POLYGRAFT BGS; BONE GRAFT SUBSTITUTE

K040047 · Osteobiologics, Inc. · MQV · Dec 17, 2004 · Orthopedic

Device Facts

• Record ID: K040047
• Device Name: POLYGRAFT BGS; BONE GRAFT SUBSTITUTE
• Applicant: Osteobiologics, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Dec 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PolyGraft™ BGS is to be used to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. The PolyGraft™ BGS is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or os the offects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. The PolyGraft™ RGS may he combined with autogenous blood products, such as platelet rich plasma, and/or sterile fluids, such as saline or Ringer's solution. The addition of these autogenous products does not alter the performance of the device.

Device Story

PolyGraft™ BGS is a resorbable bone void filler; composed of poly(D,L-lactide-coglycolide), calcium sulfate, polyglycolide fibers, and surfactant. Provided as porous granules or preformed cylindrical plugs. Used by surgeons to fill non-structural bony voids in extremities, spine, and pelvis. Device is packed into defects; resorbs over time and is replaced by natural bone. Can be mixed with autogenous blood products (e.g., platelet-rich plasma) or sterile fluids (saline/Ringer's) without altering performance. Benefits patient by providing scaffold for bone healing in traumatic or surgical defects.

Clinical Evidence

Bench testing included biocompatibility assessment and degradation testing in simulated body fluid at 37°C, showing equivalence to predicate. In vivo evidence provided by a rabbit metaphyseal defect study comparing PolyGraft™ BGS with autogenous blood products against the predicate (PolyGraft™ BGS alone). Histological analysis demonstrated similar bone formation at various endpoints, supporting substantial equivalence for the expanded indications.

Technological Characteristics

Resorbable calcium salt bone void filler. Materials: poly(D,L-lactide-coglycolide), calcium sulfate, polyglycolide fibers, surfactant. Form factor: porous granules or preformed cylindrical plugs. Resorption mechanism: material resorbs and is replaced by bone. Non-electronic, non-software device.

Indications for Use

Indicated for filling bony voids or gaps in the skeletal system (extremities, spine, pelvis) caused by trauma or surgery that are not intrinsic to bony stability. Suitable for surgically created or traumatic osseous defects. May be used with autogenous blood products or sterile fluids.

Regulatory Classification

Identification

A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.

Predicate Devices

• PolyGraft™ BGS (K030288)

Submission Summary (Full Text)

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KD40047

# DEC 17 2004

## 510(k) SUMMARY

| Submitter | Contact |
|----------------------------------|--------------------------------------|
| Image: OBI Logo | Gabriele G. Niederauer, Ph.D. |
| OsteoBiologics, Inc. | Director of Research and Development |
| 12500 Network, Suite 112 | Phone: [phone] (ext. 228) |
| San Antonio, Texas 78249,<br>USA | Fax: [phone] |
| | E-mail: [e-mail] |

| Date of Summary: | January 9, 2004 |
|------------------------|---------------------------------------------------------------------------------------------------------|
| Revised: | November 16, 2004 |
| Common Name: | Resorbable Bone Void Filler |
| Proprietary Name: | PolyGraft™ BGS |
| Device Classification: | Resorbable calcium salt bone void filler (Product Code 87MQV) is a Class II device, per 21 CFR 888.3045 |
| 510(k) Number: | K040047 |

Description of Device: PolyGraft™ BGS is manufactured using a blend of poly(D,L-lactide-coglycolide), calcium sulfate, polyglycolide fibers and surfactant. The PolyGrafi™ BGS will be provided in a variety of shapes and sizes ranging from small, porous granules to preformed cylindrical plugs.

Intended Use: The PolyGraft™ BGS is to be used to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. The PolyGraft™ BGS is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or os the offects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. The PolyGraft™ RGS may he combined with autogenous blood products, such as platelet rich plasma, and/or sterile fluids, such as saline or Ringer's solution. The addition of these autogenous products does not alter the performance of the device.

Substantial Equivalence: The PolyGraft™ BGS is substantially equivalent in design, function and performance to the PolyGraft™ BGS cleared as K030288 on July 17, 2003.

Testing: Biocompatibility assessment performed by independent certified laboratories demonstrated the biocompatibility of the materials used for this device. Degradation testing performed in a simulated body fluid at 37° C showed that the degradation rate is substantially equivalent to the predicate devices. OsteoBiologics performed a rabbit metaphyseal defect study to compare the bone formation of the PolyGraft™ BGS to the predicate device. The PolyGrafi™ BGS combined with autogenous blood products histologically showed bone formation similar to the predicate device (PolyGraft™ BGS alone) at different endpoints. The result from this sideby-side in vivo comparison demonstrated the expanded indications that PolyGraff™ BGS in combination with autogenous blood products are substantially equivalent to PolyGraft™ BGS alone, therefore supporting the suitability of the PolyGraft™ BGS combined with autogenous blood products for use in a clinical situation.

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Public Health Service

Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 2004

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

Re: K040047

Trade Name: PolyGraft BGS Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: November 15, 2004 Received: November 16, 2004

Dear Dr. Niederauer:

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

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

manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 manufacturing practicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section This letter will anow you to ough inding of substantial equivalence of your device 510(x) prematical 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), If you desire specific at no row pliance 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 Inter other 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 yours,

Sincerely, yours,

Mark A. Mulkern

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use (Form)

#### INDICATIONS FOR USE

#### 510(K) Number (if known): K040047

#### Device Name:

## PolyGraft™ BGS (Bone Graft Substitute)

#### Indications for Use:

The PolyGraft™ BGS is to be used to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. The PolyGraff™ BGS is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. The PolyGraft™ BGS may be combined with autogenous blood products, such as platelet rich plasma, and/or sterile fluids, such as saline or Ringer's solution. The addition of these autogenous products does not alter the performance of the device.

Prescription Use X (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)

R. Mark N. Milliken

and Neurologic

510(k) Numbe

K040047

510(k) Premarket Notification: PolyGraft™ BGS - Expanded Claims

Confidential