Atlas FDA

JDQ

130 FDA 510(k) clearances · Product code

90 daysmedian time to decision
270 days90th percentile
130clearances measured

FDA profile

Official device name
Cerclage, Fixation
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3010
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 141 · 2022: 134 · 2023: 98 · 2024: 115 · 2025: 88 · 2026: 70
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Cable-Ready® Cable Grip System (K261271)Pioneer Surgical Technology, Inc.2026-07-16
Stitch Cerclage – Suture Tapes (K243905)GM Dos Reis Industria e Comercio Ltda.2025-08-14
Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures (K243344)Arthrex, Inc.2025-02-20
Mbrace Cable (K232733)Medacta International S.A.2024-05-03
ACCORD Cable System (K233949)Smith & Nephew, Inc.2024-03-13
VariTrax Sternal CircumFixation System (K232986)Circumfix Solutions, Inc.2024-01-30
Arthrex Radiopaque FiberTape Cerclage sutures (K230976)Arthrex, Inc.2023-08-24
STRETTO™ Cable System (K231333)Globus Medical, Inc.2023-08-04
HS Fiber Cerclage (K220765)Riverpoint Medical, LLC2023-07-26
STERN FIX Sternal Stabilization System (K221795)Neos Surgery S.L2022-10-19
Stern Fix Sternal Stabilization System (K211613)Neos Surgery S.L2022-01-19
EVOS Cabling System (K201497)Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2020-10-28
Dall-Miles® Cable System (K202016)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2020-10-16
Sternal Cable System (K193479)A & E Medical Corporation2020-03-23
Tritium Sternal Cable Plate System (K193468)Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2020-03-12
Thorecon Rigid Fixation System (K181607)A & E Medical Corporation2018-10-12
Impress SFS System (K173910)Cable Fix Medical, LLC2018-09-14
SuperCable® Iso-Elastic™ Cerclage System (K181749)Kinamed, Incorporated2018-08-01
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 (K172975)Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.2018-06-21
Sternal Cable System (K180582)A & E Medical Corporation2018-05-31
Thorecon™ Fixation System (K173579)A & E Medical Corporation2018-02-12
Arthrex FiberTape Cerclage (K170206)Arthrex, Inc.2017-11-15
Tritium® Sternal Cable Plate System (K161876)Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.2016-09-09
KLS Martin LSS Plating System (K151983)KLS Martin L.P.2016-04-06
Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System (K151848)Zimmer, Inc.2016-01-15
Frontier Medical Devices In-Line Orthopedic Cable Cerclage System (K153242)Frontier Medical Devices, Inc.2016-01-13
Frontier Medical Devices In-line Orthopedic Cable Cerclage System (K151888)Frontier Medical Devices, Inc.2015-10-30
DSM Biomedical DPR Cable (K143716)Dsm Biomedical2015-10-29
Frontier Medical Devices Posterior Cable Screw System (K151346)Frontier Medical Devices, Inc.2015-08-20
Suture Wires and Wire Loops (K150889)Zimmer, Inc.2015-07-01
Tritium Sternal Cable Plate System (K150581)Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2015-06-04
PERI-PROSTHETIC CABLE SYSTEM (K133354)Biomet, Inc.2014-01-27
TRITIUM STERNAL CABLE PLATE SYSTEM (K133785)Pioneer Surgical Technology, Inc.2014-01-27
COMPRESSYN BAND (K130431)Dallen Medical, Inc.2013-07-25
JAZZ SYSTEM (K121541)Implanet, S.A.2012-09-13
SPINAL ELEMENTS CERCLAGE SYSTEM (K120177)Spinal Elements, Inc.2012-07-03
PASS LP SPINAL (K112736)Medicrea International2012-02-01
SYNTHES STERNAL ZIPFIX SYSTEM (K110789)Synthes (Usa)2011-07-28
FIGURE 8 STERNOTOMY CLOSURE DEVICE (K110541)Figure 8 Surgical, Incorporated2011-07-06
K2M COCR WIRE (K103797)K2m, Inc.2011-05-20
BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM (K110039)Biomet Sports Medicine2011-05-03
COMPRESSYN BAND (K101484)Dallen Medical2011-04-01
ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER) (K102834)Kinamed, Incorporated2011-01-12
SIC BREVETTI S.R.L. DEVICE FOR STERNAL SYNTHESIS (K090686)Sic Brevetti S.R.L.2009-12-08
UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063 (K091190)Zimmer Spine, Inc.2009-07-30
UNIVERSAL CLAMP STAINLESS STEEL SYSTEM (K081622)Abbott Spine, Inc.2008-08-29
SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS (K081205)Synthes (Usa)2008-07-01
BIOMET CABLE SYSTEM (K071271)Biomet Manufacturing, Inc.2007-10-23
AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM (K063017)Aesculap, Inc.2006-12-27
ABBOTT SPINE UNIVERSAL CLAMP SYSTEM (K060009)Abbott Spine, Inc.2006-03-06
SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM (K050041)Synthes (Usa)2005-02-25
CABLING SYSTEM TROCHANTER HOOK (K043252)Smith & Nephew, Inc.2005-01-14
SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM (K033816)Synthes (Usa)2004-03-02
OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS (K040199)Osseus, LLC2004-02-20
ISO-ELASTIC CERCLAGE SYSTEM (K030256)Kinamed, Inc.2003-10-21
SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM (K031508)Synthes (Usa)2003-05-30
SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM (K031162)Smith & Nephew, Inc.2003-05-01
OSSE-LIGN (K023564)Osseus, LLC2003-03-11
SYNTHES STERNAL FIXATION SYSTEM (K010943)Synthes (Usa)2001-06-27
PECTOFIX STERNAL REPAIR WIRE (K003951)Pectofix, Inc.2001-03-21
ORTHOMATRIX, INC. CERCLAGE SYSTEM (K001254)Orthomatrix, Inc.2000-12-13
SPL CRIMP SYSTEM (K002110)Pioneer Surgical Technology2000-10-06
TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODEL 501-066, 501-067 (K001709)Pioneer Surgical Technology2000-08-31
PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF) (K000694)Pectofix, Inc.2000-05-11
WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013 (K993903)Whiteside Biomechanics, Inc.2000-02-14
PIONEER SILICOAT STERNAL CABLE (K993286)Pioneer Surgical Technology1999-11-23
SYNTHES CERCLAGE POSITIONING PIN (K992891)Synthes (Usa)1999-11-02
SDB CERCLAGE SYSTEM (K992616)Pioneer Surgical Technology1999-10-27
DALL-MILES CABLE GRIP (A-GRIP) (K984432)Howmedica Osteonics Corp.1999-02-24
METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM (K983976)Metagen, LLC1998-12-30
BMP CABLE SYSTEM (K982545)Biomet, Inc.1998-10-19
CABLE SCREW WITH INTEGRAL CRIMP (K980690)Pioneer Surgical Technology1998-05-22
CERCLAGE CABLE WITH HEX BUTTON (K974016)Pioneer Surgical Technology1997-12-19
SPINAL CONCEPTS, INC., CFIX CABLE SYSTEM (K974020)Spinal Concepts, Inc.1997-12-19
COMPRESSION CERCLAGE GUNDOLF CCG-GF (K973098)Plus Orthopedics1997-10-27
METAGEN ACTIVELOCK CERCLAGE SYSTEM (K972327)Pacific Materials and Interfaces1997-08-11
DALL-MILES HOMOGENEOUS STAINLESS STEEL CABLE AND BEADED CABLE (K971741)Howmedica Corp.1997-07-16
LINK CERCLAGE WIRE SYSTEM (K970084)Turnkey Intergration USA, Inc.1997-03-13
DALL-MILES TROCHANTER CABLE SUPERGRIP (K962162)Howmedica Corp.1996-08-14
SILKON STAINLESS STEEL CABLE SYSTEM (K962132)Osteonics Corp.1996-08-08
PIONEER SYSTEM GTR(GREATER TROCHANTEER REATTACHMENT) DEVICE (K961267)Pioneer Surgical Technology1996-06-27
DALL-MILES STAINLESS STEEL BEADED CABLE (K961569)Howmedica Corp.1996-06-24
DALL-MILES HOMOGENOUS VITALLIUM CABLE (K961283)Howmedica Corp.1996-05-22
CERCLAGE WIRE CRIMP BLOCK (K960651)Acu-Med, Inc.1996-05-03
SYNTHES WIRE MOUNT (K953777)Synthes (Usa)1996-03-08
DALL-MILES SUTURE/BEADED CABLE (K953818)Howmedica Corp.1995-10-12
BIOMECHANIC LOW-PROFILE CABLE SYSTEM (K951844)Biomechanic, Inc.1995-07-13
DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLE (K945294)Howmedica Corp.1995-03-07
CABLE-EASE PLATE AND CABLE SYSTEM - TROCHANTERIC HOOK (K950027)Intermedics Orthopedics1995-03-06
CABLE-EASE PLATE AND CABLE SYSTEM (K944529)Intermedics Orthopedics1995-02-17
CCG CERCLAGE SYSTEM (K932024)Encore Orthopedics, Inc.1995-02-14
SILKON TITANIUM CABLE SYSTEM (K942300)American Medical Electronics, Inc.1995-01-09
PIONEER LABORATORIES BONE PLATE WITH CERCLAGE CABLES (K940729)Pioneer Surgical Technology1994-12-21
DALL MILES SYSTEM GROOVED BUTTON (K934059)Howmedica Corp.1994-08-01
AME(R) UNIVERSIAL CABLE SYSTEM (K932687)American Medical Electronics, Inc.1994-05-03
SONGER CABLE SYSTEM (K941213)Pioneer Surgical Technology1994-04-19
FX-CABLELOK CABLE/PLATE SYSTEM (K935950)Buckman Co., Inc.1994-03-09
FX-CABLELOK(TM) STOP(TROCHANTER HOOK) SYSTEM (K935646)Biodynamic Technologies, Inc.1994-03-09
CONTROL CABLE SYSTEM (K934557)Depuy, Inc.1994-02-25
DALL MILES SYSTEM MINICLEAT (K934058)Howmedica Corp.1994-02-23
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Every clearance here is in the API, with alerts when new ones post.