AOC BONE WAX OSTENE, OSTEOTENE AND CERETENE

K052528 · Ceremed , Inc. · MTJ · Oct 11, 2005 · SU

Device Facts

• Record ID: K052528
• Device Name: AOC BONE WAX OSTENE, OSTEOTENE AND CERETENE
• Applicant: Ceremed , Inc.
• Product Code: MTJ · SU
• Decision Date: Oct 11, 2005
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

AOC Bone Wax is intended for use in the control of bleeding from bone surfaces.

Device Story

AOC Bone Wax is an odorless, opaque, wax-like material used to stop bone bleeding. It functions as a physical barrier; when applied to bone surfaces under moderate pressure, it plugs vascular openings to prevent hemorrhage. The device is supplied sterile by irradiation for single use in surgical settings. It is applied manually by surgeons or clinicians during procedures where bone is cut or traumatized. The wax is ready for use directly from the package and can be manipulated by hand to adjust consistency and stickiness. By creating a mechanical seal, it provides immediate hemostasis on bone surfaces, facilitating surgical site management.

Clinical Evidence

No clinical data provided; substantial equivalence is based on the established history of bone wax use and similarity to predicate devices.

Technological Characteristics

Odorless, opaque, wax-like material. Sterile, single-use, provided via irradiation. Mechanical barrier principle of operation. No electronic components, software, or complex materials.

Indications for Use

Indicated for the control of bleeding from bone surfaces in patients undergoing surgical procedures involving bone trauma or cutting.

Predicate Devices

• Ceremed, Inc. AOC Bone Wax (K050440, K041363)

Submission Summary (Full Text)

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OCT 1 1 2005

K052528

### Ceremed. Inc. AOC Bone Wax Special 510 (k) Submission

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

#### Submitted by:

Tadeusz Wellisz, M.D. Ceremed, Inc. 3643 Lenawee Ave. Los Angeles, California 90016 Tel: [phone] Fax: [phone]

Contact Person: Date Prepared

Common/Usual Name:

Tadeusz Wellisz, M.D. August 29, 2005

**Common/Usual Name:**

Proprietary Name:

Classification Name:

Predicate Device:

Bone Wax

AOC Bone Wax Ostene TM, Osteotene TM, Ceretene тм

Unclassified

Ceremed, Inc. AOC Bone Wax K050440, K041363

#### Description of the device:

AOC Bone Wax is an odorless, opaque wax-like material designed to be utilized directly out of the package. It is best used immediately following removal from the package, and can be softened and increased in stickiness by additional handling and manipulation, if so desired. AOC Bone Wax is provided sterile by irradiation and must not be resterilized.

Used for over 100 years, bone waxes stop bone bleeding by the creation of a physical barrier along the edges of bones that have been damaged by trauma or cut during a surgical procedure. The wax, when placed on bone under moderate pressure, plugs the vascular openings in the bone. This plug prevents further bleeding.

#### Intended use:

AOC Bone Wax is intended for use in the control of bleeding from bone surfaces.

#### Substantial equivalence:

The modified AOC Bone Wax has the same intended use fundamental scientific technology as the legally marketed AOC Bone Wax.

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OCT 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tadeusz Wellisz, M.D. President Ceremed. Inc. 3643 Lenawec Avenue Los Angeles, California 90016

Re: K052528

Trade/Device Name: AOC'" Bone Wax, Ostenc", Osteotene", Ceretene" Regulatory Class: Unclassified Product Code: MTJ Dated: September 12, 2005 Received: September 14, 2005

Dear Dr. Wellisz:

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- Tadeusz Wellisz, M.D.

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

S. Mark Mullen

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Ceremed, Inc. Special 510 (k) - AOC Bone Wax

# YII. INDICATIONS FOR USE:

510 (k) Number (if known): _KOS2526

Device Name: AOC™ Bone Wax, Ostene™, Osteotene™, Ceretene™, Ceretene TM

Indications For Use: AOC Bone Wax is indicated for use in the control of bleeding from bone surfaces.

Prescription Use ﮯ (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

200

Division Sign-Off) (Division Dig.)
Division of General, Restorative, and Neurological Devices

**510(k) Number** k052528

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