Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JDQ — Predicate Candidate Screening
130 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
270 days90th percentile
130clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261271 | Cable-Ready® Cable Grip System | Pioneer Surgical Technology, Inc. | 2026-07-16 | 90 | 0 |
| K243905 | Stitch Cerclage – Suture Tapes | GM Dos Reis Industria e Comercio Ltda. | 2025-08-14 | 238 | 0 |
| K243344 | Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Ra | Arthrex, Inc. | 2025-02-20 | 118 | 0 |
| K232733 | Mbrace Cable | Medacta International S.A. | 2024-05-03 | 239 | 0 |
| K233949 | ACCORD Cable System | Smith & Nephew, Inc. | 2024-03-13 | 90 | 0 |
| K232986 | VariTrax Sternal CircumFixation System | Circumfix Solutions, Inc. | 2024-01-30 | 130 | 0 |
| K230976 | Arthrex Radiopaque FiberTape Cerclage sutures | Arthrex, Inc. | 2023-08-24 | 141 | 0 |
| K231333 | STRETTO™ Cable System | Globus Medical, Inc. | 2023-08-04 | 88 | 0 |
| K220765 | HS Fiber Cerclage | Riverpoint Medical, LLC | 2023-07-26 | 497 | 0 |
| K221795 | STERN FIX Sternal Stabilization System | Neos Surgery S.L | 2022-10-19 | 120 | 0 |
| K211613 | Stern Fix Sternal Stabilization System | Neos Surgery S.L | 2022-01-19 | 238 | 0 |
| K201497 | EVOS Cabling System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2020-10-28 | 145 | 0 |
| K202016 | Dall-Miles® Cable System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2020-10-16 | 87 | 0 |
| K193479 | Sternal Cable System | A & E Medical Corporation | 2020-03-23 | 98 | 0 |
| K193468 | Tritium Sternal Cable Plate System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2020-03-12 | 87 | 0 |
| K181607 | Thorecon Rigid Fixation System | A & E Medical Corporation | 2018-10-12 | 115 | 0 |
| K173910 | Impress SFS System | Cable Fix Medical, LLC | 2018-09-14 | 266 | 0 |
| K181749 | SuperCable® Iso-Elastic™ Cerclage System | Kinamed, Incorporated | 2018-08-01 | 30 | 0 |
| K172975 | DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – M | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | 2018-06-21 | 267 | 0 |
| K180582 | Sternal Cable System | A & E Medical Corporation | 2018-05-31 | 87 | 0 |
| K173579 | Thorecon™ Fixation System | A & E Medical Corporation | 2018-02-12 | 84 | 0 |
| K170206 | Arthrex FiberTape Cerclage | Arthrex, Inc. | 2017-11-15 | 295 | 0 |
| K161876 | Tritium® Sternal Cable Plate System | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | 2016-09-09 | 63 | 0 |
| K151983 | KLS Martin LSS Plating System | KLS Martin L.P. | 2016-04-06 | 264 | 0 |
| K151848 | Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cabl | Zimmer, Inc. | 2016-01-15 | 192 | 0 |
| K153242 | Frontier Medical Devices In-Line Orthopedic Cable Cerclage S | Frontier Medical Devices, Inc. | 2016-01-13 | 65 | 0 |
| K151888 | Frontier Medical Devices In-line Orthopedic Cable Cerclage S | Frontier Medical Devices, Inc. | 2015-10-30 | 112 | 0 |
| K143716 | DSM Biomedical DPR Cable | Dsm Biomedical | 2015-10-29 | 304 | 0 |
| K151346 | Frontier Medical Devices Posterior Cable Screw System | Frontier Medical Devices, Inc. | 2015-08-20 | 92 | 0 |
| K150889 | Suture Wires and Wire Loops | Zimmer, Inc. | 2015-07-01 | 90 | 0 |
| K150581 | Tritium Sternal Cable Plate System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2015-06-04 | 87 | 0 |
| K133354 | PERI-PROSTHETIC CABLE SYSTEM | Biomet, Inc. | 2014-01-27 | 88 | 0 |
| K133785 | TRITIUM STERNAL CABLE PLATE SYSTEM | Pioneer Surgical Technology, Inc. | 2014-01-27 | 46 | 1 |
| K130431 | COMPRESSYN BAND | Dallen Medical, Inc. | 2013-07-25 | 154 | 0 |
| K121541 | JAZZ SYSTEM | Implanet, S.A. | 2012-09-13 | 112 | 0 |
| K120177 | SPINAL ELEMENTS CERCLAGE SYSTEM | Spinal Elements, Inc. | 2012-07-03 | 165 | 0 |
| K112736 | PASS LP SPINAL | Medicrea International | 2012-02-01 | 134 | 0 |
| K110789 | SYNTHES STERNAL ZIPFIX SYSTEM | Synthes (Usa) | 2011-07-28 | 128 | 3 |
| K110541 | FIGURE 8 STERNOTOMY CLOSURE DEVICE | Figure 8 Surgical, Incorporated | 2011-07-06 | 131 | 0 |
| K103797 | K2M COCR WIRE | K2m, Inc. | 2011-05-20 | 144 | 0 |
| K110039 | BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM | Biomet Sports Medicine | 2011-05-03 | 117 | 0 |
| K101484 | COMPRESSYN BAND | Dallen Medical | 2011-04-01 | 308 | 0 |
| K102834 | ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER) | Kinamed, Incorporated | 2011-01-12 | 105 | 0 |
| K090686 | SIC BREVETTI S.R.L. DEVICE FOR STERNAL SYNTHESIS | Sic Brevetti S.R.L. | 2009-12-08 | 267 | 0 |
| K091190 | UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-3006 | Zimmer Spine, Inc. | 2009-07-30 | 98 | 0 |
| K081622 | UNIVERSAL CLAMP STAINLESS STEEL SYSTEM | Abbott Spine, Inc. | 2008-08-29 | 80 | 0 |
| K081205 | SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS | Synthes (Usa) | 2008-07-01 | 63 | 0 |
| K071271 | BIOMET CABLE SYSTEM | Biomet Manufacturing, Inc. | 2007-10-23 | 169 | 0 |
| K063017 | AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM | Aesculap, Inc. | 2006-12-27 | 86 | 0 |
| K060009 | ABBOTT SPINE UNIVERSAL CLAMP SYSTEM | Abbott Spine, Inc. | 2006-03-06 | 62 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda