivalent | Pioneer Surgical Technology, Inc. (dba RTI Surgical, Inc.) |
| K181607 | Thorecon Rigid Fixation System | Oct 12, 2018 | Substantially Equivalent | A&E Medical Corporation |
| K173910 | Impress SFS System | Sep 14, 2018 | Substantially Equivalent | Cable Fix Medical LLC |
| K181749 | SuperCable® Iso-Elastic Cerclage System | Aug 01, 2018 | Substantially Equivalent | Kinamed, Incorporated |
| K172975 | 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 | Jun 21, 2018 | Substantially Equivalent | Synthes (USA) Products LLC/DePuy Orthopaedics Inc |
| K180582 | Sternal Cable System | May 31, 2018 | Substantially Equivalent | A & E Medical Corporation |
| K173579 | Thorecon Fixation System | Feb 12, 2018 | Substantially Equivalent | A&E Medical Corporation |
| K170206 | Arthrex FiberTape Cerclage | Nov 15, 2017 | Substantially Equivalent | ARTHREX, INC. |
| K161876 | Tritium® Sternal Cable Plate System | Sep 09, 2016 | Substantially Equivalent | Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. |
| K151983 | KLS Martin LSS Plating System | Apr 06, 2016 | Substantially Equivalent | KLS MARTIN L.P. |
| K151848 | Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System | Jan 15, 2016 | Substantially Equivalent | ZIMMER, INC. |
| K153242 | Frontier Medical Devices In-Line Orthopedic Cable Cerclage System | Jan 13, 2016 | Substantially Equivalent | FRONTIER MEDICAL DEVICES, INC. |
| K151888 | Frontier Medical Devices In-line Orthopedic Cable Cerclage System | Oct 30, 2015 | Substantially Equivalent | FRONTIER MEDICAL DEVICES, INC. |
| K143716 | DSM Biomedical DPR Cable | Oct 29, 2015 | Substantially Equivalent | DSM BIOMEDICAL |
| K151346 | Frontier Medical Devices Posterior Cable Screw System | Aug 20, 2015 | Substantially Equivalent | FRONTIER MEDICAL DEVICES, INC. |
| K150889 | Suture Wires and Wire Loops | Jul 01, 2015 | Substantially Equivalent | ZIMMER, INC. |
| K150581 | Tritium Sternal Cable Plate System | Jun 04, 2015 | Substantially Equivalent | Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) |
| K133785 | TRITIUM STERNAL CABLE PLATE SYSTEM | Jan 27, 2014 | Substantially Equivalent | PIONEER SURGICAL TECHNOLOGY, INC |
| K133354 | PERI-PROSTHETIC CABLE SYSTEM | Jan 27, 2014 | Substantially Equivalent | BIOMET, INC. |
| K130431 | COMPRESSYN BAND | Jul 25, 2013 | Substantially Equivalent | DALLEN MEDICAL, INC. |
| K121541 | JAZZ SYSTEM | Sep 13, 2012 | Substantially Equivalent | IMPLANET S.A. |
| K120177 | SPINAL ELEMENTS CERCLAGE SYSTEM | Jul 03, 2012 | Substantially Equivalent | SPINAL ELEMENTS, INC. |
| K112736 | PASS LP SPINAL | Feb 01, 2012 | Substantially Equivalent | MEDICREA INTERNATIONAL |
| K110789 | SYNTHES STERNAL ZIPFIX SYSTEM | Jul 28, 2011 | Substantially Equivalent | SYNTHES (USA) |
| K110541 | FIGURE 8 STERNOTOMY CLOSURE DEVICE | Jul 06, 2011 | Substantially Equivalent | FIGURE 8 SURGICAL, INCORPORATED |
| K103797 | K2M COCR WIRE | May 20, 2011 | Substantially Equivalent | K2M, INC. |
| K110039 | BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM | May 03, 2011 | Substantially Equivalent | BIOMET SPORTS MEDICINE |
| K101484 | COMPRESSYN BAND | Apr 01, 2011 | Substantially Equivalent | DALLEN MEDICAL |
| K102834 | ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER) | Jan 12, 2011 | Substantially Equivalent | KINAMED INCORPORATED |
| K090686 | SIC BREVETTI S.R.L. DEVICE FOR STERNAL SYNTHESIS | Dec 08, 2009 | Substantially Equivalent | SIC BREVETTI S.R.L. |
| K091190 | UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063 | Jul 30, 2009 | Substantially Equivalent | ZIMMER SPINE, INC |
| K081622 | UNIVERSAL CLAMP STAINLESS STEEL SYSTEM | Aug 29, 2008 | Substantially Equivalent | ABBOTT SPINE, INC. |
| K081205 | SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS | Jul 01, 2008 | Substantially Equivalent | SYNTHES (USA) |
| K071271 | BIOMET CABLE SYSTEM | Oct 23, 2007 | Substantially Equivalent | BIOMET MANUFACTURING, INC. |
| K063017 | AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM | Dec 27, 2006 | Substantially Equivalent | AESCULAP, INC. |
| K060009 | ABBOTT SPINE UNIVERSAL CLAMP SYSTEM | Mar 06, 2006 | Substantially Equivalent | ABBOTT SPINE, INC. |
| K050041 | SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM | Feb 25, 2005 | Substantially Equivalent | SYNTHES (USA) |
| K043252 | CABLING SYSTEM TROCHANTER HOOK | Jan 14, 2005 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K033816 | SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM | Mar 02, 2004 | Substantially Equivalent | SYNTHES (USA) |
| K040199 | OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS | Feb 20, 2004 | Substantially Equivalent | OSSEUS, LLC |
| K030256 | ISO-ELASTIC CERCLAGE SYSTEM | Oct 21, 2003 | Substantially Equivalent | KINAMED, INC. |
| K031508 | SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM | May 30, 2003 | Substantially Equivalent | SYNTHES (USA) |
| K031162 | SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM | May 01, 2003 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K023564 | OSSE-LIGN | Mar 11, 2003 | Substantially Equivalent | OSSEUS, LLC |
| K010943 | SYNTHES STERNAL FIXATION SYSTEM | Jun 27, 2001 | Substantially Equivalent | SYNTHES (USA) |
| K003951 | PECTOFIX STERNAL REPAIR WIRE | Mar 21, 2001 | Substantially Equivalent | PECTOFIX, INC. |
| K001254 | ORTHOMATRIX, INC. CERCLAGE SYSTEM | Dec 13, 2000 | Substantially Equivalent | ORTHOMATRIX, INC. |
| K002110 | SPL CRIMP SYSTEM | Oct 06, 2000 | Substantially Equivalent | PIONEER SURGICAL TECHNOLOGY |
| K001709 | TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODEL 501-066, 501-067 | Aug 31, 2000 | Substantially Equivalent | PIONEER SURGICAL TECHNOLOGY |
| K000694 | PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF) | May 11, 2000 | Substantially Equivalent | PECTOFIX, INC. |
| K993903 | WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013 | Feb 14, 2000 | Substantially Equivalent | WHITESIDE BIOMECHANICS, INC. |
| K993286 | PIONEER SILICOAT STERNAL CABLE | Nov 23, 1999 | Substantially Equivalent | PIONEER SURGICAL TECHNOLOGY |
| K992891 | SYNTHES CERCLAGE POSITIONING PIN | Nov 02, 1999 | Substantially Equivalent | SYNTHES (USA) |
| K992616 | SDB CERCLAGE SYSTEM | Oct 27, 1999 | Substantially Equivalent | PIONEER SURGICAL TECHNOLOGY |
| K984432 | DALL-MILES CABLE GRIP (A-GRIP) | Feb 24, 1999 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K983976 | METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM | Dec 30, 1998 | Substantially Equivalent | METAGEN, L.L.C. |
| K982545 | BMP CABLE SYSTEM | Oct 19, 1998 | Substantially Equivalent | BIOMET, INC. |
| K980690 | CABLE SCREW WITH INTEGRAL CRIMP | May 22, 1998 | Substantially Equivalent | PIONEER SURGICAL TECHNOLOGY |
| K974020 | SPINAL CONCEPTS, INC., CFIX CABLE SYSTEM | Dec 19, 1997 | Substantially Equivalent | SPINAL CONCEPTS, INC. |
| K974016 | CERCLAGE CABLE WITH HEX BUTTON | Dec 19, 1997 | Substantially Equivalent | PIONEER SURGICAL TECHNOLOGY |
| K973098 | COMPRESSION CERCLAGE GUNDOLF CCG-GF | Oct 27, 1997 | Substantially Equivalent | PLUS ORTHOPEDICS |
| K972327 | METAGEN ACTIVELOCK CERCLAGE SYSTEM | Aug 11, 1997 | Substantially Equivalent | PACIFIC MATERIALS AND INTERFACES |
| K971741 | DALL-MILES HOMOGENEOUS STAINLESS STEEL CABLE AND BEADED CABLE | Jul 16, 1997 | Substantially Equivalent | HOWMEDICA CORP. |
| K970084 | LINK CERCLAGE WIRE SYSTEM | Mar 13, 1997 | Substantially Equivalent | TURNKEY INTERGRATION USA, INC. |
| K962162 | DALL-MILES TROCHANTER CABLE SUPERGRIP | Aug 14, 1996 | Substantially Equivalent | HOWMEDICA CORP. |
| K962132 | SILKON STAINLESS STEEL CABLE SYSTEM | Aug 08, 1996 | Substantially Equivalent | OSTEONICS CORP. |
| K961267 | PIONEER SYSTEM GTR(GREATER TROCHANTEER REATTACHMENT) DEVICE | Jun 27, 1996 | Substantially Equivalent | PIONEER SURGICAL TECHNOLOGY |
| K961569 | DALL-MILES STAINLESS STEEL BEADED CABLE | Jun 24, 1996 | Substantially Equivalent | HOWMEDICA CORP. |
| K961283 | DALL-MILES HOMOGENOUS VITALLIUM CABLE | May 22, 1996 | Substantially Equivalent | HOWMEDICA CORP. |
| K960651 | CERCLAGE WIRE CRIMP BLOCK | May 03, 1996 | Substantially Equivalent | ACU-MED, INC. |
| K953777 | SYNTHES WIRE MOUNT | Mar 08, 1996 | Substantially Equivalent | SYNTHES (USA) |
| K953818 | DALL-MILES SUTURE/BEADED CABLE | Oct 12, 1995 | Substantially Equivalent | HOWMEDICA CORP. |
| K951844 | BIOMECHANIC LOW-PROFILE CABLE SYSTEM | Jul 13, 1995 | Substantially Equivalent for Some Indications | BIOMECHANIC, INC. |
| K945294 | DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLE | Mar 07, 1995 | Substantially Equivalent for Some Indications | HOWMEDICA CORP. |
| K950027 | CABLE-EASE PLATE AND CABLE SYSTEM - TROCHANTERIC HOOK | Mar 06, 1995 | Substantially Equivalent for Some Indications | INTERMEDICS ORTHOPEDICS |
| K944529 | CABLE-EASE PLATE AND CABLE SYSTEM | Feb 17, 1995 | Substantially Equivalent for Some Indications | INTERMEDICS ORTHOPEDICS |
| K932024 | CCG CERCLAGE SYSTEM | Feb 14, 1995 | Substantially Equivalent for Some Indications | ENCORE ORTHOPEDICS, INC. |
| K942300 | SILKON TITANIUM CABLE SYSTEM | Jan 09, 1995 | Unknown | AMERICAN MEDICAL ELECTRONICS, INC. |
| K940729 | PIONEER LABORATORIES BONE PLATE WITH CERCLAGE CABLES | Dec 21, 1994 | Substantially Equivalent | PIONEER SURGICAL TECHNOLOGY |
| K934059 | DALL MILES SYSTEM GROOVED BUTTON | Aug 01, 1994 | Substantially Equivalent for Some Indications | HOWMEDICA CORP. |
| K932687 | AME(R) UNIVERSIAL CABLE SYSTEM | May 03, 1994 | Substantially Equivalent | AMERICAN MEDICAL ELECTRONICS, INC. |
| K941213 | SONGER CABLE SYSTEM | Apr 19, 1994 | Substantially Equivalent for Some Indications | PIONEER SURGICAL TECHNOLOGY |
| K935950 | FX-CABLELOK CABLE/PLATE SYSTEM | Mar 09, 1994 | Substantially Equivalent for Some Indications | BUCKMAN CO., INC. |
| K935646 | FX-CABLELOK(TM) STOP(TROCHANTER HOOK) SYSTEM | Mar 09, 1994 | Substantially Equivalent for Some Indications | BIODYNAMIC TECHNOLOGIES, INC. |
| K934557 | CONTROL CABLE SYSTEM | Feb 25, 1994 | Substantially Equivalent | DEPUY, INC. |
| K934058 | DALL MILES SYSTEM MINICLEAT | Feb 23, 1994 | Substantially Equivalent for Some Indications | HOWMEDICA CORP. |
| K934176 | SURGICAL ACCESSORIES LOOPED WIRE | Feb 22, 1994 | Substantially Equivalent | SURGICAL ACCESSORIES, INC. |
| K931246 | CERCLAGE WIRE CRIMP SLEEVE | Feb 22, 1994 | Substantially Equivalent | ACUMED, INC. |
| K935592 | SURGICAL ACCESSORIES COCR CABLE SYSTEM | Jan 26, 1994 | Substantially Equivalent | SURGICAL ACCESSORIES, INC. |
| K935481 | SPONGER CABLE SYSTEM, MODIFICATION | Jan 26, 1994 | Substantially Equivalent | PIONEER SURGICAL TECHNOLOGY |
| K924141 | ORTHOPAEDIC POLYETHYLENE CABLE | Nov 30, 1993 | Substantially Equivalent | SMITH & NEPHEW RICHARDS, INC. |
| K925447 | OTI ORTHOPEDIC WIRE SYSTEM | Jun 29, 1993 | Substantially Equivalent | OSTEO TECHNOLOGY, INC. |
| K930015 | STERNAL BAND | May 19, 1993 | Substantially Equivalent | STONY BROOK SURGICAL INNOVATIONS, INC. |
| K923869 | CODMAN SOF'WIRE TITANIUM CABLE SYSTEM | May 12, 1993 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K926116 | CODMAN SOFWIRE(TM) KIT | Mar 30, 1993 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K925812 | TITANIUM SONGER CABLE SYSTEM | Mar 24, 1993 | Substantially Equivalent | SOFAMOR DANEK MFG., INC. |
| K922952 | SONGER CABLE SYSTEM | Feb 23, 1993 | Substantially Equivalent | PIONEER SURGICAL TECHNOLOGY |
| K922142 | FX-CABLELOK SYSTEM | Nov 20, 1992 | Substantially Equivalent | BIO-TECH CO. |
| K921480 | OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM | Jun 26, 1992 | Substantially Equivalent | ACU-MED, INC. |
| K920201 | TITANIUM ALLOY SONGER CABLE SYSTEM | Apr 08, 1992 | Substantially Equivalent for Some Indications | SOFAMOR DANEK MFG., INC. |
| K915259 | FX-CABLELOK SYSTEM, MODIFICATION | Feb 07, 1992 | Substantially Equivalent | BIODYNAMIC TECHNOLOGIES, INC. |
| K915581 | CODMAN SOF'WIRE (TM) KIT | Jan 16, 1992 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K914374 | OSTEO CERCLAGE WIRE | Dec 30, 1991 | Substantially Equivalent | OSTEO AG |
| K914693 | DEPUY (NITINO) GUIDE WIRE | Dec 09, 1991 | Substantially Equivalent | DEPUY, INC. |
| K913735 | SONGER(TM) CABLE SYSTEM | Nov 18, 1991 | Substantially Equivalent | DANEK MEDICAL, INC. |
| K912207 | FX-CABLELOK SYSTEM | Jul 09, 1991 | Substantially Equivalent | BIODYNAMIC TECHNOLOGIES, INC. |
| K910128 | LEVTECH TITANIUM BONE WIRE | Jun 18, 1991 | Substantially Equivalent | LEVTECH, INC. |
| K903676 | STERNOTOMY CABLE, SONGER CABLE SYSTEM | Sep 10, 1990 | Substantially Equivalent | DANEK MEDICAL, INC. |
| K892411 | MENNEN BONE FIXATION DEVICE | Jan 05, 1990 | Substantially Equivalent | DENTSPLY INTL. |
| K882967 | BONE FIXATION WIRE | Sep 30, 1988 | Substantially Equivalent | BAXTER HEALTHCARE CORP. |
| K882890 | WROBLEWSKI SPRING COMPRESSION WIRE SYSTEM | Aug 08, 1988 | Substantially Equivalent | THACKRAY USA |
| K880309 | TYPE 316L STAINLESS STEEL WIRE | Feb 29, 1988 | Substantially Equivalent | WINN HIRSCH & ASSOC. |
| K875156 | STAINLESS STEEL ORTHOPAEDIC CABLE SYSTEM | Jan 20, 1988 | Substantially Equivalent | RICHARDS MEDICAL CO., INC. |
| K874919 | ORTHOMET WIRE FOR SUTURE, CERCLAGE | Jan 07, 1988 | Substantially Equivalent | ORTHOMET, INC. |
| K850631 | KIRSCHNER ORTHOPEDIC WIRE, EYELET CERCLAGE WIRES | May 01, 1985 | Substantially Equivalent | KIRSCHNER MEDICAL CORP. |
| K842977 | ORTHOPAEDIC CABLE SYSTEM | Oct 26, 1984 | Substantially Equivalent | RICHARDS MEDICAL CO., INC. |
FEI Numbers
This FDA classification entry is associated with 153 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 153 registration numbers. Click on an entry to view related FDA registrations.