Atlas FDA

JDK

54 FDA 510(k) clearances · Product code

85 daysmedian time to decision
197 days90th percentile
54clearances measured

FDA profile

Official device name
Prosthesis, Hip, Cement Restrictor
Device class
Class II (moderate risk)
Regulation
21 CFR 878.3300
Medical specialty
General, Plastic Surgery
Flags
Implant
Adverse events (MAUDE)
2004: 2 · 2005: 9 · 2006: 2 · 2007: 3 · 2008: 5 · 2019: 13
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Mectaplug PE II (K210062)Medacta International S.A.2021-04-08
KMI CEMENT RESTRICTOR IMPLANT (K061465)Kinetikos Medical, Inc.2006-10-05
MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR (K061698)Life Spine2006-07-12
LIFE SPINE CEMENT RESTRICTOR (K060247)Life Spine2006-05-11
SPINAL USA CEMENT RESTRICTOR SYSTEM (K060132)Spinal USA2006-03-16
INTERBODY INNOVATIONS CEMENT RESTRICTOR (K051371)Interbody Innovations, Llp2005-12-06
SKELITE RESORBABLE CEMENT RESTRICTOR (K051836)Millenium Biologix, Inc.2005-11-21
NOVASPINE CEMENT RESTRICTOR NSCR (K051607)Novaspine, LLC2005-10-07
SCIENT'X CEMENT RESTRICTOR (K052367)Scient'X2005-10-05
POLYGRAFT BGS; BONE GRAFT SUBSTITUTE (K041382)Osteobiologics, Inc.2005-06-17
MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004 (K050699)Amedica Corp.2005-04-15
PEEK CEMENT RESTRICTOR X-BOX (K041583)Innovasis, Inc.2004-07-22
OPTIMESH 500E CEMENT RESTRICTOR (K033953)Spineology, Inc.2004-07-06
QUANTUM CEMENT RESTRICTOR (K040276)Quantum Orthopedics2004-04-30
FIDJI LARGE CEMENT RESTRICTOR (K030871)Spine Next SA2003-12-22
FIDJI SMALL CEMENT RESTRICTOR (K030767)Spine Next SA2003-12-22
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ (K033384)Implex Corp.2003-11-19
NUVASIVE CEMENT RESTRICTOR (K032180)Nuvasive, Inc.2003-10-07
TRAXIS CEMENT RESTRICTOR (K031318)Spinal Concepts, Inc.2003-08-22
INTERPORE CROSS CEMENT RESTRICTOR (K032095)Interpore Cross Intl.2003-08-08
MODIFICATION TO FORTITUDE CEMENT RESTRICTOR (K031837)Spinal Concepts, Inc.2003-07-24
OTI BONE CEMENT PLUG (K030608)Osteoimplant Technology, Inc.2003-06-12
INTERPORE CROSS CEMENT RESTRICTOR (K023908)Interpore Cross Intl.2003-05-16
CADENCE PEEK CEMEENT RESTRICTOR (K023647)Spinal Concepts, Inc.2002-11-27
CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR (K022615)Centerpulse Spine-Tech, Inc.2002-10-29
NBD CEMENT RESTRICTOR DEVICE (K021788)New Business Development, LLC2002-10-04
CEMENT RESTRICTOR, SMALL AND LARGE (K021765)Exactech, Inc.2002-08-16
FORTITUDE CEMENT RESTRICTOR (K021719)Spinal Concepts, Inc.2002-08-15
CADENCE CEMENT RESTRICTOR (K022218)Spinal Concepts, Inc.2002-08-12
RABEA CEMENT RESTRICTOR (K020836)Signus Medical, LLC2002-06-11
RPX TITANIUM CEMNT RESTRICTOR (K020344)Sulzer Spine-Tech2002-05-02
CEMENT RESTRICTOR (K013663)Medtronic Sofamor Danek, Inc.2001-12-05
THEKEN LARGE CEMENT RESTRICTOR (K012462)Theken Surgical,Llc2001-10-29
THEKEN SMALL CEMENT RESTRICTOR (K012278)Theken Surgical,Llc2001-10-17
TITANIUM CEMENT RESTRICTOR MATERIAL PEEK (K010528)Medtronic Sofamor Danek USA, Inc.2001-10-10
BLOCK CEMENT RESTRICTOR (CR) - TITANIUM (K013014)Medtronic Sofamor Danek, Inc.2001-10-04
THREADED CEMENT RESTRICTOR (CR) TITANIUM (K011443)Medtronic Sofamor Danek USA, Inc.2001-08-03
MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR (K012255)Medtronic Sofamor Danek, Inc.2001-08-01
METRONIC SOFAMOR DANEK CEMENT RESTRICTOR (K011998)Medtronic Sofamor Danek, Inc.2001-07-26
TITANIUM CEMENT RESTRICTOR (TCR) (K003718)Medtronic Sofamor Danek, Inc.2001-02-14
RABEA DEVICE, MODEL PXXXXXX (K990345)Signus Medizintechnik GmbH1999-07-30
OSTEONICS SCREW HOLE PLUGS (K965056)Osteonics Corp.1997-02-28
BONE CEMENT RESTRICTOR (K926216)Biodynamic Technologies, Inc.1994-03-22
OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR (K923616)Osteonics Corp.1992-10-30
LIMA CEMENT RESTRICTOR (K911338)Turnkey Intergration USA, Inc.1991-06-28
OSTEONICS(R) MID-SHAFT CEMENT SPACER (K910461)Osteonics Corp.1991-04-08
S-ROM(TM) FEMORAL STEM CENTRALIZER/CEMENT SPACER (K904746)Joint Medical Products Corp.1990-11-20
OSTEONICS CEMENT RESTRICTOR (K900462)Osteonics Corp.1990-03-06
PROXIMAL CEMENT SPACER (K895378)Osteonics Reconstructive Products Div.1989-11-22
PT DISTAL TIP CEMENT SPACER (K894708)Osteonics Corp.1989-10-10
OMNIFIT DISTAL STEM CEMENT SPACERS (K872528)Osteonics Corp.1987-12-29
CEMENT RESTRICTOR (K840413)American Ortomed Corp.1984-03-05
DOSIMETRY RELEASE OF RADIATION STERILIZ (K831512)Biomet, Inc.1983-09-29
BARD INTRAMEDULLARY PLUG (K831128)C.R. Bard, Inc.1983-07-12

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Every clearance here is in the API, with alerts when new ones post.