Cerclage, Fixation
FDA product code JDQ · Class II (moderate risk) · 21 CFR 888.3010 · Orthopedic
130510(k) clearances
0PMA approvals
15recalls
Implantimplanted device
Manufacturers
- Pioneer Surgical Technology 13
- Synthes (Usa) 8
- Howmedica Corp. 8
- Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) 4
- A & E Medical Corporation 4
- Smith & Nephew, Inc. 3
- Frontier Medical Devices, Inc. 3
- Kinamed, Inc. 3
- Biodynamic Technologies, Inc. 3
- Arthrex, Inc. 3
- Codman & Shurtleff, Inc. 3
- Acu Med, Inc. 3
- Depuy, Inc. 2
- Surgical Accessories, Inc. 2
- American Medical Electronics, Inc. 2
- Sofamor Danek Mfg., Inc. 2
- Biomet, Inc. 2
- Pectofix, Inc. 2
- Abbott Spine, Inc. 2
- Dallen Medical, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261271 | Cable-Ready® Cable Grip SystemJDQ · Traditional | Pioneer Surgical Technology, Inc. | 07/16/2026SE |
| K243905 | Stitch Cerclage Suture TapesJDQ · Traditional | GM Dos Reis Industria e Comercio Ltda. | 08/14/2025SE |
| K243344 | Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…JDQ · Traditional | Arthrex, Inc. | 02/20/2025SE |
| K232733 | Mbrace CableJDQ · Traditional | Medacta International S.A. | 05/03/2024SE |
| K233949 | ACCORD Cable SystemJDQ · Traditional | Smith & Nephew, Inc. | 03/13/2024SE |
| K232986 | VariTrax Sternal CircumFixation SystemJDQ · Traditional | Circumfix Solutions, Inc. | 01/30/2024SE |
| K230976 | Arthrex Radiopaque FiberTape Cerclage suturesJDQ · Traditional | Arthrex, Inc. | 08/24/2023SE |
| K231333 | STRETTO Cable SystemJDQ · Traditional | Globus Medical, Inc. | 08/04/2023SE |
| K220765 | HS Fiber CerclageJDQ · Traditional | Riverpoint Medical, LLC | 07/26/2023SE |
| K221795 | STERN FIX Sternal Stabilization SystemJDQ · Traditional | Neos Surgery S.L | 10/19/2022SE |
| K211613 | Stern Fix Sternal Stabilization SystemJDQ · Traditional | Neos Surgery S.L | 01/19/2022SE |
| K201497 | EVOS Cabling SystemJDQ · Traditional | Pioneer Surgical Technology, Inc. (Dba Rti… | 10/28/2020SE |
| K202016 | Dall-Miles® Cable SystemJDQ · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 10/16/2020SE |
| K193479 | Sternal Cable SystemJDQ · Traditional | A & E Medical Corporation | 03/23/2020SE |
| K193468 | Tritium Sternal Cable Plate SystemJDQ · Traditional | Pioneer Surgical Technology, Inc. (Dba Rti… | 03/12/2020SE |
| K181607 | Thorecon Rigid Fixation SystemJDQ · Traditional | A & E Medical Corporation | 10/12/2018SE |
| K173910 | Impress SFS SystemJDQ · Traditional | Cable Fix Medical, LLC | 09/14/2018SE |
| K181749 | SuperCable® Iso-Elastic Cerclage SystemJDQ · Special | Kinamed, Incorporated | 08/01/2018SE |
| K172975 | DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins MR Conditional, DePuy Synthes…JDQ · Traditional | Synthes (Usa) Products, LLC / Depuy… | 06/21/2018SE |
| K180582 | Sternal Cable SystemJDQ · Traditional | A & E Medical Corporation | 05/31/2018SE |
| K173579 | Thorecon Fixation SystemJDQ · Traditional | A & E Medical Corporation | 02/12/2018SE |
| K170206 | Arthrex FiberTape CerclageJDQ · Traditional | Arthrex, Inc. | 11/15/2017SE |
| K161876 | Tritium® Sternal Cable Plate SystemJDQ · Special | Pioneer Surgical Technology, Inc., Dba Rti… | 09/09/2016SE |
| K151983 | KLS Martin LSS Plating SystemJDQ · Traditional | KLS Martin L.P. | 04/06/2016SE |
| K151848 | Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemJDQ · Traditional | Zimmer, Inc. | 01/15/2016SE |
| K153242 | Frontier Medical Devices In-Line Orthopedic Cable Cerclage SystemJDQ · Traditional | Frontier Medical Devices, Inc. | 01/13/2016SE |
| K151888 | Frontier Medical Devices In-line Orthopedic Cable Cerclage SystemJDQ · Traditional | Frontier Medical Devices, Inc. | 10/30/2015SE |
| K143716 | DSM Biomedical DPR CableJDQ · Traditional | Dsm Biomedical | 10/29/2015SE |
| K151346 | Frontier Medical Devices Posterior Cable Screw SystemJDQ · Traditional | Frontier Medical Devices, Inc. | 08/20/2015SE |
| K150889 | Suture Wires and Wire LoopsJDQ · Traditional | Zimmer, Inc. | 07/01/2015SE |
| K150581 | Tritium Sternal Cable Plate SystemJDQ · Traditional | Pioneer Surgical Technology, Inc. (Dba Rti… | 06/04/2015SE |
| K133785 | Tritium Sternal Cable Plate SystemJDQ · Traditional | Pioneer Surgical Technology, Inc. | 01/27/2014SE |
| K133354 | Peri-Prosthetic Cable SystemJDQ · Traditional | Biomet, Inc. | 01/27/2014SE |
| K130431 | Compressyn BandJDQ · Traditional | Dallen Medical, Inc. | 07/25/2013SE |
| K121541 | Jazz SystemJDQ · Traditional | Implanet, S.A. | 09/13/2012SE |
| K120177 | Spinal Elements Cerclage SystemJDQ · Traditional | Spinal Elements, Inc. | 07/03/2012SE |
| K112736 | Pass LP SpinalJDQ · Traditional | Medicrea International | 02/01/2012SE |
| K110789 | Synthes Sternal Zipfix SystemJDQ · Traditional | Synthes (Usa) | 07/28/2011SE |
| K110541 | Figure 8 Sternotomy Closure DeviceJDQ · Traditional | Figure 8 Surgical, Incorporated | 07/06/2011SE |
| K103797 | K2M Cocr WireJDQ · Traditional | K2m, Inc. | 05/20/2011SE |
| K110039 | Biomet Sports Medicine Sternal Closure SystemJDQ · Traditional | Biomet Sports Medicine | 05/03/2011SE |
| K101484 | Compressyn BandJDQ · Traditional | Dallen Medical | 04/01/2011SE |
| K102834 | Iso-Elastic Cerclage System (1MM and 2MM Cable Diameter)JDQ · Special | Kinamed, Incorporated | 01/12/2011SE |
| K090686 | Sic Brevetti S.R.L. Device for Sternal SynthesisJDQ · Traditional | Sic Brevetti S.R.L. | 12/08/2009SE |
| K091190 | Universal Clamp Stainless Steel System, Models SNA027-0-30060, SNA027-0-30063JDQ · Special | Zimmer Spine, Inc. | 07/30/2009SE |
| K081622 | Universal Clamp Stainless Steel SystemJDQ · Special | Abbott Spine, Inc. | 08/29/2008SE |
| K081205 | Synthes (USA) 5.0MM/7.3MM Crimp Positioning PinsJDQ · Traditional | Synthes (Usa) | 07/01/2008SE |
| K071271 | Biomet Cable SystemJDQ · Traditional | Biomet Manufacturing, Inc. | 10/23/2007SE |
| K063017 | Aesculap Sternumfix Sternal Closure SystemJDQ · Traditional | Aesculap, Inc. | 12/27/2006SE |
| K060009 | Abbott Spine Universal Clamp SystemJDQ · Special | Abbott Spine, Inc. | 03/06/2006SE |
| K050041 | Synthes (USA) Sterile Sternal Fixation SystemJDQ · Traditional | Synthes (Usa) | 02/25/2005SE |
| K043252 | Cabling System Trochanter HookJDQ · Traditional | Smith & Nephew, Inc. | 01/14/2005SE |
| K033816 | Synthes (USA) Modification to Sternal Reconstruction SystemJDQ · Traditional | Synthes (Usa) | 03/02/2004SE |
| K040199 | Osse-Lign, 1.5MM Cocr and SS Cable System and ComponentsJDQ · Special | Osseus, LLC | 02/20/2004SE |
| K030256 | Iso-Elastic Cerclage SystemJDQ · Traditional | Kinamed, Inc. | 10/21/2003SE |
| K031508 | Synthes (USA) Sternal Reconstruction SystemJDQ · Traditional | Synthes (Usa) | 05/30/2003SE |
| K031162 | Smith & Nephew Orthopaedic Cabling SystemJDQ · Special | Smith & Nephew, Inc. | 05/01/2003SE |
| K023564 | Osse-LignJDQ · Traditional | Osseus, LLC | 03/11/2003SE |
| K010943 | Synthes Sternal Fixation SystemJDQ · Abbreviated | Synthes (Usa) | 06/27/2001SE |
| K003951 | Pectofix Sternal Repair WireJDQ · Traditional | Pectofix, Inc. | 03/21/2001SE |
| K001254 | Orthomatrix, Inc. Cerclage SystemJDQ · Traditional | Orthomatrix, Inc. | 12/13/2000SE |
| K002110 | SPL Crimp SystemJDQ · Traditional | Pioneer Surgical Technology | 10/06/2000SE |
| K001709 | Trochanteric Reattachment Device (Standard) and (Long), Model 501-066, 501-067JDQ · Traditional | Pioneer Surgical Technology | 08/31/2000SE |
| K000694 | Pectofix Dynamic Sternal Fixation System (DSF)JDQ · Traditional | Pectofix, Inc. | 05/11/2000SE |
| K993903 | Whiteside Biomechanics Titanium Low-Profile Cable, Model BIO-1-1013JDQ · Traditional | Whiteside Biomechanics, Inc. | 02/14/2000SE |
| K993286 | Pioneer Silicoat Sternal CableJDQ · Special | Pioneer Surgical Technology | 11/23/1999SE |
| K992891 | Synthes Cerclage Positioning PinJDQ · Traditional | Synthes (Usa) | 11/02/1999SE |
| K992616 | SDB Cerclage SystemJDQ · Traditional | Pioneer Surgical Technology | 10/27/1999SE |
| K984432 | Dall-Miles Cable Grip (A-Grip)JDQ · Traditional | Howmedica Osteonics Corp. | 02/24/1999SE |
| K983976 | Metagen Activelock Wire Cerclage SystemJDQ · Traditional | Metagen, LLC | 12/30/1998SE |
| K982545 | BMP Cable SystemJDQ · Traditional | Biomet, Inc. | 10/19/1998SE |
| K980690 | Cable Screw with Integral CrimpJDQ · Traditional | Pioneer Surgical Technology | 05/22/1998SE |
| K974020 | Spinal Concepts, Inc., Cfix Cable SystemJDQ · Traditional | Spinal Concepts, Inc. | 12/19/1997SE |
| K974016 | Cerclage Cable with Hex ButtonJDQ · Traditional | Pioneer Surgical Technology | 12/19/1997SE |
| K973098 | Compression Cerclage Gundolf Ccg-GfJDQ · Traditional | Plus Orthopedics | 10/27/1997SE |
| K972327 | Metagen Activelock Cerclage SystemJDQ · Traditional | Pacific Materials and Interfaces | 08/11/1997SE |
| K971741 | Dall-Miles Homogeneous Stainless Steel Cable and Beaded CableJDQ · Traditional | Howmedica Corp. | 07/16/1997SE |
| K970084 | Link Cerclage Wire SystemJDQ · Traditional | Turnkey Intergration USA, Inc. | 03/13/1997SE |
| K962162 | Dall-Miles Trochanter Cable SupergripJDQ · Traditional | Howmedica Corp. | 08/14/1996SE |
| K962132 | Silkon Stainless Steel Cable SystemJDQ · Traditional | Osteonics Corp. | 08/08/1996SE |
| K961267 | Pioneer System Gtr(Greater Trochanteer Reattachment) DeviceJDQ · Traditional | Pioneer Surgical Technology | 06/27/1996SE |
| K961569 | Dall-Miles Stainless Steel Beaded CableJDQ · Traditional | Howmedica Corp. | 06/24/1996SE |
| K961283 | Dall-Miles Homogenous Vitallium CableJDQ · Traditional | Howmedica Corp. | 05/22/1996SE |
| K960651 | Cerclage Wire Crimp BlockJDQ · Traditional | Acu-Med, Inc. | 05/03/1996SE |
| K953777 | Synthes Wire MountJDQ · Traditional | Synthes (Usa) | 03/08/1996SE |
| K953818 | Dall-Miles Suture/Beaded CableJDQ · Traditional | Howmedica Corp. | 10/12/1995SE |
| K951844 | Biomechanic Low-Profile Cable SystemJDQ · Traditional | Biomechanic, Inc. | 07/13/1995SN |
| K945294 | Dall Miles System Homogeneous Vitallium CableJDQ · Traditional | Howmedica Corp. | 03/07/1995SN |
| K950027 | Cable-Ease Plate and Cable System - Trochanteric HookJDQ · Traditional | Intermedics Orthopedics | 03/06/1995SN |
| K944529 | Cable-Ease Plate and Cable SystemJDQ · Traditional | Intermedics Orthopedics | 02/17/1995SN |
| K932024 | CCG Cerclage SystemJDQ · Traditional | Encore Orthopedics, Inc. | 02/14/1995SN |
| K942300 | Silkon Titanium Cable SystemJDQ · Traditional | American Medical Electronics, Inc. | 01/09/1995SESK |
| K940729 | Pioneer Laboratories Bone Plate with Cerclage CablesJDQ · Traditional | Pioneer Surgical Technology | 12/21/1994SE |
| K934059 | Dall Miles System Grooved ButtonJDQ · Traditional | Howmedica Corp. | 08/01/1994SN |
| K932687 | Ame(R) Universial Cable SystemJDQ · Traditional | American Medical Electronics, Inc. | 05/03/1994SE |
| K941213 | Songer Cable SystemJDQ · Traditional | Pioneer Surgical Technology | 04/19/1994SN |
| K935950 | Fx-Cablelok Cable/Plate SystemJDQ · Traditional | Buckman Co., Inc. | 03/09/1994SN |
| K935646 | Fx-Cablelok(Tm) Stop(Trochanter Hook) SystemJDQ · Traditional | Biodynamic Technologies, Inc. | 03/09/1994SN |
| K934557 | Control Cable SystemJDQ · Traditional | Depuy, Inc. | 02/25/1994SE |
| K934058 | Dall Miles System MinicleatJDQ · Traditional | Howmedica Corp. | 02/23/1994SN |
| K934176 | Surgical Accessories Looped WireJDQ · Traditional | Surgical Accessories, Inc. | 02/22/1994SE |
| K931246 | Cerclage Wire Crimp SleeveJDQ · Traditional | Acu Med, Inc. | 02/22/1994SE |
| K935592 | Surgical Accessories Cocr Cable SystemJDQ · Traditional | Surgical Accessories, Inc. | 01/26/1994SE |
| K935481 | Sponger Cable System, ModificationJDQ · Traditional | Pioneer Surgical Technology | 01/26/1994SE |
| K924141 | Orthopaedic Polyethylene CableJDQ · Traditional | Smith & Nephew Richards, Inc. | 11/30/1993SE |
| K925447 | Oti Orthopedic Wire SystemJDQ · Traditional | Osteo Technology, Inc. | 06/29/1993SE |
| K930015 | Sternal BandJDQ · Traditional | Stony Brook Surgical Innovations, Inc. | 05/19/1993SE |
| K923869 | Codman Sof'Wire Titanium Cable SystemJDQ · Traditional | Codman & Shurtleff, Inc. | 05/12/1993SE |
| K926116 | Codman Sofwire(Tm) KitJDQ · Traditional | Codman & Shurtleff, Inc. | 03/30/1993SE |
| K925812 | Titanium Songer Cable SystemJDQ · Traditional | Sofamor Danek Mfg., Inc. | 03/24/1993SE |
| K922952 | Songer Cable SystemJDQ · Traditional | Pioneer Surgical Technology | 02/23/1993SE |
| K922142 | Fx-Cablelok SystemJDQ · Traditional | Bio-Tech Co. | 11/20/1992SE |
| K921480 | Osteo-Clage(Tm) Cerciage Cable SystemJDQ · Traditional | Acu-Med, Inc. | 06/26/1992SE |
| K920201 | Titanium Alloy Songer Cable SystemJDQ · Traditional | Sofamor Danek Mfg., Inc. | 04/08/1992SN |
| K915259 | Fx-Cablelok System, ModificationJDQ · Traditional | Biodynamic Technologies, Inc. | 02/07/1992SE |
| K915581 | Codman Sof'Wire (TM) KitJDQ · Traditional | Codman & Shurtleff, Inc. | 01/16/1992SE |
| K914374 | Osteo Cerclage WireJDQ · Traditional | Osteo AG | 12/30/1991SE |
| K914693 | Depuy (Nitino) Guide WireJDQ · Traditional | Depuy, Inc. | 12/09/1991SE |
| K913735 | Songer(Tm) Cable SystemJDQ · Traditional | Danek Medical, Inc. | 11/18/1991SE |
| K912207 | Fx-Cablelok SystemJDQ · Traditional | Biodynamic Technologies, Inc. | 07/09/1991SE |
| K910128 | Levtech Titanium Bone WireJDQ · Traditional | Levtech, Inc. | 06/18/1991SE |
| K903676 | Sternotomy Cable, Songer Cable SystemJDQ · Traditional | Danek Medical, Inc. | 09/10/1990SE |
| K892411 | Mennen Bone Fixation DeviceJDQ · Traditional | Dentsply Intl. | 01/05/1990SE |
| K882967 | Bone Fixation WireJDQ · Traditional | Baxter Healthcare Corp | 09/30/1988SE |
| K882890 | Wroblewski Spring Compression Wire SystemJDQ · Traditional | Thackray USA | 08/08/1988SE |
| K880309 | Type 316L Stainless Steel WireJDQ · Traditional | Winn Hirsch & Assoc. | 02/29/1988SE |
| K875156 | Stainless Steel Orthopaedic Cable SystemJDQ · Traditional | Richards Medical Co., Inc. | 01/20/1988SE |
| K874919 | Orthomet Wire for Suture, CerclageJDQ · Traditional | Orthomet, Inc. | 01/07/1988SE |
| K850631 | Kirschner Orthopedic Wire, Eyelet Cerclage WiresJDQ · Traditional | Kirschner Medical Corp. | 05/01/1985SE |
| K842977 | Orthopaedic Cable SystemJDQ · Traditional | Richards Medical Co., Inc. | 10/26/1984SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0246-2020 Class II | A&E Medical Thorecon Plating System Kits Model No. 94-1700-10. For fracture fixation or…Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which… | Alto Development Corp | 09/10/2019Terminated |
| Z-0245-2020 Class II | A&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For fracture fixation…Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which… | Alto Development Corp | 09/10/2019Terminated |
| Z-0244-2020 Class II | A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fixation or…Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which… | Alto Development Corp | 09/10/2019Terminated |
| Z-0243-2020 Class II | A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation…Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which… | Alto Development Corp | 09/10/2019Terminated |
| Z-0242-2020 Class II | A&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture fixation or…Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which… | Alto Development Corp | 09/10/2019Terminated |
| Z-0276-2016 Class II | Synthes Application Instrument for Sternal ZIPFIX. Indications for use include primary…Certain lots of the Application Instrument for Sternal ZIPFIX that were previously recalled on August 19… | Synthes (USA) Products LLC | 10/19/2015Terminated |
| Z-2475-2015 Class II | Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary…The end cap may loosen and detach making the instrument non-functional. No injuries reported. | Synthes (USA) Products LLC | 07/22/2015Terminated |
| Z-2053-2015 Class II | Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile. The…The box end label is incorrectly labeled as Titanium instead of Stainless Steel on one lot of implantable… | RTI Surgical, Inc. (dba Pioneer Surgical… | 05/29/2015Terminated |
| Z-2246-2015 Class II | Medical Device Exchange 3.5mm Threaded Cerclage Pin; Pouch, Tyvek/Mylar, Sterile, Single…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | EXP Pharmaceutical Services Corp | 02/11/2015Terminated |
| Z-2076-2014 Class II | Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. The Pioneer…Lack of Sterility Assurance | Pioneer Surgical Technology, Inc. | 06/11/2014Terminated |
| Z-0114-2014 Class II | Synthes Application Instrument Sternal Zip Flex System intended for use in primary or…When using the 1st generation Zip Fix Application Instrument it is possible to cut the implant while the… | Synthes USA HQ, Inc. | 08/13/2013Terminated |
| Z-2198-2010 | CERCLAGE WIRE, 0.8 MM DIA. X 200 MM LENGTH, SST, REF 71163008, QTY: (6), STERILE R, CE…Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single… | Smith & Nephew Inc | 06/28/2010Terminated |
| Z-2197-2010 | CERCLAGE WIRE, 0.6 MM DIA. X 175 MM LENGTH, SST, REF 71163006, QTY: (6), STERILE R, CE…Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single… | Smith & Nephew Inc | 06/28/2010Terminated |
| Z-0288-2009 | Biomet 2.0 MM Stainless Steel (SS) Crimp Sleeve, sterile, use w/2.0 MM S.S. cable #…The outer package is properly labeled, but the inner package may be labeled as a femoral component. | Biomet, Inc. | 09/24/2008Terminated |
| Z-2140-2008 | Osteo-Clage Cable System Package Assembly (01-0001-S). Product labeled in part, "2.0mm x…Cables of incorrect diameter were used in product assembly, resulting in the sleeve not being able to bind… | Acumed LLC | 03/28/2008Terminated |