Product Code: ETB FDA class 2 21 CFR 874.3450

Prosthesis, Partial Ossicular Replacement

Ear, Nose, Throat

The partial ossicular replacement prosthesis (PORP) is an implantable device used in middle ear surgery to restore the ossicular chain when only part of the chain is missing or damaged, bridging between the remaining stapes or footplate and the tympanic membrane or manubrium. It is classified as FDA Class 2, requiring 510(k) premarket clearance. The product code is ETB, regulated under 21 CFR 874.3450 in the Ear, Nose, Throat specialty. This device is designated as an implant.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: ETB
Device Class: FDA class 2
Regulation Number: 874.3450
Medical Specialty: Ear, Nose, Throat
Review Panel: EN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 74 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260720	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);	Apr 03, 2026	Substantially Equivalent	MED-EL Elektromedizinische Geräte GmbH
K260718	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)	Apr 03, 2026	Substantially Equivalent	MED-EL Elektromedizinische Geräte GmbH
K241261	mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit	Jan 17, 2025	Substantially Equivalent	MED-EL Elektromedizinische Geräte GmbH
K241142	mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis	Jan 17, 2025	Substantially Equivalent	MED-EL Elektromedizinische Geräte GmbH
K130512	NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS	Dec 02, 2013	Substantially Equivalent	Heinz Kurz GmbH Medizintechnik
K112616	NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS	Feb 08, 2013	Substantially Equivalent	Heinz Kurz GmbH Medizintechnik
K080070	K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES	Apr 17, 2008	Substantially Equivalent	Grace Medical, Inc.
K063374	NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE	Dec 06, 2006	Substantially Equivalent	Grace Medical, Inc.
K061853	GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES	Aug 18, 2006	Substantially Equivalent	Grace Medical, Inc.
K060518	PARTIAL OSSICULAR REPLACEMENT PROSTHESES	Jun 28, 2006	Substantially Equivalent	Grace Medical, Inc.
K033554	SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS	Nov 24, 2003	Substantially Equivalent	Gyrus Ent LLC
K021479	CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861	May 21, 2002	Substantially Equivalent	Heinz Kurz GmbH Medizintechnik
K013573	CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257	Nov 09, 2001	Substantially Equivalent	Heinz Kurz GmbH Medizintechnik
K010442	KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652	Mar 08, 2001	Substantially Equivalent	Heinz Kurz
K003214	SMITH & NEPHEW PISTONS	Oct 31, 2000	Substantially Equivalent	Gyrus Ent LLC
K002737	SMITH & NEPHEW PORPS & TORPS	Oct 12, 2000	Substantially Equivalent	Gyrus Ent LLC
K002897	TITANIUM MIDDLE EAR PROSTHESES	Oct 11, 2000	Substantially Equivalent	Xomed, Inc.
K002464	SMITH & NEPHEW OFF-CENTERED PORP	Aug 29, 2000	Substantially Equivalent	Gyrus Ent LLC
K002221	KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170	Aug 09, 2000	Substantially Equivalent	Heinz Kurz GmbH Medizintechnik
K001142	AUDIO TECHNOLOGIES S:R.1	Jun 23, 2000	Substantially Equivalent	Audio Technologies S.R.L.
K000858	WEHRS INCUS-STAPES	Apr 03, 2000	Substantially Equivalent	Gyrus Ent LLC
K000256	CAP PORP, CAP TORP	Feb 11, 2000	Substantially Equivalent	Gyrus Ent LLC
K993234	MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS	Nov 10, 1999	Substantially Equivalent	Micromedics, Inc.
K992839	SOCKET STAPES PISTON W/O LOOP, SCHOBEL, SCHOBEL-CAUSSE	Sep 16, 1999	Substantially Equivalent	Heinz Kurz GmbH Medizintechnik
K991394	STAPES PROSTHESES	May 18, 1999	Substantially Equivalent	Grace Medical, Inc.
K990923	TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 & BELL 1002 010	Mar 31, 1999	Substantially Equivalent	Heinz Kurz
K981045	EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS	May 20, 1998	Substantially Equivalent	Exmoor Plastics , Ltd.
K974365	MILLS INCUS HA SLEEVE	Jan 22, 1998	Substantially Equivalent	Exmoor Plastics , Ltd.
K973356	K-PISTON WITH BAND HOOK /ANGULAR PISTON	Nov 21, 1997	Substantially Equivalent	Heinz Kurz
K972815	PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT	Oct 08, 1997	Substantially Equivalent	Grace Medical, Inc.
K972737	CAUSSE PISTON	Sep 05, 1997	Substantially Equivalent	Mednet Locator, Inc.
K972734	PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP)	Sep 05, 1997	Substantially Equivalent	Mednet Locator, Inc.
K972492	BELL PROSTHESIS (PARTIAL)	Aug 04, 1997	Substantially Equivalent	Heinz Kurz
K964909	ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS	Mar 10, 1997	Substantially Equivalent	Xomed, Inc.
K962564	RICHARDS TOTAL/PARTIAL PROSTHESIS	Jan 22, 1997	Substantially Equivalent	Gyrus Ent LLC
K964798	PARTIAL OSSICULAR REPLACEMENT PROSTHESIS	Jan 02, 1997	Substantially Equivalent	Anthony D. Prescott
K963752	PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS	Oct 10, 1996	Substantially Equivalent	Grace Medical, Inc.
K945105	POLY/PLATINUM WIRE PISTON	May 14, 1996	Substantially Equivalent	Micromed Development Corp.
K955613	MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS	Dec 22, 1995	Substantially Equivalent	Misten Medical Corp.
K954517	TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT	Oct 27, 1995	Substantially Equivalent	Trebay Medical Corp.
K952481	RICHARDS PORP	Jun 16, 1995	Substantially Equivalent	Smith & Nephew Richards, Inc.
K950984	HAPES MALLEABLE INCUS STAPES	Mar 15, 1995	Substantially Equivalent	Smith & Nephew Richards, Inc.
K950887	HAPEX INCUS	Mar 15, 1995	Substantially Equivalent	Smith & Nephew Richards, Inc.
K950886	HAPEX PORP	Mar 15, 1995	Substantially Equivalent	Smith & Nephew Richards, Inc.
K950885	HAPEX MALLEABLE PORP	Mar 15, 1995	Substantially Equivalent	Smith & Nephew Richards, Inc.
K945108	POLY PISTON	Nov 22, 1994	Substantially Equivalent	Micromed Development Corp.
K945107	POLY-WIRE PISTON	Nov 22, 1994	Substantially Equivalent	Micromed Development Corp.
K945104	MICROMED PARTIAL REGULAR AND PARTIAL OFFSET	Nov 22, 1994	Substantially Equivalent	Micromed Development Corp.
K925443	INCUDOSTAPEDIAL JOINT	Mar 08, 1993	Substantially Equivalent	Smith & Nephew Richards, Inc.
K915120	TEF/PLATINUM PISTON	Dec 27, 1991	Substantially Equivalent	River Medical, Inc.
K915121	TEF/WIRE PISTON	Dec 23, 1991	Substantially Equivalent	River Medical, Inc.
K913287	H/A PARTIAL - REGULAR & H/A PARTIAL - OFFSET	Dec 18, 1991	Substantially Equivalent	River Medical, Inc.
K913285	PTFE PISTON	Dec 18, 1991	Substantially Equivalent	River Medical, Inc.
K910685	WEHRS INCUS AND INCUS-STAPES PROSTHESES	Dec 04, 1991	Substantially Equivalent	Smith & Nephew Richards, Inc.
K913619	CERAVITAL MIDDLE EAR IMPLANT	Oct 15, 1991	Substantially Equivalent	Friedrichsfeld Medizintechnik AG
K895814	MICROTEK PISTON & WIRE PROSTHESES	Dec 26, 1989	Substantially Equivalent	Microbio-Medics, Inc.
K893134	APACERAM OSSICULAR PROSTHESIS	Aug 03, 1989	Substantially Equivalent	Asahi Optical Co. C/O Rosati Associates, P.C.
K883727	BUCKET PROSTHESIS PORP	Jan 13, 1989	Substantially Equivalent	Treace Medical, Inc.
K872112	XOMED PLATINUM WIRE TEFLON PISTION	Jul 02, 1987	Substantially Equivalent	Xomed, Inc.
K870766	PROSTHESIS WIRE	Apr 15, 1987	Substantially Equivalent	Treace Medical, Inc.
K861369	INCUS/STAPES PROSTHESIS	Jul 14, 1986	Substantially Equivalent	Richards Medical Co., Inc.
K860460	MICROTEK STAINLESS STEEL PISTON	Jul 11, 1986	Substantially Equivalent	Microtek Medical, Inc.
K844961	INCUS PROSTHESIS	Feb 26, 1985	Substantially Equivalent	Richards Medical Co., Inc.
K841353	CAUSSE SPONGE BOAT	Jul 06, 1984	Substantially Equivalent	Treace Medical, Inc.
K832540	DRUMTO STAPES PROSTHESIS	Jan 03, 1984	Substantially Equivalent	Humboldt Products
K823483	STAINLESS STEEL PISTONS	Dec 09, 1982	Substantially Equivalent	Humboldt Products
K823440	MCGEE MODIFIED STAINLESS STEEL PISTON	Dec 03, 1982	Substantially Equivalent	Treace Medical, Inc.
K823439	CAUSSE TEF-PISTON	Dec 03, 1982	Substantially Equivalent	Treace Medical, Inc.
K823429	FISCH MODIFIED TEF-WIRE PISTON	Dec 03, 1982	Substantially Equivalent	Treace Medical, Inc.
K802873	SHEA LOCKING BAIL PROSTHESIS	Dec 19, 1980	Substantially Equivalent	Richard'S Medical Equip., Inc.
K802431	SCHURING OSSICLE CUP & COLUMELLA PROSTH.	Nov 12, 1980	Substantially Equivalent	Richard'S Medical Equip., Inc.
K760437	CAUSSE MODIFIED TEFLON PISTON, OTOLOGY	Oct 05, 1976	Substantially Equivalent	Richard'S Medical Equip., Inc.
K760434	TRAPEZE PLATINUM RIBBON LOOP, OTOLOGY	Oct 05, 1976	Substantially Equivalent	Richard'S Medical Equip., Inc.
K760435	PISTON, PLATINUM TEFLON, OTOLOGY IMPLANT	Sep 27, 1976	Substantially Equivalent	Richard'S Medical Equip., Inc.