POLYGRAFT BGS; BONE GRAFT SUBSTITUTE

K041382 · Osteobiologics, Inc. · JDK · Jun 17, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K041382
• Device Name: POLYGRAFT BGS; BONE GRAFT SUBSTITUTE
• Applicant: Osteobiologics, Inc.
• Product Code: JDK · General, Plastic Surgery
• Decision Date: Jun 17, 2005
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2

Intended Use

PolyGraft™ BGS Cement Restrictor is indicated for use as a bone cement flow restrictor plug in the femur, tibia, and/or humerus.

Device Story

PolyGraft™ BGS Cement Restrictor is a mechanical plug used during orthopedic surgical procedures. It is inserted into the intramedullary canal of the femur, tibia, or humerus to act as a barrier, preventing the distal migration of bone cement during joint replacement or fixation surgeries. The device is operated by a surgeon in an operating room setting. By restricting cement flow, it ensures proper pressurization and containment of the bone cement within the desired site, facilitating stable fixation of implants. The device is contraindicated for spinal applications.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical bone cement flow restrictor plug. Designed for insertion into long bones (femur, tibia, humerus). Non-active, non-implantable (in the context of permanent fixation) mechanical barrier.

Indications for Use

Indicated for use as a bone cement flow restrictor plug in the femur, tibia, and/or humerus. Not intended for any spinal indications.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 17 2005

Gabriele G. Niederauer, Ph.D. Director of Research and Development OsteoBiologics, Inc. 12500 Network, Suite 112 San Antonio, Texas 78249-3308

Document: K041382 Re: Document: 100 Tame: PolyGraft™ BGS Cement Restrictor Regulation Number: 21 CFR §878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: JDK Dated: May 20, 2005 Received: May 23, 2005

Dear Dr. Niederauer:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rowed your your your be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conimered prox to May 20, 2017 () in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls and Cosment Free (110) - Tellimitations described below. The general controls provisions of the provisions of the Actualia for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this I he Office of Doriet Eraintended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following Could Cause nami. " Inceler of the Warnings section of the device's labeling and also as a Warning on the product label:

WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS.

THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. I least note that the aconing before these limitations are modified in any way or removed from the device's labeling.

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Page 2 - Gabriele G. Niederauer, Ph.D.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/dsma/dsmamain.html.

Sincerely vours.

VCottn

Donna-Bea Tillman, Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

KO41382 510(k) Number (if known):

Device Name:

PolyGraft™ BGS Cement Restrictor

Indications For Use:

PolyGraft™ BGS Cement Restrictor is indicated for use as a bone cement flow restrictor plug in the femur, tibia, and/or humerus.

**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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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