CONCORDE Bullet Lumbar Interbody System

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 20, 2015 Medos International, Sàrl % Ms. Jaclyn Porsolt Regulatory Affairs Specialist DePuy Spine, a Johnson & Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767 Re: K151773 Trade/Device Name: CONCORDE® Bullet Lumbar Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MQP Dated: October 21, 2015 Received: October 22, 2015 Dear Ms. Porsolt: 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {1}------------------------------------------------ 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/ResourcesforYou/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 yours, # Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. K151773 Page 1 of 1 510(k) Number (if known) K151773 ### Device Name CONCORDE® Bullet Lumbar Interbody System ## Indications for Use (Describe) The CONCORDE Bullet System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the CONCORDE Bullet System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a PLIF or TLIF approach using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device these implants are intended for use with DePuy Spine supplemental internal fixation products. The CONCORDE Bullet System is indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. This system is also indicated for treating fractures of the thoracic and lumbar spine. This system is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. When used as a vertebral body pplacement device this system is intended for use with DePuy Spine supplemental internal fixation products. | Type of Use (Select one or both, as applicable) | |------------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"><span style="font-size:20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | | <div style="display:flex; align-items:center;"><span style="font-size:20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." {3}------------------------------------------------ ## 510(k) SUMMARY | A. | Submitter Information | | |----|--------------------------------|------------------------------------------------------------------------------------| | | Manufacturer: | Medos International Sárl | | | | Chemin-Blanc 38 | | | | 2400 Le Locle, Switzerland | | | Submitter: | DePuy Spine, Inc. | | | | 325 Paramount Drive | | | | Raynham, MA 02767 | | | Contact Person: | Jaclyn Porsolt | | | Address: | 325 Paramount Drive | | | | Raynham, MA 02767 | | | Telephone number: | (508) 828-3269 | | | Fax number: | (508) 828-3797 | | | Email: | jporsol1@its.jnj.com | | B. | Date Prepared | November 13, 2015 | | C. | Device Name | | | | Trade/Proprietary Name: | CONCORDE® Bullet Lumbar Interbody System | | | Common/Usual Name: | Intervertebral Body Fusion Device; Spinal<br>Intervertebral Body Fixation Orthosis | | | Classification and Regulation: | Class II per 21 CFR 888.3080 | | | Classification Product and | | | | Panel Code: | MAX; Orthopedic | | | Subsequent Regulation: | 21 CFR 888.3060 | | | Subsequent Classification | | | | Product and Panel Code: | MQP; Orthopedic | | | | | #### D. Predicate Device Name The subject device is substantially equivalent to the primary predicate device, CONCORDE Bullet Lumbar Interbody System (K140759), and additional predicate devices, Medtronic CAPSTONE® Spinal System (K123027) and Stryker Spine AVS® PL and AVS® UniLIF PEEK Spacers (K143163). {4}------------------------------------------------ #### E. Device Description The CONCORDE Bullet Lumbar Interbody System consists of polymer/carbon fiber composite cages. The cages are available in varying shape and size configurations to match patient anatomy. The polymer/carbon fiber cage structure is radiolucent with tantalum x-ray markers so that healing can be assessed by normal radiographic methods. The cages have teeth that resist rotation and migration and have cavities to accept the packing of bone graft. The cages are offered in both sterile forms. The CONCORDE Bullet System is implanted using Class I manual surgical instruments that are considered exempt from premarket notification. The purpose of this 510(k) submission is to modify the indications for use to include treatment of spinal deformities as an adjunct to fusion and the use of allogenic bone graft comprised of cancellous and/or corticocancellous bone graft as an alternative to autogenous bone graft. #### F. Indications for Use The CONCORDE Bullet System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the CONCORDE Bullet System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a PLIF or TLIF approach using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device these implants are intended for use with DePuy Spine supplemental internal fixation products. The CONCORDE Bullet System is indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. This system is also indicated for treating fractures of the thoracic and lumbar spine. This system is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. When used as a vertebral body replacement device this system is intended for use with DePuy Spine supplemental internal fixation products. ### G. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use {5}------------------------------------------------ The technological characteristics of the subject CONCORDE Bullet Lumbar Interbody System remain unchanged from their currently marketed predicate versions in their design, material, performance, and intended use. #### H. Materials The materials of the subject devices remain unchanged from the currently marketed predicate devices. The devices are manufactured from Carbon Fiber Reinforced PEEK-OPTIMA LT1 Compound (CFRP). The tantalum x-ray markers conform to ASTM F-560. #### I. Performance Data A literature analysis of published clinical data is provided to support the modified Indications for Use. The clinical and radiographic outcomes demonstrate that lumbar interbody fusion devices similar to the CONCORDE Bullet Lumbar Interbody System are as safe and effective as the predicate devices for the modified Indications for Use. No additional testing was required as there were no changes to the technological characteristics of the CONCORDE Bullet Lumbar Interbody System. #### J. Conclusion Based on the technological characteristics, comparison to predicate devices and clinical performance data, the subject CONCORDE Bullet Lumbar Interbody System is as safe and as effective as the predicate devices due to similar intended use and technological characteristics.