Panels › Orthopedic › Product code JDQ · Class 2
Cerclage, Fixation
Regulation 888.3010
1510(k)s in 12 months (130 all time)
0recalls in 12 months (15 all time)
11recalls that name a 510(k)
Top companies in JDQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Pioneer Surgical Technology | 13 | 1 |
| Howmedica Corp. | 8 | 0 |
| Synthes (Usa) | 8 | 0 |
| Alto Development Corp | 0 | 5 |
| Smith & Nephew, Inc. | 3 | 2 |
| A & E Medical Corporation | 4 | 0 |
| Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 4 | 0 |
| Acu Med, Inc. | 3 | 0 |
| Arthrex, Inc. | 3 | 0 |
| Biodynamic Technologies, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 16, 2026 | K261271 | Cable-Ready® Cable Grip System Pioneer Surgical Technology, Inc. | JDQ |
| Aug 14, 2025 | K243905 | Stitch Cerclage Suture Tapes GM Dos Reis Industria e Comercio Ltda., BR | JDQ |
| Feb 20, 2025 | K243344 | Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures Arthrex, Inc. | JDQ |
| May 3, 2024 | K232733 | Mbrace Cable Medacta International S.A., CH | JDQ |
| Mar 13, 2024 | K233949 | ACCORD Cable System Smith & Nephew, Inc. | JDQ |
| Jan 30, 2024 | K232986 | VariTrax Sternal CircumFixation System Circumfix Solutions, Inc. | JDQ |
| Aug 24, 2023 | K230976 | Arthrex Radiopaque FiberTape Cerclage sutures Arthrex, Inc. | JDQ |
| Aug 4, 2023 | K231333 | STRETTO Cable System Globus Medical, Inc. | JDQ |
| Jul 26, 2023 | K220765 | HS Fiber Cerclage Riverpoint Medical, LLC | JDQ |
| Oct 19, 2022 | K221795 | STERN FIX Sternal Stabilization System Neos Surgery S.L, ES | JDQ |
| Jan 19, 2022 | K211613 | Stern Fix Sternal Stabilization System Neos Surgery S.L, ES | JDQ |
| Oct 28, 2020 | K201497 | EVOS Cabling System Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | JDQ |
| Oct 16, 2020 | K202016 | Dall-Miles® Cable System Howmedica Osteonics Corp., Dba Stryker Orthopaedics | JDQ |
| Mar 23, 2020 | K193479 | Sternal Cable System A & E Medical Corporation | JDQ |
| Mar 12, 2020 | K193468 | Tritium Sternal Cable Plate System Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | JDQ |
| Oct 12, 2018 | K181607 | Thorecon Rigid Fixation System A & E Medical Corporation | JDQ |
| Sep 14, 2018 | K173910 | Impress SFS System Cable Fix Medical, LLC | JDQ |
| Aug 1, 2018 | K181749 | SuperCable® Iso-Elastic Cerclage System Kinamed, Incorporated | JDQ |
| Jun 21, 2018 | K172975 | DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins MR Conditional, DePuy Synthes Variable Angle Positioning Pins Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | JDQ |
| May 31, 2018 | K180582 | Sternal Cable System A & E Medical Corporation | JDQ |
| Feb 12, 2018 | K173579 | Thorecon Fixation System A & E Medical Corporation | JDQ |
| Nov 15, 2017 | K170206 | Arthrex FiberTape Cerclage Arthrex, Inc. | JDQ |
| Sep 9, 2016 | K161876 | Tritium® Sternal Cable Plate System Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | JDQ |
| Apr 6, 2016 | K151983 | KLS Martin LSS Plating System KLS Martin L.P. | JDQ |
| Jan 15, 2016 | K151848 | Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System Zimmer, Inc. | JDQ |
| Jan 13, 2016 | K153242 | Frontier Medical Devices In-Line Orthopedic Cable Cerclage System Frontier Medical Devices, Inc. | JDQ |
| Oct 30, 2015 | K151888 | Frontier Medical Devices In-line Orthopedic Cable Cerclage System Frontier Medical Devices, Inc. | JDQ |
| Oct 29, 2015 | K143716 | DSM Biomedical DPR Cable Dsm Biomedical | JDQ |
| Aug 20, 2015 | K151346 | Frontier Medical Devices Posterior Cable Screw System Frontier Medical Devices, Inc. | JDQ |
| Jul 1, 2015 | K150889 | Suture Wires and Wire Loops Zimmer, Inc. | JDQ |
| Jun 4, 2015 | K150581 | Tritium Sternal Cable Plate System Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | JDQ |
| Jan 27, 2014 | K133785 | TRITIUM STERNAL CABLE PLATE SYSTEM Pioneer Surgical Technology, Inc. | JDQ |
| Jan 27, 2014 | K133354 | PERI-PROSTHETIC CABLE SYSTEM Biomet, Inc. | JDQ |
| Jul 25, 2013 | K130431 | COMPRESSYN BAND Dallen Medical, Inc. | JDQ |
| Sep 13, 2012 | K121541 | JAZZ SYSTEM Implanet, S.A. | JDQ |
| Jul 3, 2012 | K120177 | SPINAL ELEMENTS CERCLAGE SYSTEM Spinal Elements, Inc. | JDQ |
| Feb 1, 2012 | K112736 | PASS LP SPINAL Medicrea International | JDQ |
| Jul 28, 2011 | K110789 | SYNTHES STERNAL ZIPFIX SYSTEM Synthes (Usa) | JDQ |
| Jul 6, 2011 | K110541 | FIGURE 8 STERNOTOMY CLOSURE DEVICE Figure 8 Surgical, Incorporated | JDQ |
| May 20, 2011 | K103797 | K2M COCR WIRE K2m, Inc. | JDQ |
| May 3, 2011 | K110039 | BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM Biomet Sports Medicine | JDQ |
| Apr 1, 2011 | K101484 | COMPRESSYN BAND Dallen Medical | JDQ |
| Jan 12, 2011 | K102834 | ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER) Kinamed, Incorporated | JDQ |
| Dec 8, 2009 | K090686 | SIC BREVETTI S.R.L. DEVICE FOR STERNAL SYNTHESIS Sic Brevetti S.R.L. | JDQ |
| Jul 30, 2009 | K091190 | UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063 Zimmer Spine, Inc. | JDQ |
| Aug 29, 2008 | K081622 | UNIVERSAL CLAMP STAINLESS STEEL SYSTEM Abbott Spine, Inc. | JDQ |
| Jul 1, 2008 | K081205 | SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS Synthes (Usa) | JDQ |
| Oct 23, 2007 | K071271 | BIOMET CABLE SYSTEM Biomet Manufacturing, Inc. | JDQ |
| Dec 27, 2006 | K063017 | AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM Aesculap, Inc. | JDQ |
| Mar 6, 2006 | K060009 | ABBOTT SPINE UNIVERSAL CLAMP SYSTEM Abbott Spine, Inc. | JDQ |
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