Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

ETA — Predicate Candidate Screening

39 FDA 510(k) clearances under this product code; the 50 most recent screened below.

86 daysmedian FDA review time

268 days90th percentile

39clearances measured

K-number	Device	Applicant	Decided	Review days
K260719	mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosth	MED-EL Elektromedizinische Geräte GmbH	2026-04-03	29
K241269	mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Cen	MED-EL Elektromedizinische Geräte GmbH	2025-01-17	268
K091187	GRACE DYNAMIC TORP	Grace Medical, Inc.	2009-09-14	144
K083780	SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABL	Audio Technologies S.R.L.	2009-03-23	94
K043375	FISCH TITANIUM MIDDLE EAR PROSTHESES	Karl Storz Endoscopy	2005-01-24	47
K042503	KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63	Heinz Kurz GmbH Medizintechnik	2004-10-01	16
K030492	TITANIUM OSSICULAR REPLACMENT SYSTEM	Invotec International, Inc.	2003-03-03	12
K002378	MODULAR PORP AND TORP MODEL TBD	Gyrus Ent LLC	2000-08-29	25
K001406	HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REP	Mednet Locator, Inc.	2000-08-08	97
K001404	GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLAC	Mednet Locator, Inc.	2000-08-08	97
K001902	BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD	Gyrus Ent LLC	2000-07-10	18
K993583	ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM	Stryker Corp.	1999-11-10	19
K992138	MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND A	Micromedics, Inc.	1999-08-09	46
K990601	BOJRAB MICRO-TORP, MODEL 7014-5845	Gyrus Ent LLC	1999-03-31	35
K981088	MILLS COLUMELLA PROSTHESIS	Exmoor Plastics , Ltd.	1998-06-05	72
K972735	TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP)	Mednet Locator, Inc.	1997-09-05	45
K963899	CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1)	Exmoor Plastics , Ltd.	1997-08-22	329
K972585	AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRES	Heinz Kurz GmbH Medizintechnik	1997-08-04	25
K955615	MISTEN MEDICAL TOTAL OSSICULAR REPLACEMENT PROSTHESIS	Misten Medical Corp.	1995-12-22	11
K954518	TREBAY TOTAL RECTANGULAR HEAD	Trebay Medical Corp.	1995-10-27	29
K952549	RICHARDS TORP	Smith & Nephew Richards, Inc.	1995-07-03	31
K950927	HAPEX MALLEABLE TORP	Smith & Nephew Richards, Inc.	1995-03-21	20
K945106	MICROMED TOTAL REGULAR AND PARTIAL OFFSET	Micromed Development Corp.	1994-11-22	35
K934107	BLACK OVAL-TOP TORP/PORP	Smith & Nephew Richards, Inc.	1994-06-08	289
K913286	H/A TOTAL-REGULAR, H/A TOTAL-OFFSET	River Medical, Inc.	1991-12-18	147
K911583	IONOS(R) OSSICLE 5MM & 7MM	Ionos GmbH & Co. KG	1991-09-09	154
K904239	SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES	Microbio-Medics, Inc.	1991-06-21	281
K895815	MICROTEK TOTAL OSSICULAR PROTHESIS	Microbio-Medics, Inc.	1989-12-26	88
K884884	OSSICULAR PROSTHESIS: 8 PARTIAL, 3 TOTAL	Porex Technologies Corp. of Georgia	1989-06-16	206
K885201	OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT	Microbio-Medics, Inc.	1989-04-19	124
K864444	SHEA CUPPED TORP WITH HYDROXYLAPATITE FLANGE	Richards Medical Co., Inc.	1987-02-06	86
K864443	EGG-TOP TORP AND EGG-TOP PORP	Richards Medical Co., Inc.	1987-02-02	82
K843461	BIOGLASS OSSICULAR RECONSTRUCTION PROSTH	American Biomaterials Corp.	1985-01-09	126
K823918	AUSTIN MODIFIED PARTIAL OSSICULAR RE-	Treace Medical, Inc.	1983-06-24	178
K823912	AUSTIN MODIFIED TOTAL OSSICULAR REPLACE	Treace Medical, Inc.	1983-06-24	178
K823917	PARTIAL OSSICULAR REPLACEMENT	Treace Medical, Inc.	1983-06-24	178
K823919	TOTAL OSSICULAR REPLACEMENT	Treace Medical, Inc.	1983-06-24	178
K810707	CERAVITAL CERAMIC OSSICULAR REPL. PROS.	Xomed, Inc.	1981-06-16	92
K760433	SHEA TORP, OTOLOGY IMPLANT	Richard'S Medical Equip., Inc.	1976-10-05	50

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