Atlas FDA

ETB

74 FDA 510(k) clearances · Product code

41 daysmedian time to decision
158 days90th percentile
74clearances measured

FDA profile

Official device name
Prosthesis, Partial Ossicular Replacement
Device class
Class II (moderate risk)
Regulation
21 CFR 874.3450
Medical specialty
Ear, Nose, Throat
Flags
Implant
Adverse events (MAUDE)
2002: 6 · 2004: 2 · 2005: 5 · 2006: 3 · 2008: 5 · 2010: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850) (K260718)MED-EL Elektromedizinische Geräte GmbH2026-04-03
mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735); (K260720)MED-EL Elektromedizinische Geräte GmbH2026-04-03
mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit (K241261)MED-EL Elektromedizinische Geräte GmbH2025-01-17
mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis (K241142)MED-EL Elektromedizinische Geräte GmbH2025-01-17
NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS (K130512)Heinz Kurz GmbH Medizintechnik2013-12-02
NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS (K112616)Heinz Kurz GmbH Medizintechnik2013-02-08
K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES (K080070)Grace Medical, Inc.2008-04-17
NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE (K063374)Grace Medical, Inc.2006-12-06
GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES (K061853)Grace Medical, Inc.2006-08-18
PARTIAL OSSICULAR REPLACEMENT PROSTHESES (K060518)Grace Medical, Inc.2006-06-28
SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS (K033554)Gyrus Ent LLC2003-11-24
CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861 (K021479)Heinz Kurz GmbH Medizintechnik2002-05-21
CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257 (K013573)Heinz Kurz GmbH Medizintechnik2001-11-09
KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652 (K010442)Heinz Kurz2001-03-08
SMITH & NEPHEW PISTONS (K003214)Gyrus Ent LLC2000-10-31
SMITH & NEPHEW PORPS & TORPS (K002737)Gyrus Ent LLC2000-10-12
TITANIUM MIDDLE EAR PROSTHESES (K002897)Xomed, Inc.2000-10-11
SMITH & NEPHEW OFF-CENTERED PORP (K002464)Gyrus Ent LLC2000-08-29
KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170 (K002221)Heinz Kurz GmbH Medizintechnik2000-08-09
AUDIO TECHNOLOGIES S:R.1 (K001142)Audio Technologies S.R.L.2000-06-23
WEHRS INCUS-STAPES (K000858)Gyrus Ent LLC2000-04-03
CAP PORP, CAP TORP (K000256)Gyrus Ent LLC2000-02-11
MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (K993234)Micromedics, Inc.1999-11-10
SOCKET STAPES PISTON W/O LOOP, SCHOBEL, SCHOBEL-CAUSSE (K992839)Heinz Kurz GmbH Medizintechnik1999-09-16
STAPES PROSTHESES (K991394)Grace Medical, Inc.1999-05-18
TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 & BELL 1002 010 (K990923)Heinz Kurz1999-03-31
EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS (K981045)Exmoor Plastics , Ltd.1998-05-20
MILLS INCUS HA SLEEVE (K974365)Exmoor Plastics , Ltd.1998-01-22
K-PISTON WITH BAND HOOK /ANGULAR PISTON (K973356)Heinz Kurz1997-11-21
PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT (K972815)Grace Medical, Inc.1997-10-08
PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP) (K972734)Mednet Locator, Inc.1997-09-05
CAUSSE PISTON (K972737)Mednet Locator, Inc.1997-09-05
BELL PROSTHESIS (PARTIAL) (K972492)Heinz Kurz1997-08-04
ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS (K964909)Xomed, Inc.1997-03-10
RICHARDS TOTAL/PARTIAL PROSTHESIS (K962564)Gyrus Ent LLC1997-01-22
PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (K964798)Anthony D. Prescott1997-01-02
PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS (K963752)Grace Medical, Inc.1996-10-10
POLY/PLATINUM WIRE PISTON (K945105)Micromed Development Corp.1996-05-14
MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (K955613)Misten Medical Corp.1995-12-22
TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT (K954517)Trebay Medical Corp.1995-10-27
RICHARDS PORP (K952481)Smith & Nephew Richards, Inc.1995-06-16
HAPEX PORP (K950886)Smith & Nephew Richards, Inc.1995-03-15
HAPEX MALLEABLE PORP (K950885)Smith & Nephew Richards, Inc.1995-03-15
HAPES MALLEABLE INCUS STAPES (K950984)Smith & Nephew Richards, Inc.1995-03-15
HAPEX INCUS (K950887)Smith & Nephew Richards, Inc.1995-03-15
MICROMED PARTIAL REGULAR AND PARTIAL OFFSET (K945104)Micromed Development Corp.1994-11-22
POLY-WIRE PISTON (K945107)Micromed Development Corp.1994-11-22
POLY PISTON (K945108)Micromed Development Corp.1994-11-22
INCUDOSTAPEDIAL JOINT (K925443)Smith & Nephew Richards, Inc.1993-03-08
TEF/PLATINUM PISTON (K915120)River Medical, Inc.1991-12-27
TEF/WIRE PISTON (K915121)River Medical, Inc.1991-12-23
H/A PARTIAL - REGULAR & H/A PARTIAL - OFFSET (K913287)River Medical, Inc.1991-12-18
PTFE PISTON (K913285)River Medical, Inc.1991-12-18
WEHRS INCUS AND INCUS-STAPES PROSTHESES (K910685)Smith & Nephew Richards, Inc.1991-12-04
CERAVITAL MIDDLE EAR IMPLANT (K913619)Friedrichsfeld Medizintechnik AG1991-10-15
MICROTEK PISTON & WIRE PROSTHESES (K895814)Microbio-Medics, Inc.1989-12-26
APACERAM OSSICULAR PROSTHESIS (K893134)Asahi Optical Co. C/O Rosati Associates, P.C.1989-08-03
BUCKET PROSTHESIS PORP (K883727)Treace Medical, Inc.1989-01-13
XOMED PLATINUM WIRE TEFLON PISTION (K872112)Xomed, Inc.1987-07-02
PROSTHESIS WIRE (K870766)Treace Medical, Inc.1987-04-15
INCUS/STAPES PROSTHESIS (K861369)Richards Medical Co., Inc.1986-07-14
MICROTEK STAINLESS STEEL PISTON (K860460)Microtek Medical, Inc.1986-07-11
INCUS PROSTHESIS (K844961)Richards Medical Co., Inc.1985-02-26
CAUSSE SPONGE BOAT (K841353)Treace Medical, Inc.1984-07-06
DRUMTO STAPES PROSTHESIS (K832540)Humboldt Products1984-01-03
STAINLESS STEEL PISTONS (K823483)Humboldt Products1982-12-09
FISCH MODIFIED TEF-WIRE PISTON (K823429)Treace Medical, Inc.1982-12-03
MCGEE MODIFIED STAINLESS STEEL PISTON (K823440)Treace Medical, Inc.1982-12-03
CAUSSE TEF-PISTON (K823439)Treace Medical, Inc.1982-12-03
SHEA LOCKING BAIL PROSTHESIS (K802873)Richard'S Medical Equip., Inc.1980-12-19
SCHURING OSSICLE CUP & COLUMELLA PROSTH. (K802431)Richard'S Medical Equip., Inc.1980-11-12
CAUSSE MODIFIED TEFLON PISTON, OTOLOGY (K760437)Richard'S Medical Equip., Inc.1976-10-05
TRAPEZE PLATINUM RIBBON LOOP, OTOLOGY (K760434)Richard'S Medical Equip., Inc.1976-10-05
PISTON, PLATINUM TEFLON, OTOLOGY IMPLANT (K760435)Richard'S Medical Equip., Inc.1976-09-27

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