INFILL GRAFT DELIVERY SYSTEM

K111632 · Pinnacle Spine Group, LLC · FMF · Aug 11, 2011 · General Hospital

Device Facts

• Record ID: K111632
• Device Name: INFILL GRAFT DELIVERY SYSTEM
• Applicant: Pinnacle Spine Group, LLC
• Product Code: FMF · General Hospital
• Decision Date: Aug 11, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The InFill™ Graft Delivery System is intended to be used for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site.

Device Story

InFill™ Graft Delivery System is a manual, single-use, sterile device designed for orthopedic surgery. It consists of a standard piston syringe (barrel with female luer and plunger) and a cannulated applicator tip. The device is operated by a surgeon or surgical staff to deliver hydrated bone graft materials (allograft, autograft, or synthetic) directly to a surgical site. By providing a controlled delivery mechanism, it assists in the precise placement of graft material, facilitating bone healing or reconstruction. The device is purely mechanical and does not involve electronic or automated components.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manual piston syringe consisting of a barrel with female luer and a plunger, paired with a cannulated applicator tip. Single-use, sterile, disposable device. No energy source, software, or electronic components.

Indications for Use

Indicated for use in orthopedic surgical procedures requiring the delivery of hydrated allograft, autograft, or synthetic bone graft material.

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

• Wright Medical Bone Graft Syringe (K023088)
• FibriJet Graft Delivery System (K100754)

Submission Summary (Full Text)

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510(k) Summary

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#### 6. 510(k) Summary

This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| APPLICANT: | Pinnacle Spine Group, LLC |
|---------------------------|--------------------------------------------------------------------------------------------------------------|
| DATE PREPARED: | June 09, 2011 |
| CONTACT PERSON: | Rebecca K Pine<br>1601 Elm Street, Suite 300<br>Dallas, TX 75201<br>Phone: [phone]<br>Fax: [phone] |
| TRADE NAME: | InFillTM Graft Delivery System |
| CLASSIFICATION<br>NAME: | Piston Syringe |
| DEVICE<br>CLASSIFICATION: | Class II |
| REGULATION<br>NUMBER | 880.5860 |
| PRODUCT CODE | FMF |
| | PREDICATE DEVICES: Wright Medical Bone Graft Syringe, K023088<br>FibirJet Graft Delivery System K100754 |

## Substantially Equivalent To:

The InFill™ Graft Delivery System is substantially equivalent in intended use, principal of operation and technological characteristics to the Wright Medical Bone Graft Delivery System and the FibriJet Graft Delivery System.

# Description of the Device Subject to Premarket Notification:

The InFill™ Graft Delivery System is comprised of a commercially available disposable medical piston syringe (syringe barrel w/female luer, plunger) and a cannulated applicator tip. The InFill™ Graft Delivery System is provided sterile, for single use only.

## Indication for Use:

The InFill™ Graft Delivery System is intended to be used for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site.

### Technological Characteristics:

The InFill™ Graft Delivery System has the same technological characteristics and is

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similar in overall design, materials and configuration compared to the predicates.

#### Basis for Determination of Substantial Equivalence:

Upon reviewing and comparing intended use, design, materials, principle of operation and overall technological characteristics, the InFill™ Graft Delivery System is determined by Pinnacle Spine Group, LLC, to be substantially equivalent to existing legally marketed devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Pinnacle Spine Group, LLC % Ms. Rebecca K. Pine 1601 Elm Street, Suite 300 Dallas, Texas 75201

Re: K111632

Trade/Device Name: InFill™ Graft Delivery System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF Dated: June 09, 2011 Received: June 13, 2011

AUG 1 1 2011

Dear Ms. Pine:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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

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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/Reportal?roblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Mark N. Mel

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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5. Indications for Use Statement

# INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: InFill™ Graft Delivery System

Indications for Use:

The InFill™ Graft Delivery System is intended to be used for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site.

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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Thilke Rabe for mkm
(Division Sign Off)

(Division Sign-O Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111632