Who is the manufacturer of OTOMIMIX?

Walter Lorenz Surgical, Inc. filed the 510(k) submission for OTOMIMIX (K042516).

What is the FDA product code for OTOMIMIX?

NEA. It is classified under 21 CFR 872.3275 as a Class 2 device in the Dental panel.

What is the regulatory pathway for OTOMIMIX?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like OTOMIMIX?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

OTOMIMIX

K042516 · Walter Lorenz Surgical, Inc. · NEA · Nov 8, 2004 · Dental

Device Facts

Record ID	K042516
Device Name	OTOMIMIX
Applicant	Walter Lorenz Surgical, Inc.
Product Code	NEA · Dental
Decision Date	Nov 8, 2004
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3275
Device Class	Class 2
Attributes	Therapeutic

Intended Use

OtoMimix™ is indicated for the following: 1. Augmentation or coupling of the middle ear ossicles. 2. Attachment of the middle ear ossicles to middle ear implants. 3. Mechanical stabilization of middle ear prostheses 4. Reconstruction of the posterior canal wall

Device Story

OtoMimix™ is a sterile, two-component calcium phosphate bone replacement material used in otology procedures. The powder component (calcium phosphate and sodium citrate dihydrate) is mixed with a liquid component (anhydrous citric acid and distilled water) by the surgeon to create a moldable cement. Once applied to the surgical site, the material hardens to provide mechanical stabilization or reconstruction of the ossicular chain and posterior canal wall. Used in clinical settings by surgeons; the device functions as a bone void filler. Benefits include restoration of hearing function through ossicular chain stabilization. The device is single-use and provided sterile.

Clinical Evidence

No clinical trials were conducted for this 510(k). Substantial equivalence is based on material characterization, comparison of technological features, and cited literature (Dornhoffer et al.) demonstrating the non-ototoxicity of the calcium phosphate material.

Technological Characteristics

Two-component calcium phosphate cement. Powder: calcium phosphate, sodium citrate dihydrate. Liquid: anhydrous citric acid, distilled water. Hand-mixed. Sterile, single-use. Form factor: moldable paste that hardens in situ. No electronic or software components.

Indications for Use

Indicated for patients requiring middle ear ossicle augmentation, coupling, attachment to implants, mechanical stabilization of prostheses, or posterior canal wall reconstruction.

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Predicate Devices

Mimix (Craniofacial Calcium Phosphate Ceramic Bone Void Filler (K990290))
Oto-Cem® - OtoTech®, Inc. (K011338)
Incus Stapes Prosthesis - Richards Medical, Inc. (K861369)

Related Devices

K060750 — STRYKER INJECTABLE CEMENT · Stryker Cmf · Apr 19, 2006
K140644 — PROCEM · Ototronix, LLC · Jun 19, 2014
K080032 — ENVOYCEM, MODEL 1640 · Envoy Medical Corporation · Feb 28, 2008
K043280 — MIMIX MP BONE VOID FILLER · Biomet, Inc. · Dec 21, 2004
K041089 — OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM · Biomet Manufacturing, Inc. · Aug 31, 2004

Submission Summary (Full Text)

{0}------------------------------------------------ Summary of Safety and Effectiveness Device Name: OtoMimix™ # Classification Name and Reference: Product Code: NEA Device Classification: Class II Device Description: OtoMimix™ is a sterile calcium phosphate Bone Replacement product. When mixed with a stering solution, it becomes moldable material for use in otology procedures. With time, this moldable filler material hardens. Intended Use: OtoMimix™ is indicated for use in the following: 1. Augmentation or coupling of the middle ear ossicles. 2. Attachment of the middle ear ossicles to middle ear implants. 3. Mechanical stabilization of middle ear prostheses. 4. Reconstruction of the posterior canal wall. ## Materials Powder component - calcium phosphate powder and sodium citrate dihydrate Liquid component - anhydrous citric acid and distilled water # POSSIBLE ADVERSE EFFECTS - 1. Wound complications including hemotoma, site drainage, bone fracture, infections that are possible with any surgery. Any of these complications can lead to failure of the procedure and further surgery, - Fracture or extrusion of the filler, with or without generation of particulate debris. 2. - 3. Deformity of the bone at the surgical site. - Incomplete or lack of osseous ingrowth into bone void, as is possible with any bone void filler. 4. - ર. Implantation of foreign materials can result in an inflammatory response or allergic reaction, or subsequent cholestotoma. # Substantial Equivalence The OtoMimix10 product is believed to be substantially equivalent in application and function to Mimix (Craniofacial Calcium Phosphate Ceramic Bone Void Filler (K990290) Oto-Cem® - OtoTech®, Inc. (K011338) Incus Stapes Prosthesis - Richards Medical, Inc. (K861369) Walter Lorenz Surgical, Inc. is a wholly owned subsidiary of Biomet, Inc. The proposed OtoMinix™ product is equivalent in material characteristics and processing methods to the approved Mimix. Only packaging will change, slightly, to accommodate wolument material (0.5 to 5 grams). The anticipated size to be delivered to the market is 2 grams. The approved HA middle ear prostheses (Richards, Xomed) are composed of the same material class (hydroxyagatite) and have the same field of use (middle ear applications). The approved Oto-Cem device and the proposed OtoMinix device have an equivalent application in the cementing of ossicles of the middle ear. Based on the characteristics of these predicate devices, the safety and effectiveness of OtoMimix is assessed to be substantially equivalent to approved devices for the same intended use in restoration of hearing the function of the ossicular chain. {1}------------------------------------------------ Summary of Substantial Equivalence | | Proposed OtoMimix | Approved Oto-Cem | Approved Mimix Biomet, Inc. K 990290, K003494 | Approved Incus Stapes Prosthesis - Richards Medical Co., Inc. K861369 | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------| | Material | Calcium Phosphate cement Same as Mimix Predicate | Hybrid glass polymer composite | Calcium Phosphate cement | Subsequent HA middle ear prostheses (e.g. Xomed) No 510K summary available. | | | | | | 1st approved hydroxyapatite prosthesis known to be marketed by Richards in 1986 | | | | | | Hydroxyapatite No 510K summary available. | | Indications for use | 1. Augmentation or coupling of the middle ear ossicles. 2. Attachment of the middle ear ossicles to middle ear implants. 3. Mechanical stabilization of middle ear prostheses 4. Reconstruction of the posterior canal wall | "for use in otological surgery for reconstruction of the ossicular chain" | "...neurosurgical burr holes, craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton." | | | Contraindications | | | | No 510K summary available. | | Ototoxicity | Demonstrated to be non-ototoxic (Dornhoffer et al.) | No information available | Demonstrated to be non-ototoxic (Dornhoffer et al.) | No information available - commonly used for middle ear prostheses | | Use | Single Use | Single Use | Single Use | Single Use | | Sterility | Provided Sterile | Provided Sterile | Provided Sterile | Provided Sterile | | Technological Features | 2 component cement Hand Mixed HA material History of clinical use near dura, CSF | 2 component cement Mixing Machine Polymaleinate derived cement Contraindicated for use near nerve tissue | 2 component cement Hand Mixed HA material History of clinical use near dura, CSF | Preformed Implant No mixing required HA material Extensive history of middle ear use | {2}------------------------------------------------ 100 million in the state {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV - 8 2004 Walter Lorenz Surgical, Inc. c/o Ms. Kim Reed 1520 Tradeport Dr. Jacksonville, FL 32218 Re: K042516 Trade/Device Name: OtoMimixTM Regulation Number: 21 CFR 872.3275 Regulation Name: Ear Nose and Throat (ENT) Cement Regulatory Class: II Product Code: NEA Dated: September 15, 2004 Received: September 16, 2004 Dear Ms. Reed: We have reviewed your Section 510(k) premarket notification of intent to market the device w o no reviewed your bookear ================================================================================================================================================= referenced in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass stated in the energent date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, mainers of the Act include requirements for annual registration, listing of devices, good vanufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {4}------------------------------------------------ Page 2 - Ms. Kim Reed This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 Manufacturers, International 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 Sincerely yours. A halyi 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 {5}------------------------------------------------ # STATEMENT OF INDICATIONS FOR USE **510(k) Number** k042516 Device Name: OtoMimix™ Indications for Use: OtoMimix™ is indicated for the following: - 1. Augmentation or coupling of the middle ear ossicles. - 2. Attachment of the middle ear ossicles to middle ear implants. - 3. Mechanical stabilization of middle ear prostheses - 4. Reconstruction of the posterior canal wall Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) (Division Sign-Oll Division of Ophthalmic Ear, Nose and Throat Devises 510(k) Number K042516 Page 1 of of (Posted November 13, 2003)