STRYKER INJECTABLE CEMENT

K060750 · Stryker Cmf · NEA · Apr 19, 2006 · Dental

Device Facts

• Record ID: K060750
• Device Name: STRYKER INJECTABLE CEMENT
• Applicant: Stryker Cmf
• Product Code: NEA · Dental
• Decision Date: Apr 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Stryker® Injectable Cement is indicated for use in the following: augmentation or coupling of the middle ear ossicles, attachment of the middle ear ossicles to middle ear implants, mechanical stabilization of middle ear prostheses, and the reconstruction of the posterior canal wall.

Device Story

Stryker® Injectable Cement is a calcium phosphate-based bone cement used in otolaryngology procedures. The device consists of a powder and liquid component that are mixed by the clinician to form a paste. This paste is then applied to the surgical site to augment or couple middle ear ossicles, attach ossicles to implants, stabilize prostheses, or reconstruct the posterior canal wall. The cement hardens in situ to provide mechanical support. It is intended for use by surgeons in a clinical or operating room setting. The device provides structural stabilization, facilitating the reconstruction of middle ear anatomy and potentially improving hearing outcomes for patients undergoing middle ear surgery.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Calcium phosphate-based bone cement. Provided sterile. Operational principle involves mixing powder and liquid components to form a paste for application. Form factor is an injectable cement.

Indications for Use

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

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

• Stryker® Injectable Cement (K060061)
• Stryker® HAC Rapid Set Cement (K043334)
• Walter Lorenz Otomimix (K042516)

Submission Summary (Full Text)

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060750

APR 1 9 2006

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS:

Stryker® Injectable Cement

#### General Information

| Proprietary Name: | Stryker® Injectable Cement |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Hydroxyapatite Cement |
| Proposed Regulatory Class: | Class II |
| Device Classification: | NEA (21 CFR 872.3275) Cement, Ear, Nose and Throat<br>FMF (21 CFR 880.5860) Syringe, Piston |
| Submitter: | Stryker®<br>4100 East Milham Avenue<br>Kalamazoo, MI 49001<br>877-534-2464 x 4226 |
| Submitter's Registration #: | 8010177 |
| Manufacturer's Registration #: | 9610726 |
| Contact Person: | Wade T. Rutkoskie<br>Manager, Regulatory Affairs and Quality Assurance<br>Phone: [phone] x 4226<br>Fax: [phone] |
| Summary Preparation Date: | March 6, 2006 |

#### Intended Use

Stryker® Injectable Cement is indicated for use in the following: augmentation or coupling of the middle ear ossicles, attachment of the middle ear ossicles to middle ear implants, mechanical stabilization of middle ear prostheses, and the reconstruction of the posterior canal wall.

#### Substantial Equivalency Information

Stryker® Injectable Cement is substantially equivalent to legally marketed K060061 Stryker® Injectable Cement, K043334 Stryker® HAC Rapid Set Cement, and K042516 Walter Lorenz Otomimix.

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| | Stryker®<br>Injectable<br>Cement<br>(PENDING) | K060061<br>Stryker<br>Injectable<br>Cement | K043334<br>Stryker®<br>HAC<br>Rapid<br>Setting<br>Cement | K<br>042561<br>Walter<br>Lorenz<br>Otomimix |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|--------------------------------------------|----------------------------------------------------------|---------------------------------------------|
| Intended Use: Stryker® Injectable Cement is<br>intended for use in the following: 1.<br>Augmentation or coupling of the middle ear<br>ossicles. 2. Attachment of the middle ear<br>ossicles to middle ear implants. 3.<br>Mechanical stabilization of the middle ear<br>prostheses. 4. Reconstruction of the<br>posterior canal wall. | √ | | | √ |
| Material: Calcium Phosphate | √ | √ | √ | √ |
| Sterility: Sterile | √ | √ | √ | √ |
| Operational Principle: Powder and liquid<br>mixed to form a paste for application | √ | √ | √ | √ |
| INJECTABLE Cement | √ | √ | | |

The primary predicate device, Stryker Injectable Cement (K060061), is identical in material formulation, physical properties, chemical composition and performance. All predicate devices share the same operational principles and are provided sterile.

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Image /page/2/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 a stylized image of an eagle with three wing-like shapes, representing the department's mission to protect the health of all Americans and provide essential human services.

#### Public Health Service . . .

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 9 2006

Stryker® c/o Mr. Wade T. Rutkoskie 750 Trade Centre Way Kalamazoo, MI 49001

Re: K060750

Trade/Device Name: Stryker® Injectable Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Cement, Ear, Nose and Throat Regulatory Class: Class II Product Code: NEA Dated: March 24, 2006 Received: March 27, 2006

Dear Mr. Rutkoskie:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment 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 controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing 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.

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### Page 2 -- Mr. Wade T. Rutkoskie

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 10(t) marketed predicate device results in a classification for your device and thus, perfocts 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 [phone]. Also, please note (1) OFF C at 001), picc "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may ahtain other general information on your responsibilities under the Act from the Division may onall Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

MB Eychards. M

Malvina B. Eydelman, M.D. Division 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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## Page 1 of 1

# 510(K) Number (if known): K O 6 0 75-0

# Device Name: Stryker® Injectable Cement

# Indications for Use:

Stryker® Injectable Cement is indicated for use in the following: augmentation or coupling of the middle ear ossicles, attachment of the middle car ossicles to middle ear implants, mechanical stabilization of middle ear prostheses, and the reconstruction of the posterior canal wall.

Prescription Use (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Posted November 13, 2003)

Analshur

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

66075(

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