TRUGRAFT BGS SYRINGE, MODEL 600-041

K043172 · Osteobiologics, Inc. · FMF · Jan 7, 2005 · General Hospital

Device Facts

• Record ID: K043172
• Device Name: TRUGRAFT BGS SYRINGE, MODEL 600-041
• Applicant: Osteobiologics, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Jan 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Intended Use

The TruGraft™ BGS Syringe is intended for use as a piston syringe for the aspiration of fluids, such as autologous blood, plasma or other blood components. The TruGrafi™ Syringe provides the surgeon with a convenient way to mix autologous blood with the PolyGraft® BGS. PolyGraft® TCP or other bone graft substitute and deliver the material to the orthopaedic surgical site. PolyGraft® BGS and PolyGrafi® TCP are intended 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® material 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

TruGraft™ BGS Syringe is a manual piston syringe consisting of a barrel, plunger, and removable end cap; distal end is threaded for adapter connection. Device functions as a delivery system for bone graft substitutes (e.g., PolyGraft® BGS or TCP); allows aspiration of autologous blood/plasma for mixing with graft material. Used by surgeons in orthopaedic surgical settings to pack graft material into osseous defects. Benefits include convenient mixing and delivery of bone void fillers to skeletal sites. No electronic or automated components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual piston syringe; components include barrel, plunger, and removable end cap. Distal end is threaded for adapter attachment. Materials are standard medical-grade plastics. No energy source, software, or electronic components.

Indications for Use

Indicated for aspiration of fluids (autologous blood, plasma, blood components) and delivery of preloaded bone graft substitutes to fill bony voids or gaps in the skeletal system (extremities, spine, pelvis) caused by trauma or surgery not intrinsic to bony stability.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

• Imbibe™ Bone Marrow Aspiration Syringe (K011087)
• IMBIBETM II Syringe (K030208)
• Vitoss®-Filled Cartridge (K032130)

Reference Devices

• PolyGraft® BGS (K030288)
• PolyGraft® TCP (K033707)

Submission Summary (Full Text)

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K043172

## JAN - 7 2005

510 (k) SUMMARY

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

| Date of Summary: | November 15, 2004 |
|------------------------|--------------------------------------------------------------------------------------------------------------|
| Common Name: | Kit: Bone Void Filler and Bone Graft Delivery<br>Syringe |
| Proprietary Name: | TruGraft™ BGS Syringe |
| Device Classification: | Filler, Calcium Sulfate Preformed Pellets (Product<br>Code MQV) is a Class II device, per 21 CFR<br>888.3045 |

## 510(k) Number:

Description of Device: The TruGraft™ BGS Syringe is a device that can be filled with OsteoBiologics, Inc. products: PolyGraft® BGS or PolyGraft® TCP (K030288 and K033707 respectively) or other bone graft substitute. The TruGrafTM BGS Syringe can be provided as a kit configuration. The convenience kit provides the TruGrafTM BGS Syringe loaded (filled) with a variety of bone graft substitutes.

The TruGrafi™ BGS Syringe is a standard piston syringe that consists of a barrel, plunger and removable end cap. The distal end of the barrel is threaded to allow connection to adapters. While without the attachment, the open end allows for filling of the bone graft material. A cap is available to seal the end of the barrel, enclosing the syringe contents. The piston/plunger assembly is used to expel contents or facilitate in the collection into the barrel of the syringe.

Intended Use: The TruGraft™ BGS Syringe is intended for use as a piston syringe for the aspiration of fluids, such as autologous blood, plasma or other blood components. The TruGrafi™ Syringe provides the surgeon with a convenient way to mix autologous blood with the PolyGraft® BGS. PolyGraft® TCP or other bone graft substitute and deliver the material to the orthopaedic surgical site. PolyGraft® BGS and PolyGrafi® TCP are intended 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® material 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 TruGrafi™ BGS Syringe is substantially equivalent in design, function, and performance to the Imbibe™ Bone Marrow Aspiration Syringe [K011087] on Sep 19, 2001, IMBIBETM II Syringe [K030208] and Vitoss®-Filled Cartridge [K032130].

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

JAN - 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K043172

Trade/Device Name: TruGraft™ BGS Syringe Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV, FMF Dated: November 15, 2004 Received: November 26, 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 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 - Gabriele G. Niederauer, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mo loter with action. The FDA finding of substantial equivalence of your device to a legally premaince noticated 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/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

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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## 2.4 Indications for Use (Form)

## INDICATIONS FOR USE

510(k) Number (if known):

Device Name: TruGrafi™ BGS Syringe

Indications For Use:

TruGraft™ BGS Syringe is indicated for the aspiration of fluids, such as autologous blood, plasma or other blood components with preloaded bone graft substitute.

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)

Miriam C. Provost

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

**510(k) Number** K043172

510(k) Premarket Notification: TruGraft™ BGS Syringe