FBC 921 (ALIF)

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FBC Device ApS Finn Christensen, M.D., Ph.D. CEO Viengevej 100 Risskov, 8240 Dk Re: K180695 Trade/Device Name: FBC 921™ (ALIF) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: June 7, 2018 Received: June 8, 2018 Dear Dr. Christensen: 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. 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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 forth in the quality systems (QS) regulation (21 CFR Part 820); July 12, 2018 {1}------------------------------------------------ ### Page 2 - Dr. Finn Christensen K180692 and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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There is a faint, light blue watermark in the background, partially obscuring the text. For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K180695 Device Name FBC 921™ (ALIF) #### Indications for Use (Describe) The FBC 921™ is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spiral surgery at the involved spinal level(s) and may have up to Grade 1 spondylolisthesis at the involved level(s). This device is intended to be used with posterior supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------| | <span style="text-decoration: underline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: underline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The rest of the letters in "device" are in black, and there is a registered trademark symbol next to the word. # 510(k) SUMMARY | Submitted by | FBC Device Aps<br>Viengevej 100<br>DK-8240 Risskov<br>DENMARK | |-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contacts | Pr. Finn Bjarke Christensen MD, PhD (CEO) Phone +45 2344 2012 e-mail<br>finn@fbcdevice.com ; Dr Bruce ROBIE PhD (COO) Phone +1.201.757.1581, +45 4078<br>3167(when in Europe) e-mail bruce@fbcdevice.com Regulatory contact : Dr Isabelle<br>DRUBAIX PhD (Idée Consulting) idrubaix@nordnet.fr | | Date Prepared | July 11, 2018 | | Common Name | Intervertebral body fusion device | | Trade Name | FBC 921™ (ALIF) | | Classification Name | Intervertebral Fusion Device with Integrated Fixation, Lumbar | | Class | II | | Product Code | OVD | | CFR section | 888.3080 | | Device panel | ORTHOPEDIC | | Legally marketed<br>predicate devices | Primary predicate: Lanx Fusion System manufactured by Lanx, LLC (K102738)<br>Additional predicates: Lanx Fusion System manufactured by Lanx, LLC (K123767); Infix<br>Anterior Lumbar System manufactured by Zimmer Spine, INC (K132790); 4WEB Spinal<br>Implant Products manufactured by 4WEB, INC (K112316, K142112); Alif Interfixated<br>System manufactured by Nuvasive, INC (K151214); Synfix Evolution Secured Spacer<br>System manufactured by Synthes (USA) (K150673)<br>Reference Device: Pyramid Anterior Plate Fixation System manufactured by Medtronic<br>Sofamor Danek, INC (K013665) | | Indications for use | The FBC 921™ is intended for spinal fusion procedures to be used with autogenous bone<br>graft in skeletally mature patients with degenerative disc disease ("DDD ") at one or two<br>contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with<br>degeneration of the disc confirmed by history and radiographic studies. These patients<br>should have had six months of non-operative treatment. These DDD patients may have<br>had a previous non-fusion spinal surgery at the involved spinal level(s) and may have up<br>to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is<br>intended to be used with posterior supplemental spinal fixation systems that have been<br>cleared for use in the lumbosacral spine. | | Description of the device | The FBC 921™ is a two-part ALIF device consisting of top and bottom components with an integral anterior plate to allow additional fixation. Both the bottom and the top components come in three footprints. The top component comes in three footprints and one size. It has a starting lordosis of 9 degrees. Lordosis for each assembly is adjustable between 9 and 21 degrees. The bottom component includes the height variation. It comes in the three footprints and four heights (8, 10, 12, and 14mm). The device is anchored to the superior and inferior vertebra using three Ø5.5 variable angle screws. The top and bottom components are made of titanium alloy (Ti-6Al-4V) additively manufactured from biocompatible titanium alloy (Ti-6Al-4V) using powder per ASTM F3001 which are then machined to their final geometry. Screws are made from an implant grade titanium alloy (Ti6Al4V ELI) meeting the requirements of ASTM F136. The FBC 921™ is a single-use device delivered sterile (gamma sterilization) and supplied with surgical instruments (reusable - provided non-sterile). | | Technological<br>characteristics compared<br>to the predicate devices | As was established in this submission, the FBC 921™ is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. FBC 921™ was shown to be substantially equivalent and have the same or similar technological characteristics to its predicate devices through comparison in areas including intended use, indications for use, function, material composition and manufacturing process, design, range of sizes and mechanical performance. | | Non-clinical performance<br>data | Nonclinical testing was performed to demonstrate that the FBC 921™ is substantially equivalent to other predicate devices.<br>The characterization of the chemical composition, mechanical and metallographic properties was performed in accordance with ASTM F2924-14 and ASTM E8/E8M. Mechanical testing in compliance with: FDA's "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" was performed for the FBC 921™. The following mechanical tests were performed: Static and dynamic axial compression (per ASTM F2077), Static and dynamic shear compression (per ASTM F2077), Static torsion (per ASTM F2077), subsidence (per ASTM F2267) and expulsion (per internal protocol). The characteristics of any particulate wear debris (per ASTM F1877) generated during the mechanical test were carried out using SEM/EDS (scanning electron microscopy/energy dispersive spectrometry) techniques. Microscopic analysis was conducted of parts following dynamic testing to assess contact at all three intended areas of contact: (1) on the front of the column with the locking screw, (2) on the back of the column with the top, and (3) posteriorly. A pressure film study was conducted to evaluate contact between the top and bottom components at different lordotic angles. Lastly, assessment of the potential for locking screw loosening was conducted. In addition, dynamic testing in torsion (axial rotation) was performed to +/- 4Nm for 1 million cycles.<br>The result of these studies shows that the FBC 921™ meets or exceeds the performance of the predicate devices and does not introduce any new risks. Therefore, the FBC 921™ is substantially equivalent to the predicate devices. Bacterial endotoxin testing per USP 39 NF 34 (2016) for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device. | | Conclusion | Based on the design features, technological characteristics, feature comparisons, indications for use, and non-clinical performance testing, the FBC 921™ has demonstrated substantial equivalence to the identified predicate devices. | {4}------------------------------------------------