Product Code: ETA
FDA class 2
21 CFR 874.3495
Replacement, Ossicular Prosthesis, Total
Ear, Nose, Throat
The total ossicular replacement prosthesis (TORP) is an implantable device used to reconstruct the complete ossicular chain in the middle ear when the malleus, incus, and stapes are damaged or absent, restoring sound transmission from the eardrum to the cochlea. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is ETA, regulated under 21 CFR 874.3495 in the Ear, Nose, Throat specialty. This device is designated as an implant.
510(k)s
38
FEI Numbers
24
Registration Numbers
24
Unique Applicants
24
Years Active
48
Basic Information
- Product Code
- ETA
- Device Class
- FDA class 2
- Regulation Number
- 874.3495
- 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
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Related 510(k) Clearances
This FDA classification is associated with 38 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K241269 | mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit | Jan 17, 2025 | Substantially Equivalent | MED-EL Elektromedizinische Geräte GmbH |
| K091187 | GRACE DYNAMIC TORP | Sep 14, 2009 | Substantially Equivalent | Grace Medical, Inc. |
| K083780 | SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2 | Mar 23, 2009 | Substantially Equivalent | AUDIO TECHNOLOGIES S.R.L. |
| K043375 | FISCH TITANIUM MIDDLE EAR PROSTHESES | Jan 24, 2005 | Substantially Equivalent | KARL STORZ ENDOSCOPY |
| K042503 | KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM | Oct 01, 2004 | Substantially Equivalent | HEINZ KURZ GMBH MEDIZINTECHNIK |
| K030492 | TITANIUM OSSICULAR REPLACMENT SYSTEM | Mar 03, 2003 | Substantially Equivalent | INVOTEC INTERNATIONAL, INC. |
| K002378 | MODULAR PORP AND TORP MODEL TBD | Aug 29, 2000 | Substantially Equivalent | GYRUS ENT L.L.C. |
| K001406 | HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES | Aug 08, 2000 | Substantially Equivalent | MEDNET LOCATOR, INC. |
| K001404 | GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON | Aug 08, 2000 | Substantially Equivalent | MEDNET LOCATOR, INC. |
| K001902 | BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD | Jul 10, 2000 | Substantially Equivalent | GYRUS ENT L.L.C. |
| K993583 | ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM | Nov 10, 1999 | Substantially Equivalent | STRYKER CORP. |
| K992138 | MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES | Aug 09, 1999 | Substantially Equivalent | MICROMEDICS, INC. |
| K990601 | BOJRAB MICRO-TORP, MODEL 7014-5845 | Mar 31, 1999 | Substantially Equivalent | GYRUS ENT L.L.C. |
| K981088 | MILLS COLUMELLA PROSTHESIS | Jun 05, 1998 | Substantially Equivalent | EXMOOR PLASTICS LTD. |
| K972735 | TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP) | Sep 05, 1997 | Substantially Equivalent | MEDNET LOCATOR, INC. |
| K963899 | CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1) | Aug 22, 1997 | Substantially Equivalent | EXMOOR PLASTICS LTD. |
| K972585 | AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL TUBINGEN | Aug 04, 1997 | Substantially Equivalent | HEINZ KURZ GMBH MEDIZINTECHNIK |
| K955615 | MISTEN MEDICAL TOTAL OSSICULAR REPLACEMENT PROSTHESIS | Dec 22, 1995 | Substantially Equivalent | MISTEN MEDICAL CORP. |
| K954518 | TREBAY TOTAL RECTANGULAR HEAD | Oct 27, 1995 | Substantially Equivalent | TREBAY MEDICAL CORP. |
| K952549 | RICHARDS TORP | Jul 03, 1995 | Substantially Equivalent | SMITH & NEPHEW RICHARDS, INC. |
| K950927 | HAPEX MALLEABLE TORP | Mar 21, 1995 | Substantially Equivalent | SMITH & NEPHEW RICHARDS, INC. |
| K945106 | MICROMED TOTAL REGULAR AND PARTIAL OFFSET | Nov 22, 1994 | Substantially Equivalent | MICROMED DEVELOPMENT CORP. |
| K934107 | BLACK OVAL-TOP TORP/PORP | Jun 08, 1994 | Substantially Equivalent | SMITH & NEPHEW RICHARDS, INC. |
| K913286 | H/A TOTAL-REGULAR, H/A TOTAL-OFFSET | Dec 18, 1991 | Substantially Equivalent | RIVER MEDICAL, INC. |
| K911583 | IONOS(R) OSSICLE 5MM & 7MM | Sep 09, 1991 | Substantially Equivalent | IONOS GMBH & CO. KG |
| K904239 | SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES | Jun 21, 1991 | Substantially Equivalent | MICROBIO-MEDICS, INC. |
| K895815 | MICROTEK TOTAL OSSICULAR PROTHESIS | Dec 26, 1989 | Substantially Equivalent | MICROBIO-MEDICS, INC. |
| K884884 | OSSICULAR PROSTHESIS: 8 PARTIAL, 3 TOTAL | Jun 16, 1989 | Substantially Equivalent | POREX TECHNOLOGIES CORP. OF GEORGIA |
| K885201 | OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT | Apr 19, 1989 | Substantially Equivalent | MICROBIO-MEDICS, INC. |
| K864444 | SHEA CUPPED TORP WITH HYDROXYLAPATITE FLANGE | Feb 06, 1987 | Substantially Equivalent | RICHARDS MEDICAL CO., INC. |
| K864443 | EGG-TOP TORP AND EGG-TOP PORP | Feb 02, 1987 | Substantially Equivalent | RICHARDS MEDICAL CO., INC. |
| K843461 | BIOGLASS OSSICULAR RECONSTRUCTION PROSTH | Jan 09, 1985 | Substantially Equivalent | AMERICAN BIOMATERIALS CORP. |
| K823919 | TOTAL OSSICULAR REPLACEMENT | Jun 24, 1983 | Substantially Equivalent | TREACE MEDICAL, INC. |
| K823918 | AUSTIN MODIFIED PARTIAL OSSICULAR RE- | Jun 24, 1983 | Substantially Equivalent | TREACE MEDICAL, INC. |
| K823917 | PARTIAL OSSICULAR REPLACEMENT | Jun 24, 1983 | Substantially Equivalent | TREACE MEDICAL, INC. |
| K823912 | AUSTIN MODIFIED TOTAL OSSICULAR REPLACE | Jun 24, 1983 | Substantially Equivalent | TREACE MEDICAL, INC. |
| K810707 | CERAVITAL CERAMIC OSSICULAR REPL. PROS. | Jun 16, 1981 | Substantially Equivalent | XOMED, INC. |
| K760433 | SHEA TORP, OTOLOGY IMPLANT | Oct 05, 1976 | Substantially Equivalent | RICHARD'S MEDICAL EQUIP., INC. |
FEI Numbers
This FDA classification entry is associated with 24 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 24 registration numbers. Click on an entry to view related FDA registrations.