← Product Code [ETA](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETA) · K043375
# FISCH TITANIUM MIDDLE EAR PROSTHESES (K043375)
_Karl Storz Endoscopy · ETA · Jan 24, 2005 · Ear, Nose, Throat · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETA/K043375
## Device Facts
- **Applicant:** Karl Storz Endoscopy
- **Product Code:** [ETA](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETA.md)
- **Decision Date:** Jan 24, 2005
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.3495
- **Device Class:** Class 2
- **Review Panel:** Ear, Nose, Throat
- **Attributes:** Therapeutic
## Intended Use
The FISCH Titanium Middle Ear Prostheses are intended for ossicle replacement to restore middle ear function when the sound transmission chain is broken. The various prosthetic models are implanted for partial or complete reconstruction, to replace missing or malformed ossicles or in secondary procedures after tumor or trauma operations.
## Device Story
FISCH Titanium Middle Ear Prostheses are surgical implants used to restore middle ear sound transmission. The device line includes stapes pistons, incus prostheses, neomalleus prostheses, and total prostheses. These are implanted by surgeons during middle ear reconstructive procedures to replace missing or malformed ossicles. The prostheses are constructed from anodized titanium, providing biocompatibility. They function as mechanical bridges within the middle ear to facilitate sound conduction. The devices are provided sterile and are intended for single use.
## Clinical Evidence
Bench testing only.
## Technological Characteristics
Materials: Anodized titanium. Design: One-piece, various lengths and diameters for stapes, incus, neomalleus, and total reconstruction. Connectivity: N/A (mechanical implant). Sterilization: Sterile, single-use.
## Regulatory Identification
A total ossicular replacement prosthesis is a device intended to be implanted for the total functional reconstruction of the ossicular chain and facilitates the conduction of sound waves from the tympanic membrance to the inner ear. The device is made of materials such as polytetrafluoroethylene, polytetrafluoroethylene with vitreous carbon fibers composite, porous polyethylene, or from a combination of these materials.
## Predicate Devices
- Stryker/Leibinger FISCH Titanium Stapes Piston ([K993583](/device/K993583.md))
- Stryker/Leibinger FISCH Titanium Incus Prosthesis ([K993583](/device/K993583.md))
- Stryker/Leibinger FISCH Titanium Neomalleus Prosthesis ([K993583](/device/K993583.md))
- Stryker/Leibinger FISCH Titanium Total Prosthesis ([K993583](/device/K993583.md))
## Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo is white and the background is black. The logo is stylized and modern.
Karl Storz Endoscopy-America, Inc. 12 1 1 1 1 1 1 11 11 800 Corporate Pointe 5th Floor Culver City, California 90230-7600 Phone 310 338 8100
Toll Free 900 421 0837 Fax 310 410 5527
K043375
#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe Drive
Culver City, CA 90230
(310) 338-8100 |
|------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Yvonne Fernandez
Sr. Regulatory Affairs Associate |
#### Device Identification:
| Common Name: | Total ossicular replacement prostheses
Partial ossicular replacement prostheses |
|--------------|------------------------------------------------------------------------------------|
| Trade Name: | FISCH Titanium Middle Ear Prostheses |
| | FISCH Titanium Total Prosthesis |
- FISCH Titanium Stapes Piston (7.0 mm, 8.5 mm. 10.0 mm)
- FISCH Titanium Incus Prosthesis (3.0 mm, 4.0 mm, 5.0 mm) .
- FISCH Titanium Neomalleus Prosthesis .
Indication: The FISCH Titanium Middle Ear Prostheses are intended for ossicle replacement to restore middle ear function when the sound transmission chain is broken. The various prosthetic models are implanted for partial or complete reconstruction, to replace missing or malformed ossicles or in secondary procedures after turnor or trauma operations.
Device Description: The FISCH Titanium Middle Ear Prostheses are made of anodized titanium, which is commonly used in medical devices for a wide range of application and has a long history of biocompatibility for human use.
Substantial Equivalence: The FISCH Titanium Middle Ear Prostheses are substantially equivalent to the predicate devices since the basic features and intended use are similar. The minor difference between the FISCH Titanium Middle Ear Prostheses and the predicate devices raise no new issues of safety and effectiveness, as these minor differences have no effect on the performance, function or intended use of the device. See Tables 1-4 for a detailed comparison.
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# TABLE 1: Stryker/Leibinger FISCH Titanium Stapes Prosthesis Comparison to Karl Storz FISCH Titanium Stapes Prosthesis
| DEVICE | STRYKER/ LEIBINGER - FISCH
TITANIUM STAPES PISTON (K993583) | | | KARL STORZ - FISCH TITANIUM
STAPES PISTON | | |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------|----------|----------|----------------------------------------------|--------|----------|
| 1. INTENDED USE | Flat band and piston prosthesis for
attachment to the malleus or incus,
inserted through the footplate of the
stapes. | | | Same | | |
| 2. DIMENSIONS BY
MODEL # | 13-18040 | 13-18042 | 13-18044 | 227510 | 227511 | 227512 |
| Overall
Length | 7.00 mm | 8.5 mm | 10.00 mm | 7.00 mm | 8.5 mm | 10.00 mm |
| Piston
Diameter | 0.4 mm | 0.4 mm | 0.4 mm | 0.4 mm | 0.4 mm | 0.4 mm |
| 3. MATERIAL | Titanium | | | Same | | |
| 4. SINGLE USE | Yes | | | Same | | |
| 5. STERILE | Yes | | | Same | | |
| 6. DESIGN
COMPARISON | One-piece design, flat loop to enable a
stable connection with the incus or
malleus. | | | Same | | |
: 上一篇:
## TABLE 2: Stryker/Leibinger FISCH Titanium Incus Prosthesis Comparison to Karl Storz FISCH Titanium Incus Prosthesis
| DEVICE | STRYKER/ LEIBINGER - FISCH
TITANIUM INCUS PROSTHESIS
(K993583) | | | KARL STORZ - FISCH TITANIUM
INCUS PROSTHESIS | | |
|-----------------------------|----------------------------------------------------------------------------|----------|----------|-------------------------------------------------|--------|--------|
| 1. INTENDED USE | Incus replacement to connect malleus
and head of stapes. | | | Same | | |
| 2. DIMENSIONS BY
MODEL # | 13-18030 | 13-18031 | 13-18032 | 227515 | 227516 | 227517 |
| Length | 3.00 mm | 4.0 mm | 5.0 mm | 3.00 mm | 4.0 mm | 5.0 mm |
| OD | 2.0 mm | 2.0 mm | 2.0 mm | 2.0 mm | 2.0 mm | 2.0 mm |
| OD - Tapered
End | 1.3 mm | 1.3 mm | 1.3 mm | 1.3 mm | 1.3 mm | 1.3 mm |
| 3. MATERIAL | Titanium | | | Anodized Titanium | | |
| 4. SINGLE USE | Yes | | | Same | | |
| 5. STERILE | Yes | | | Same | | |
| 6. DESIGN
COMPARISON | Design allows intraoperative shaping; 4
holes to pick up and manipulate | | | Same | | |
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# TABLE 3: Stryker/Leibinger FISCH Titanium Neomalleus Prosthesis Comparison to Karl Storz FISCH Titanium Neomalleus Prosthesis
| DEVICE | STRYKER/LEIBINGER - FISCH
TITANIUM NEOMALLEUS
PROSTHESIS (K993583) | KARL STORZ- FISCH
TITANIUM NEOMALLEUS
PROSTHESIS |
|-----------------------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| 1. INTENDED USE | Malleus replacement in combination
with the stapes prosthesis. | Same |
| 2. DIMENSIONS BY MODEL
# | 13-18020 | 227522 |
| Length | 5.0 mm | 5.0 mm |
| OD - Grooved End | 1.1 mm | 1.1 mm |
| OD - Smooth End | 0.5 mm | 0.5 mm |
| 3. MATERIAL | Titanium | Anodized Titanium |
| 4. SINGLE USE | Yes | Same |
| 5. STERILE | Yes | Same |
| 6. DESIGN COMPARISON | Smooth end for insertion with the
traga perichondrium; grooves for
attachment to stapes piston | Same |
# TABLE 4: Stryker/Leibinger FISCH Titanium Total Prosthesis Comparison to Karl Storz FISCH Titanium Total Prosthesis
| DEVICE | STRYKER/LEIBINGER - FISCH TITANIUM
TOTAL PROSTHESIS (K993583) | KARL STORZ- FISCH
TITANIUM TOTAL
PROSTHESIS |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| 1. INTENDED USE | Plate prosthesis with shaft and shoe as
replacement between the tympanic
membrane and the footplate of the
stapes. | Same |
| 2. DIMENSIONS BY MODEL
# | 13-18090 | 227520 |
| Length | 10.0 mm | Same |
| Shaft Diameter | 0.6 mm | Same |
| Head Plate
Diameter | 5 mm | Same |
| 3. MATERIAL | Titanium | Anodized Titanium |
| 4. SINGLE USE | Yes | Same |
| 5. STERILE | Yes | Same |
| 6. DESIGN COMPARISON | Direct connection between tympanic
membrane and footplate; may be trimmed
to size; spike on foot for stable attachment | Same |
Signed: Yvonne Fernandez / Sr. Regulatory Affairs Associate
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
JAN 2 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Karl Storz Endoscopy- America, Inc. c/o Ms. Yvonne Fernandez Sr. Regulatory Affairs Associate 600 Corporate Pointe, 5th Floor Culver City, CA 902307
Re: K043375
K043375
Trade/Device Name: FISCH Titanium Middle Ear Prostheses
Trade/Device Name: FISCH Titanium Middle Ear Prostheses
Sublice Name: FISCH SED CER 2405 - 874 3450 I rade/Device Name: 115677 874.3495; 874.3450 Regulation Number: 21 CFR 874.3495; 874.5450
Regulation Name: Total ossicular replacement prostheses; Partial ossicular replacement prostheses Regulatory Class: Class II Product Code: ETA; ETB Dated: December 7, 2004 Received: December 8, 2004
Dear Ms. Fernandez:
We have reviewed your Section 510(k) premarket notification of intent to market the device is We have reviewed your Section 5 IQC) premises in their views on the indications
referenced above and have device is substantially equivalent (for the indications referenced above and have device is substantialey of one of one of the marketed in interstate
for use stated in the enclosure) to legally marketed in interstate for use stated in the enclosure) to legally markets device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Medical Food, Drug. commerce prior to May 28, 1976, the enacument with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the Appl devices that have been reclassified in accordance will the proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act. The and Cosmetic Act (Act) that do not require approval or the general controls of the Act. The
You may, therefore, market the device, subject to the general controls of listin You may, therefore, market the device, subject of the general connul registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act include requirements as the more of the superior misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
ed in the support the same to the Fixisting major regulations affecti If your device is classified (see above) nito entile) eass if epenlations affecting your device can
may be subject to such additional controls. Existing major regulations af may be subject to such additional conrois: Listing major regal to 898 In addion, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 be found in the Code of Federal Regulations, This DS, Andrewing your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not nean Please be advised that FDA's issuance of a substance of the requirements of the Act
that FDA has made a determination that your device compliss with other requirements of You that FDA has made a delermination inal your areas by other Federal agencies. You music or any Federal statutes and regulations administed by rot limited to: registration and listing.
comply with all the Act's requirements, including and manufactures and comply with all the Act's requirements, including, out not horses and one organizements as set
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requ (21 CFR Part 807); labeling (21 CFR Patt 801); good managf applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, 1050. forth in the quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000
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Page 2 - Ms. Yvonne Fernandez
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in yourse finding of substantial equivalence of your device to a legally promatics notification on or cassification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general michination and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincercly yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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043375
### Indications for Use
510(k) Number (if known): Not yet assigned
#### FISCH Titanium Middle Ear Prostheses Device Name:
The FISCH Titanium Middle Ear Prostheses are intended for Indications for Use: Indications for USe: ossicle replacement to restore inicule early in partial or completed broken. The vanous prosince models are implanted or in secondary procedures
reconstruction, to replace missing or malformed ossicles or in secondary procedures after tumor or trauma operations.
Prescription Use _ × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page __ of ___ (Posted November 13, 2003) 00004 Division of Of
Division of Th 510(k) Number
---
**Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETA/K043375](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ETA/K043375)
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