SAGICO OSI Spinal System by Osimplant

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. May 21, 2018 Spinal Analytics & Geometrical Implant Co, LLC James J. Gibson Jr., CPA, Ph.D. SAGICO Project Manager 2189 West Busch Boulevard Tampa, Florida 33612 Re: K180220 Trade/Device Name: SAGICO OSI SPINAL SYSTEM by Osimplant Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP, KWO Dated: February 8, 2018 Received: February 9, 2018 Dear Dr. Gibson: 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 forth in the quality systems (QS) regulation (21 CFR Part 820); {1}------------------------------------------------ K180220 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). 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. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Ronald P. Jean -S 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) K180220 #### Device Name SAGICO OSI SPINAL SYSTEM by Osimplant #### Indications for Use (Describe) The SAGICO OSI SPINAL SYSTEM by Osimplant is intended for use in the non-cervical spine. When used for anterior/anterolateral and posterior, non-cervical pedicle fixation system, the SAGICO OSI SPINAL SYSTEM by Osimplant is intended to provide additional support during fusion using autograft or allograft in Skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: - · Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); - · Spondylolisthesis; - · Trauma (i.e. fracture or dislocation); - · Spinal stenosis; - · Curvatures (i.e. scoliosis, kyphosis, and/or lordosis); - · Tumor: - · Pseudoarthrosis; and - Failed previous fusion When used for posterior non-cervical pedicle screw fixation in pediatric patients, the SAGICO OSI SPINAL SYSTEM by Osimplant implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The SAGICO OSI SPINAL SYSTEM by Osimplant for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. Type of Use (Select one or both, as applicable) | <span style="font-family: sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | |----------------------------------------------------------------------------------------------| | <span style="font-family: sans-serif;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | # 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the text 'K180220 - Page 1 of 2'. This text appears to be a document identifier and page number. The document identifier is K180220, and the page number is 1 of 2, indicating that this is the first page of a two-page document. Image /page/3/Picture/1 description: The image shows a logo for SAGICO, which stands for Sinai Analytics & Geometrical Implant Co. The logo features a blue hexagon shape with the word "SAGICO" in bold, sans-serif font inside. Below the hexagon, the full name of the company is written in a smaller, less bold font. The logo appears to be for a company that specializes in analytics and geometrical implants. SAGICO OSI SPINAL SYSTEM by Osimplant Traditional 510(k) Premarket Notification ## 510(k) Summary Device Trade Name(s): SAGICO OSI SPINAL SYSTEM by Osimplant Classification Panel: Orthopedic Common Name: Pedicle Screw Spinal System Class and Reference: Class II Product Code(s): NKB, KWQ, KWP Thoracolumbosacral Pedicle Screw System (NKB) Classification Name(s): Class II per 21 CFR §888.3070 Appliance, Fixation, Spinal Intervertebral Body (KWQ) Class II per 21 CFR §888.3060 Appliance, Fixation, Spinal Interlaminal (KWP) Class II per 21 CFR §888.3050 Applicant/Official Contact Person: James J. Gibson, Jr., CPA, PhD SAGICO Project Manager Email: JG@Sagico.com Tel. (813) 830-3636 / Fax (813) 433-5586 Submitter /Manufacturer: Spinal Analytics & Geometrical Implant Co, LLC dba/ SAGICO 2189 West Busch Blvd Tampa, Florida 33612 Tel. (813) 830-3636 / Fax (813) 433-5586 Preparation Date: May 18th, 2018 ## Predicate Devices The subject device is substantially equivalent to the primary predicate device XIA® 3 Spinal System - Stryker Spine (K113666) and additional predicate devices, USS Small Stature System - Synthes Spine Medtronic Spine (K071373), CD HORIZON - Spinal System - Sofamor Danek USA (K091445), TSRH Spinal System - Sofamor Danek USA (K994121), XIA 3 Spinal System - Stryker Spine (K111492) ## Purpose: The purpose of this submission is to request clearance for new system "SAGICO OSI SPINAL SYSTEM by Osimplant". ## Device Description: The SAGICO OSI SPINAL SYSTEM by Osimplant constructs of monoaxial screws, uniplanar screws, polyaxial screws, reduction screws, locking cap set screws, rods, hooks, monoaxial and muttiaxial transverse connectors and associated surgical instruments. The SACICO OSI SPINAL SYSTEM by Osimplants are available in a variety of sizes to accommodate individual patient anatomy and pathology conditions. SAGICO OSI SPINAL SYSTEM by Osimplant implants are designed to adapt 5.5mm diameter rods; the implants are manufactured from Ti6A14V alloy and offered in a sterile package option. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows a logo for SAGICO, which stands for SP NGI Analytics & Geometrical Implant Co. The logo is a blue hexagon with the word "SAGICO" in white letters inside. Below the hexagon, the full name of the company is written in smaller letters. The logo is simple and professional, and it conveys a sense of precision and expertise. SAGICO OSI SPINAL SYSTEM by Osimplant Traditional 510(k) Premarket Notification # Indications for use: The SAGICO OSI SPINAL SYSTEM by Osimplant is intended for use in the non-cervical spine. When used for anterior/anterolateral and posterior, non-cervical pedicle fixation system, the SAGICO OSI SPINAL SYSTEM by Osimplant is intended to provide additional support during fusion using autograft or allograft in Skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: - Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc > confirmed by history and radiographic studies); - Spondylolisthesis: - Trauma (i.e. fracture or dislocation); - MMMMM Spinal stenosis; - Curvatures (i.e. scoliosis, kyphosis, and/or lordosis); - Tumor; - Pseudoarthrosis; and - Failed previous fusion When used for posterior non-cervical pedicle screw fixation in pediatric patients, the SAGICO OSI SPINAL SYSTEM by Osimplant implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The SAGICO OSI SPINAL SYSTEM by Osimplant for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. # Technological Characteristics: Testing performed on SAGICO OSI SPINAL SYSTEM by Osimplant included in this submission demonstrates that the SAGICO OSI SPINAL SYSTEM by Osimplant is substantially equivalent to predicate devices cleared by FDA for commercial distribution in the United States market. The SAGICO OSI SPINAL SYSTEM by Osimplant substantial equivalence determination to the predicate systems is based on comparable data drawn from design, labeling, and indications for use, function and implant materials. # Performance data: Non-clinical performance data testing conducted to support substantial equivalence for the SAGICO OSI SPINAL SYSTEM by Osimplant device included: # ASTM F1717-04 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model - Static Compression Bending Test - Dynamic Compression Bending Test # ASTM F1798-13 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants - Σ Axial Gripping Test - Σ Axial Torsion Gripping Test - Flexion Extension Static Test # Basis of Substantial Equivalence: The SAGICO OSI SPINAL SYSTEM by Osimplant has been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject and predicate devices. # Conclusion: The SAGICO OSI SPINAL SYSTEM by Osimplant has been shown to be substantially equivalent to legally marketed predicate devices with respect to its indications for use, design, function, and materials.