INFILL GRAFT DELIVERY SYSTEM

K121476 · Pinnacle Spine Group, LLC · FMF · Aug 29, 2012 · General Hospital

Device Facts

• Record ID: K121476
• Device Name: INFILL GRAFT DELIVERY SYSTEM
• Applicant: Pinnacle Spine Group, LLC
• Product Code: FMF · General Hospital
• Decision Date: Aug 29, 2012
• Decision: SESE
• Submission Type: Special
• 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 disposable piston syringe and cannula applicator used for delivering bone graft materials (allograft, autograft, or synthetic) to orthopedic surgical sites. Used by surgeons in clinical settings; device facilitates controlled placement of graft material. System includes accessories for mixing graft materials. Device is provided sterile for single use. Output is the physical delivery of graft material to the surgical site, aiding in bone fusion procedures.

Clinical Evidence

Bench testing only. Testing included simulated use, volume verification, separation force, liquid leak, and biocompatibility testing. No clinical data provided.

Technological Characteristics

Disposable piston syringe and cannula applicator. Materials and configuration are identical to the predicate device. Sterile, single-use. No electronic components or software.

Indications for Use

Indicated for delivery of hydrated allograft, autograft, or synthetic bone graft material to orthopedic surgical sites.

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

• InFill™ Graft Delivery System (K111632)

Submission Summary (Full Text)

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#### 6. 510(k) Summary

Section 6

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 | | AUG 2 9 2012 |
|---------------------------|--------------------------------------------------------------------------------------------------------------|--|--------------|
| DATE PREPARED: | May 16, 2012 | | |
| CONTACT PERSON: | Rebecca K Pine<br>1601 Elm Street, Suite 300<br>Dallas, TX 75201<br>Phone: [phone]<br>Fax: [phone] | | |
| TRADE NAME: | InFill™ Graft Delivery System | | |
| COMMON NAME: | Piston Syringe | | |
| CLASSIFICATION<br>NAME: | Intervertebral Body Fusion Device | | |
| DEVICE<br>CLASSIFICATION: | Class 2, per 21 CFR 880.5860 | | |
| PRODUCT CODE | FMF | | |
| PREDICATE DEVICES: | InFill™ graft Delivery System (K111632) | | |

### Substantially Equivalent To:

The modified InFill™ Graft Delivery System is substantially equivalent in intended use, The mounted in in - Graft Delivery of Characteristics to the InFill™ Graft Delivery System cleared under premarket notification K111632.

# Description of the Device Subject to Premarket Notification:

Description of the Device Subject to System is comprised of a disposable medical piston The mounted ini in - Gran Donvery of accessories for mixing bone graft materials and symge, a cannufacci applicator up and two costs on the costs 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.

## Technical Characteristics:

The modified InFill™ Graft Delivery System has the same technological characteristics The modified in overall design, materials and configuration compared to the current InFill™ Graft Delivery System.

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### Section 6

### Performance Data:

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Performance Data.
All necessary testing has been performed for the InFill™ the device nextsmass All necessary testing has been performed for the and demonstrate the device performs as substantial equivalence to the predicate conce as a caree entative of finished devices.

476

The device design was qualified through the following tests:

K121

- Simulated Use Testing .
- Volume Verification .
- Separation Force Testing .
- Liquid Leak Testing .
- Biocompatibility Testing .

The modified InFill™ Graft Delivery System met all specified criteria and did not raise new safety or performance questions.

# Basis for Determination of Substantial Equivalence:

Basis for Determination of Substantial Bqurnatific technology of the modified The Indication Intendod Obe and are the same as those described in the unmodified device nave not been changed and and the the the time of EillTM G A Belivery System predicale device. The mounted in in - Graft Delivery System (K111632).

Pinnacle Spine Group Modified InFill™ Graft Delivery System

Page 11 of 40 Premarket Notification

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

#### Public Health Service

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

AUG 29 2012

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

Re: K121476

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: August 2, 2012 Received: August 3, 2012

Dear Ms. Rebecca K. 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Ms. Pine

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/ReportaProblem/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 yours,

for

Mark N. Melkerson

Mark N. Melkerson 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

K121476 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 The mirin-" Gran Dorvery byean betic bone graft material to an orthopedic surgical site.

AND/OR

Prescription Use (Part 21 CFR 801 Subpart D) 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)

Neil H. Ogle for men

ivision Sign-Off) . vision of Surgical, Orthopedic, nd Restorative Devices

(k) Number K121476

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