Atlas FDA

ETA

39 FDA 510(k) clearances · Product code

86 daysmedian time to decision
268 days90th percentile
39clearances measured

FDA profile

Official device name
Replacement, Ossicular Prosthesis, Total
Device class
Class II (moderate risk)
Regulation
21 CFR 874.3495
Medical specialty
Ear, Nose, Throat
Flags
Implant
Adverse events (MAUDE)
2001: 2 · 2002: 1 · 2004: 2 · 2008: 5 · 2014: 6 · 2016: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50 (K260719)MED-EL Elektromedizinische Geräte GmbH2026-04-03
mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit (K241269)MED-EL Elektromedizinische Geräte GmbH2025-01-17
GRACE DYNAMIC TORP (K091187)Grace Medical, Inc.2009-09-14
SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2 (K083780)Audio Technologies S.R.L.2009-03-23
FISCH TITANIUM MIDDLE EAR PROSTHESES (K043375)Karl Storz Endoscopy2005-01-24
KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM (K042503)Heinz Kurz GmbH Medizintechnik2004-10-01
TITANIUM OSSICULAR REPLACMENT SYSTEM (K030492)Invotec International, Inc.2003-03-03
MODULAR PORP AND TORP MODEL TBD (K002378)Gyrus Ent LLC2000-08-29
HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES (K001406)Mednet Locator, Inc.2000-08-08
GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON (K001404)Mednet Locator, Inc.2000-08-08
BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD (K001902)Gyrus Ent LLC2000-07-10
ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM (K993583)Stryker Corp.1999-11-10
MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES (K992138)Micromedics, Inc.1999-08-09
BOJRAB MICRO-TORP, MODEL 7014-5845 (K990601)Gyrus Ent LLC1999-03-31
MILLS COLUMELLA PROSTHESIS (K981088)Exmoor Plastics , Ltd.1998-06-05
TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP) (K972735)Mednet Locator, Inc.1997-09-05
CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1) (K963899)Exmoor Plastics , Ltd.1997-08-22
AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL TUBINGEN (K972585)Heinz Kurz GmbH Medizintechnik1997-08-04
MISTEN MEDICAL TOTAL OSSICULAR REPLACEMENT PROSTHESIS (K955615)Misten Medical Corp.1995-12-22
TREBAY TOTAL RECTANGULAR HEAD (K954518)Trebay Medical Corp.1995-10-27
RICHARDS TORP (K952549)Smith & Nephew Richards, Inc.1995-07-03
HAPEX MALLEABLE TORP (K950927)Smith & Nephew Richards, Inc.1995-03-21
MICROMED TOTAL REGULAR AND PARTIAL OFFSET (K945106)Micromed Development Corp.1994-11-22
BLACK OVAL-TOP TORP/PORP (K934107)Smith & Nephew Richards, Inc.1994-06-08
H/A TOTAL-REGULAR, H/A TOTAL-OFFSET (K913286)River Medical, Inc.1991-12-18
IONOS(R) OSSICLE 5MM & 7MM (K911583)Ionos GmbH & Co. KG1991-09-09
SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES (K904239)Microbio-Medics, Inc.1991-06-21
MICROTEK TOTAL OSSICULAR PROTHESIS (K895815)Microbio-Medics, Inc.1989-12-26
OSSICULAR PROSTHESIS: 8 PARTIAL, 3 TOTAL (K884884)Porex Technologies Corp. of Georgia1989-06-16
OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT (K885201)Microbio-Medics, Inc.1989-04-19
SHEA CUPPED TORP WITH HYDROXYLAPATITE FLANGE (K864444)Richards Medical Co., Inc.1987-02-06
EGG-TOP TORP AND EGG-TOP PORP (K864443)Richards Medical Co., Inc.1987-02-02
BIOGLASS OSSICULAR RECONSTRUCTION PROSTH (K843461)American Biomaterials Corp.1985-01-09
AUSTIN MODIFIED PARTIAL OSSICULAR RE- (K823918)Treace Medical, Inc.1983-06-24
AUSTIN MODIFIED TOTAL OSSICULAR REPLACE (K823912)Treace Medical, Inc.1983-06-24
PARTIAL OSSICULAR REPLACEMENT (K823917)Treace Medical, Inc.1983-06-24
TOTAL OSSICULAR REPLACEMENT (K823919)Treace Medical, Inc.1983-06-24
CERAVITAL CERAMIC OSSICULAR REPL. PROS. (K810707)Xomed, Inc.1981-06-16
SHEA TORP, OTOLOGY IMPLANT (K760433)Richard'S Medical Equip., Inc.1976-10-05

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