InFill Interbody Fusion Devices

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, resembling a bird-like shape. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Pinnacle Spine Group, LLC % Ms. Rebecca K. Pine Consultant 1601 Elm Street, Suite 300 Dallas, Texas 75201 Re: K150206 Trade/Device Name: InFill® Interbody Fusion Devices Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 10, 2015 Received: March 12, 2015 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 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set April 3, 2015 {1}------------------------------------------------ Page 2 - Ms. Rebecca K. Pine 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely vours. Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ | DEPARTMENT OF HEALTH AND HUMAN SERVICES | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | Food and Drug Administration | | | Indications for Use | | | 510(k) Number (if known) | Form Approved: OMB No. 0910-0120 | | K150206 | Expiration Date: January 31, 2017<br>See PRA Statement below. | | Device Name | | | InFill® Interbody Fusion Devices | | | Indications for Use (Describe) | | | InFill® interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients.<br>InFill® interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® interbody<br>fusion device is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the<br>treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of<br>discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to<br>be used in patients who have had at least six months of non-operative treatment. InFill® interbody fusion device is<br>intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar<br>spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches<br>include anterior, lateral and transforaminal. | | | Type of Use (Select one or both, as applicable) | | | <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | | PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | FOR FDA USE ONLY | | | Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | | This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | FORM FDA 3881 (1/14) | Page 1 of 1 | | PSC Publishing Services (301)-443-6740 | EP | |----------------------|-------------|--|----------------------------------------|----| |----------------------|-------------|--|----------------------------------------|----| {3}------------------------------------------------ #### 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: | March 9, 2015 | | CONTACT PERSON: | Rebecca K Pine<br>1601 Elm Street, Suite 300<br>Dallas, TX 75201<br>Phone: 760.809.5178<br>Fax: 760.290.3216 | | TRADE NAME: | InFill® Interbody Fusion Devices | | COMMON NAME: | Spinal Implant | | CLASSIFICATION<br>NAME: | Intervertebral Body Fusion Device | | DEVICE<br>CLASSIFICATION: | Class 2, per 21 CFR 888.3080 | | PRODUCT CODE | MAX | PREDICATE DEVICES: (primary) InFill® Interbody Fusion Device (K133721) # Substantially Equivalent To: The modified InFill® Interbody Fusion Device is substantially equivalent in intended use, principal of operation and technological characteristics to the InFill® Interbody Fusion Device cleared under premarket notification K133721. # Description of the Device Subject to Premarket Notification: The InFill® interbody fusion device is a radiolucent implantable device manufactured from PEEK and tantalum (marker material). The implant is available in various sizes to suit the individual pathology and anatomical conditions of the patient. The InFill® interbody fusion device is provided sterile, for single use only. # Indication for Use: InFill® is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill® is designed for use with autogenous bone graft to facilitate fusion. InFill® is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative {4}------------------------------------------------ treatment. InFill® is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and transforaminal. # Technical Characteristics: The modified InFill® intervertebral body fusion device has similar physical and technical characteristics to the predicate device. An additional length (26mm) has been added to the product family. | Technical<br>Characteristics | InFill® interbody<br>fusion devices,<br>(41-TLIF convex,<br>42-TLIF lordotic<br>oblique; 43-TLIF<br>Contour) | InFill® interbody<br>fusion device (41-<br>TLIF convex, 42-<br>TLIF lordotic<br>oblique; 43-TLIF<br>Contour)<br>(K133721) | |-------------------------------|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------| | Shape | Box-shaped, bullet<br>nose<br>Banana-shaped,<br>bullet nosed | SAME | | Bone to implant<br>surface | Surface teeth | SAME | | Bone graft<br>support feature | Central<br>fenestration | SAME | | Primary implant<br>material | PEEK OPTIMA<br>LT1 ® | SAME | | Surgical<br>Approach | Transforaminal | SAME | | Lengths | 42-TLIF<br>26mm<br>28mm<br>30mm<br><br>43-TLIF<br>26mm<br>28mm<br>30mm<br>32mm<br>34mm | 42-TLIF<br>30mm<br><br>43-TLIF<br>28mm<br>30mm<br>32mm<br>34mm | | Heights | 41-TLIF<br>8-16mm<br><br>42-TLIF<br>8-16mm | 41-TLIF<br>8-12mm<br>14mm<br>16mm<br><br>42-TLIF<br>8-10mm<br>12mm<br>14mm<br>16mm | {5}------------------------------------------------ #### Performance Data: An FEA (Finite Element Analysis) was performed to assess the introduction of the new InFill device sizes into the existing product family. The worst case construct was identified and characterized. The results of the analysis demonstrated that no new mechanical testing is required. The analysis demonstrated the substantial equivalence of the new device sizes to the predicate device. The modified InFill® intervertebral body fusion device met all specified criteria and did not raise new safety or performance questions. #### Basis for Determination of Substantial Equivalence: The Indication/Intended Use and the fundamental scientific technology of the modified device have not been changed and are the same as those described in the unmodified predicate device. The modified InFill® interbody fusion device is found to have a safety and effectiveness profile that is similar to the predicate device and is determined by Pinnacle Spine Group LLC, to be substantially equivalent to the InFill® interbody fusion device (K133721).