JDQ · Cerclage, Fixation
Orthopedic · 21 CFR 888.3010 · Class 2
Overview
| Product Code | JDQ |
|---|---|
| Device Name | Cerclage, Fixation |
| Regulation | 21 CFR 888.3010 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.
Classification Rationale
Class II.
Cleared Devices (129)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243905 | Stitch Cerclage Suture Tapes | GM Dos Reis Industria e Comercio Ltda. | Aug 14, 2025 | SESE |
| K243344 | Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures | Arthrex, Inc. | Feb 20, 2025 | SESE |
| K232733 | Mbrace Cable | Medacta International S.A. | May 3, 2024 | SESE |
| K233949 | ACCORD Cable System | Smith & Nephew, Inc. | Mar 13, 2024 | SESE |
| K232986 | VariTrax Sternal CircumFixation System | Circumfix Solutions, Inc. | Jan 30, 2024 | SESE |
| K230976 | Arthrex Radiopaque FiberTape Cerclage sutures | Arthrex, Inc. | Aug 24, 2023 | SESE |
| K231333 | STRETTO Cable System | Globus Medical, Inc. | Aug 4, 2023 | SESE |
| K220765 | HS Fiber Cerclage | Riverpoint Medical, LLC | Jul 26, 2023 | SESE |
| K221795 | STERN FIX Sternal Stabilization System | Neos Surgery S.L | Oct 19, 2022 | SESE |
| K211613 | Stern Fix Sternal Stabilization System | Neos Surgery S.L | Jan 19, 2022 | SESE |
| K201497 | EVOS Cabling System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | Oct 28, 2020 | SESE |
| K202016 | Dall-Miles® Cable System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Oct 16, 2020 | SESE |
| K193479 | Sternal Cable System | A & E Medical Corporation | Mar 23, 2020 | SESE |
| K193468 | Tritium Sternal Cable Plate System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | Mar 12, 2020 | SESE |
| K181607 | Thorecon Rigid Fixation System | A & E Medical Corporation | Oct 12, 2018 | SESE |
| K173910 | Impress SFS System | Cable Fix Medical, LLC | Sep 14, 2018 | SESE |
| K181749 | SuperCable® Iso-Elastic Cerclage System | Kinamed, Incorporated | Aug 1, 2018 | SESE |
| 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 | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | Jun 21, 2018 | SESE |
| K180582 | Sternal Cable System | A & E Medical Corporation | May 31, 2018 | SESE |
| K173579 | Thorecon Fixation System | A & E Medical Corporation | Feb 12, 2018 | SESE |
| K170206 | Arthrex FiberTape Cerclage | Arthrex, Inc. | Nov 15, 2017 | SESE |
| K161876 | Tritium® Sternal Cable Plate System | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | Sep 9, 2016 | SESE |
| K151983 | KLS Martin LSS Plating System | KLS Martin L.P. | Apr 6, 2016 | SESE |
| K151848 | Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System | Zimmer, Inc. | Jan 15, 2016 | SESE |
| K153242 | Frontier Medical Devices In-Line Orthopedic Cable Cerclage System | Frontier Medical Devices, Inc. | Jan 13, 2016 | SESE |
| K151888 | Frontier Medical Devices In-line Orthopedic Cable Cerclage System | Frontier Medical Devices, Inc. | Oct 30, 2015 | SESE |
| K143716 | DSM Biomedical DPR Cable | Dsm Biomedical | Oct 29, 2015 | SESE |
| K151346 | Frontier Medical Devices Posterior Cable Screw System | Frontier Medical Devices, Inc. | Aug 20, 2015 | SESE |
| K150889 | Suture Wires and Wire Loops | Zimmer, Inc. | Jul 1, 2015 | SESE |
| K150581 | Tritium Sternal Cable Plate System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | Jun 4, 2015 | SESE |
| K133785 | TRITIUM STERNAL CABLE PLATE SYSTEM | Pioneer Surgical Technology, Inc. | Jan 27, 2014 | SESE |
| K133354 | PERI-PROSTHETIC CABLE SYSTEM | Biomet, Inc. | Jan 27, 2014 | SESE |
| K130431 | COMPRESSYN BAND | Dallen Medical, Inc. | Jul 25, 2013 | SESE |
| K121541 | JAZZ SYSTEM | Implanet, S.A. | Sep 13, 2012 | SESE |
| K120177 | SPINAL ELEMENTS CERCLAGE SYSTEM | Spinal Elements, Inc. | Jul 3, 2012 | SESE |
| K112736 | PASS LP SPINAL | Medicrea International | Feb 1, 2012 | SESE |
| K110789 | SYNTHES STERNAL ZIPFIX SYSTEM | Synthes (Usa) | Jul 28, 2011 | SESE |
| K110541 | FIGURE 8 STERNOTOMY CLOSURE DEVICE | Figure 8 Surgical, Incorporated | Jul 6, 2011 | SESE |
| K103797 | K2M COCR WIRE | K2m, Inc. | May 20, 2011 | SESE |
| K110039 | BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM | Biomet Sports Medicine | May 3, 2011 | SESE |
| K101484 | COMPRESSYN BAND | Dallen Medical | Apr 1, 2011 | SESE |
| K102834 | ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER) | Kinamed, Incorporated | Jan 12, 2011 | SESE |
| K090686 | SIC BREVETTI S.R.L. DEVICE FOR STERNAL SYNTHESIS | Sic Brevetti S.R.L. | Dec 8, 2009 | SESE |
| K091190 | UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063 | Zimmer Spine, Inc. | Jul 30, 2009 | SESE |
| K081622 | UNIVERSAL CLAMP STAINLESS STEEL SYSTEM | Abbott Spine, Inc. | Aug 29, 2008 | SESE |
| K081205 | SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS | Synthes (Usa) | Jul 1, 2008 | SESE |
| K071271 | BIOMET CABLE SYSTEM | Biomet Manufacturing, Inc. | Oct 23, 2007 | SESE |
| K063017 | AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM | Aesculap, Inc. | Dec 27, 2006 | SESE |
| K060009 | ABBOTT SPINE UNIVERSAL CLAMP SYSTEM | Abbott Spine, Inc. | Mar 6, 2006 | SESE |
| K050041 | SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM | Synthes (Usa) | Feb 25, 2005 | SESE |
| K043252 | CABLING SYSTEM TROCHANTER HOOK | Smith & Nephew, Inc. | Jan 14, 2005 | SESE |
| K033816 | SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM | Synthes (Usa) | Mar 2, 2004 | SESE |
| K040199 | OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS | Osseus, LLC | Feb 20, 2004 | SESE |
| K030256 | ISO-ELASTIC CERCLAGE SYSTEM | Kinamed, Inc. | Oct 21, 2003 | SESE |
| K031508 | SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM | Synthes (Usa) | May 30, 2003 | SESE |
| K031162 | SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM | Smith & Nephew, Inc. | May 1, 2003 | SESE |
| K023564 | OSSE-LIGN | Osseus, LLC | Mar 11, 2003 | SESE |
| K010943 | SYNTHES STERNAL FIXATION SYSTEM | Synthes (Usa) | Jun 27, 2001 | SESE |
| K003951 | PECTOFIX STERNAL REPAIR WIRE | Pectofix, Inc. | Mar 21, 2001 | SESE |
| K001254 | ORTHOMATRIX, INC. CERCLAGE SYSTEM | Orthomatrix, Inc. | Dec 13, 2000 | SESE |
| K002110 | SPL CRIMP SYSTEM | Pioneer Surgical Technology | Oct 6, 2000 | SESE |
| K001709 | TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODEL 501-066, 501-067 | Pioneer Surgical Technology | Aug 31, 2000 | SESE |
| K000694 | PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF) | Pectofix, Inc. | May 11, 2000 | SESE |
| K993903 | WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013 | Whiteside Biomechanics, Inc. | Feb 14, 2000 | SESE |
| K993286 | PIONEER SILICOAT STERNAL CABLE | Pioneer Surgical Technology | Nov 23, 1999 | SESE |
| K992891 | SYNTHES CERCLAGE POSITIONING PIN | Synthes (Usa) | Nov 2, 1999 | SESE |
| K992616 | SDB CERCLAGE SYSTEM | Pioneer Surgical Technology | Oct 27, 1999 | SESE |
| K984432 | DALL-MILES CABLE GRIP (A-GRIP) | Howmedica Osteonics Corp. | Feb 24, 1999 | SESE |
| K983976 | METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM | Metagen, LLC | Dec 30, 1998 | SESE |
| K982545 | BMP CABLE SYSTEM | Biomet, Inc. | Oct 19, 1998 | SESE |
| K980690 | CABLE SCREW WITH INTEGRAL CRIMP | Pioneer Surgical Technology | May 22, 1998 | SESE |
| K974020 | SPINAL CONCEPTS, INC., CFIX CABLE SYSTEM | Spinal Concepts, Inc. | Dec 19, 1997 | SESE |
| K974016 | CERCLAGE CABLE WITH HEX BUTTON | Pioneer Surgical Technology | Dec 19, 1997 | SESE |
| K973098 | COMPRESSION CERCLAGE GUNDOLF CCG-GF | Plus Orthopedics | Oct 27, 1997 | SESE |
| K972327 | METAGEN ACTIVELOCK CERCLAGE SYSTEM | Pacific Materials and Interfaces | Aug 11, 1997 | SESE |
| K971741 | DALL-MILES HOMOGENEOUS STAINLESS STEEL CABLE AND BEADED CABLE | Howmedica Corp. | Jul 16, 1997 | SESE |
| K970084 | LINK CERCLAGE WIRE SYSTEM | Turnkey Intergration USA, Inc. | Mar 13, 1997 | SESE |
| K962162 | DALL-MILES TROCHANTER CABLE SUPERGRIP | Howmedica Corp. | Aug 14, 1996 | SESE |
| K962132 | SILKON STAINLESS STEEL CABLE SYSTEM | Osteonics Corp. | Aug 8, 1996 | SESE |
| K961267 | PIONEER SYSTEM GTR(GREATER TROCHANTEER REATTACHMENT) DEVICE | Pioneer Surgical Technology | Jun 27, 1996 | SESE |
| K961569 | DALL-MILES STAINLESS STEEL BEADED CABLE | Howmedica Corp. | Jun 24, 1996 | SESE |
| K961283 | DALL-MILES HOMOGENOUS VITALLIUM CABLE | Howmedica Corp. | May 22, 1996 | SESE |
| K960651 | CERCLAGE WIRE CRIMP BLOCK | Acu-Med, Inc. | May 3, 1996 | SESE |
| K953777 | SYNTHES WIRE MOUNT | Synthes (Usa) | Mar 8, 1996 | SESE |
| K953818 | DALL-MILES SUTURE/BEADED CABLE | Howmedica Corp. | Oct 12, 1995 | SESE |
| K951844 | BIOMECHANIC LOW-PROFILE CABLE SYSTEM | Biomechanic, Inc. | Jul 13, 1995 | SN |
| K945294 | DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLE | Howmedica Corp. | Mar 7, 1995 | SN |
| K950027 | CABLE-EASE PLATE AND CABLE SYSTEM - TROCHANTERIC HOOK | Intermedics Orthopedics | Mar 6, 1995 | SN |
| K944529 | CABLE-EASE PLATE AND CABLE SYSTEM | Intermedics Orthopedics | Feb 17, 1995 | SN |
| K932024 | CCG CERCLAGE SYSTEM | Encore Orthopedics, Inc. | Feb 14, 1995 | SN |
| K942300 | SILKON TITANIUM CABLE SYSTEM | American Medical Electronics, Inc. | Jan 9, 1995 | SESK |
| K940729 | PIONEER LABORATORIES BONE PLATE WITH CERCLAGE CABLES | Pioneer Surgical Technology | Dec 21, 1994 | SESE |
| K934059 | DALL MILES SYSTEM GROOVED BUTTON | Howmedica Corp. | Aug 1, 1994 | SN |
| K932687 | AME(R) UNIVERSIAL CABLE SYSTEM | American Medical Electronics, Inc. | May 3, 1994 | SESE |
| K941213 | SONGER CABLE SYSTEM | Pioneer Surgical Technology | Apr 19, 1994 | SN |
| K935950 | FX-CABLELOK CABLE/PLATE SYSTEM | Buckman Co., Inc. | Mar 9, 1994 | SN |
| K935646 | FX-CABLELOK(TM) STOP(TROCHANTER HOOK) SYSTEM | Biodynamic Technologies, Inc. | Mar 9, 1994 | SN |
| K934557 | CONTROL CABLE SYSTEM | Depuy, Inc. | Feb 25, 1994 | SESE |
| K934058 | DALL MILES SYSTEM MINICLEAT | Howmedica Corp. | Feb 23, 1994 | SN |
| K934176 | SURGICAL ACCESSORIES LOOPED WIRE | Surgical Accessories, Inc. | Feb 22, 1994 | SESE |
| K931246 | CERCLAGE WIRE CRIMP SLEEVE | Acu Med, Inc. | Feb 22, 1994 | SESE |
| K935592 | SURGICAL ACCESSORIES COCR CABLE SYSTEM | Surgical Accessories, Inc. | Jan 26, 1994 | SESE |
| K935481 | SPONGER CABLE SYSTEM, MODIFICATION | Pioneer Surgical Technology | Jan 26, 1994 | SESE |
| K924141 | ORTHOPAEDIC POLYETHYLENE CABLE | Smith & Nephew Richards, Inc. | Nov 30, 1993 | SESE |
| K925447 | OTI ORTHOPEDIC WIRE SYSTEM | Osteo Technology, Inc. | Jun 29, 1993 | SESE |
| K930015 | STERNAL BAND | Stony Brook Surgical Innovations, Inc. | May 19, 1993 | SESE |
| K923869 | CODMAN SOF'WIRE TITANIUM CABLE SYSTEM | Codman & Shurtleff, Inc. | May 12, 1993 | SESE |
| K926116 | CODMAN SOFWIRE(TM) KIT | Codman & Shurtleff, Inc. | Mar 30, 1993 | SESE |
| K925812 | TITANIUM SONGER CABLE SYSTEM | Sofamor Danek Mfg., Inc. | Mar 24, 1993 | SESE |
| K922952 | SONGER CABLE SYSTEM | Pioneer Surgical Technology | Feb 23, 1993 | SESE |
| K922142 | FX-CABLELOK SYSTEM | Bio-Tech Co. | Nov 20, 1992 | SESE |
| K921480 | OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM | Acu-Med, Inc. | Jun 26, 1992 | SESE |
| K920201 | TITANIUM ALLOY SONGER CABLE SYSTEM | Sofamor Danek Mfg., Inc. | Apr 8, 1992 | SN |
| K915259 | FX-CABLELOK SYSTEM, MODIFICATION | Biodynamic Technologies, Inc. | Feb 7, 1992 | SESE |
| K915581 | CODMAN SOF'WIRE (TM) KIT | Codman & Shurtleff, Inc. | Jan 16, 1992 | SESE |
| K914374 | OSTEO CERCLAGE WIRE | Osteo AG | Dec 30, 1991 | SESE |
| K914693 | DEPUY (NITINO) GUIDE WIRE | Depuy, Inc. | Dec 9, 1991 | SESE |
| K913735 | SONGER(TM) CABLE SYSTEM | Danek Medical, Inc. | Nov 18, 1991 | SESE |
| K912207 | FX-CABLELOK SYSTEM | Biodynamic Technologies, Inc. | Jul 9, 1991 | SESE |
| K910128 | LEVTECH TITANIUM BONE WIRE | Levtech, Inc. | Jun 18, 1991 | SESE |
| K903676 | STERNOTOMY CABLE, SONGER CABLE SYSTEM | Danek Medical, Inc. | Sep 10, 1990 | SESE |
| K892411 | MENNEN BONE FIXATION DEVICE | Dentsply Intl. | Jan 5, 1990 | SESE |
| K882967 | BONE FIXATION WIRE | Baxter Healthcare Corp | Sep 30, 1988 | SESE |
| K882890 | WROBLEWSKI SPRING COMPRESSION WIRE SYSTEM | Thackray USA | Aug 8, 1988 | SESE |
| K880309 | TYPE 316L STAINLESS STEEL WIRE | Winn Hirsch & Assoc. | Feb 29, 1988 | SESE |
| K875156 | STAINLESS STEEL ORTHOPAEDIC CABLE SYSTEM | Richards Medical Co., Inc. | Jan 20, 1988 | SESE |
| K874919 | ORTHOMET WIRE FOR SUTURE, CERCLAGE | Orthomet, Inc. | Jan 7, 1988 | SESE |
| K850631 | KIRSCHNER ORTHOPEDIC WIRE, EYELET CERCLAGE WIRES | Kirschner Medical Corp. | May 1, 1985 | SESE |
| K842977 | ORTHOPAEDIC CABLE SYSTEM | Richards Medical Co., Inc. | Oct 26, 1984 | SESE |
Top Applicants
- Pioneer Surgical Technology — 11 clearances
- Synthes (Usa) — 8 clearances
- Howmedica Corp. — 8 clearances
- A & E Medical Corporation — 4 clearances
- Smith & Nephew, Inc. — 3 clearances
