POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX

K033707 · Osteobiologics, Inc. · MQV · Aug 16, 2004 · Orthopedic

Device Facts

• Record ID: K033707
• Device Name: POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX
• Applicant: Osteobiologics, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Aug 16, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3045
• Device Class: Class 2

Intended Use

The PolyGraft™ TCP 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™ TCP 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.

Device Story

PolyGraft™ TCP is a resorbable bone void filler composed of poly(D,L-lactide-co-glycolide), tricalcium phosphate, polyglycolide fibers, and surfactant. Provided in various shapes and sizes, including porous granules and preformed cylindrical plugs. Used by surgeons to fill non-structural osseous defects resulting from trauma or surgery in the extremities, spine, and pelvis. The material is packed into the defect site, where it resorbs over time and is replaced by natural bone during the healing process.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including biocompatibility assessments and in vitro degradation studies in simulated body fluid.

Technological Characteristics

Composition: poly(D,L-lactide-co-glycolide), tricalcium phosphate, polyglycolide fibers, and surfactant. Form factor: porous granules and preformed cylindrical plugs. Resorbable calcium salt bone void filler. Class II 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. Not for use in load-bearing applications.

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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## AUG 1 6 2004

#### 510(k) SUMMARY

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

| Date of Summary: | November 25, 2003 |
|------------------------|------------------------------------------------------------------------------------------------------------|
| Revised: | August 11, 2004 |
| Common Name: | Resorbable Bone Void Filler |
| Proprietary Name: | PolyGraft™ TCP |
| Device Classification: | Resorbable calcium salt bone void filler (Product Code<br>87MQV) is a Class II device, per 21 CFR 888.3045 |
| 510(k) Number: | K033707 |

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

Intended Use: The PolyGraft™ TCP 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™ TCP 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.

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

Biocompatibility assessment performed by independent certified laboratories Testing: demonstrated the biocompatibility of the materials used for this device. Degradation testing performed in a simulated body fluid at 37 ℃ showed that the degradation rate is substantially equivalent to the predicate devices. The results from this side-by-side in vitro comparison demonstrated that PolyGraft™ TCP are substantially equivalent to the predicate devices, therefore supporting the suitability of the PolyGraft™ TCP for use in a clinical situation.

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Image /page/1/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the border of the circle. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 6 2004

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

Re: K033707

Trade Name: PolyGraft TCP Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MQV Dated: July 22, 2004 Received: July 23, 2004

Dear Dr. Niederauer:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your early and 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 merslate commerce prior to have been reclassified in accordance with the provisions of Amendinens, or to de roses 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 upprovisions of the Act. The general controls provisions of the Act include controls providents of a 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 (1 Writ), it may of our in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal 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 mour that I Dr. Federal statutes and regulations administered by other Federal agencies. or the ret 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 and fisting (21 CFR rath in the quality systems (QS) regulation (21 CFR Part 820); and if

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

applicable, 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 510(k) This feter will anony of Jo The FDA finding of substantial equivalence of your device to a premiurker notification - I - 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), 11 you don't 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 may obtain 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.

Mark N Millkerson

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

#### 510(k) Number (if known): K033707

Device Name: PolyGraft™ TCP

#### Indications for Use:

The PolyGraft™ TCP is to be used to fill bony voids or gaps caused by trauma on surgery that are not intrinsic to the stability of the bony structure. The PolyGraft™ TCP surgery that are not internet to the bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous extremities, spino and pents/eated from traumatic injury to the bone. The product ucinots or occouds and is resorbs and is replaced with bone during the healing process.

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)

l Mark N. Millhuser

. Restorative, and Neurological Devices

) Number K033707

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