NITRO Interbody Fusion Cage System Family

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it. April 25, 2023 CTL Medical Corporation Barry E. Sands President and Founder ROMIS Inc. 110 Haverhill Road Suite 524 Amesbury, Massachusetts 01913 Re: K220513 Trade/Device Name: NITRO Interbody Fusion Cage System Family Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, MAX, OVE Dated: April 12, 2023 Received: April 12, 2023 Dear Mr. Sands: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {1}------------------------------------------------ ce determination does not mean that FDA Page 2 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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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Sincerely. # Brent Showalter -S Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K220513 Device Name NITRO Interbody Fusion Cage System Family ### Indications for Use (Describe) "CERVICAL" NITRO Interbody Fusion Cage System Family (i.e., the MATISSE NITRO Anterior Cervical Interbody Fusion Cage System and the MONET NITRO Anterior Cervical Interbody Fusion Cage System) are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radios. Cervical NITRO Interbody Fusion Cage System Family are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach from the C2-C3 disc space using autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Cervical NITRO Interbody Fusion Cage System Family are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. When the MONET Anterior Cervical Interbody Fusion Cage System is used with the Supplementary Fixation Plate assembly, the plate-spacer assembly is a stand-alone device intended for use at one disc level or two contiguous levels of the cervical spine (from the C2-C3 disc space to C7-T1 disc space). "LUMBAR" NITRO Interbody Fusion Cage System Family (i.e.; the MONDRIAN NITRO Lumbar Interbody Fusion Cage System consisting of ALIF/OLIF, DLIF, PLIF, and TLIF) are indicated for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Lumbar NTRO Interbody Fusion Cage System Family are intended to be used with supplemental spinal fixation systems. Patients should be skeletally mature and have six months of non-operative therapy prior to treatment with an intervertebral cage. Lumbar NTRO Interbody Fusion Cage System Family with hyperlordotic cage offerings (>20°) require the use of anterior fixation. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ 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." {4}------------------------------------------------ # 510(k) SUMMARY # CTL Medical's NITRO Interbody Fusion Cage System Family (Cervical and Lumbar) #### l. SUBMITTER'S ADDRESS, TELEPHONE NUMBER, CONTACT PERSON CTL Medical Corporation Sean Suh 4550 Excel Parkway, Suite 300 Addison, TX 75001 Phone: (214) 545-5820 Email: ssuh@ctlamedica.com ### Contact Person: Barry E. Sands RQMIS Inc. 110 Haverhill Road, Suite 524 Amesbury, MA 01913 Phone: (978) 358-7307 Email: barrysands@rqmis.com Facsimile: (978) 477-0206 Date Prepared: April 11, 2023 #### II. SUBJECT DEVICE Trade/proprietary name of device: Common or Usual Name: Classification Name: Regulation Number: Classification: Product Code(s) # NITRO Interbody Fusion Cage System Family (Cervical and Lumbar) Intervertebral Body Fusion Device Intervertebral Body Fusion Device with Bone Graft, Cervical and Lumbar 21 C.F.R. §888.3080 Class II ODP, MAX, OVE {5}------------------------------------------------ #### III. PREDICATE DEVICES ## Primary Predicate: - . VALEO Spacer System; VALEO II Interbody Fusion Device System (K143518), (K161405) (primary predicate) # Additional Predicates: - MATISSE Anterior Cervical Interbody Cage System (K121569, K162682, K172212) - 0 MONET Anterior Cervical Interbody Fusion Cage System (K172788) - . MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate (K182151), and - o MONDRIAN Lumbar Interbody Fusion Cage System (K192863) ### IV. DEVICE DESCRIPTION The NITRO Interbody Fusion Cage System Family (Cervical and Lumbar ) cages offer a complete line of interbody cages for the cervical levels C2-C7 and the lumbar levels L2-S1 to be used with supplemental fixation and bone graft material. The cages are made of silicon nitride material and are available in a variety of widths, lengths, and lordotic angles, (parallel angles to accommodate varying degrees of lordosis and varying patient anatomy). The NITRO Interbody Fusion Cage System Family consists of hollow intervertebral spacers with an axial void designed to hold bone graft material. The bone graft is packed into and around the cage to further facilitate fusion. Each system includes a complete set of instruments to implant the devices properly. The NITRO Interbody Fusion Cage System Family consists of following systems: - MATISSE NITRO Anterior Cervical Interbody Fusion Cage (ACIF) System. - MONET NITRO Anterior Cervical Interbody Fusion Cage (ACIF) System with Supplemental fixation. - MONDRIAN NITRO Lumbar Interbody Fusion Cage System: - о MONDRIAN NITRO ALIF/OLIF Cage System - MONDRIAN NITRO DLIF Cage System о - O MONDRIAN NITRO PLIF Cage System - о MONDRIAN NITRO TLIF Cage System The NITRO Interbody Fusion Cage System Family includes implants and instruments. The subject system uses the same instruments and fundamental technology as do their functional counterparts in CTL Medical's already cleared MATISSE, MONET, and MONDRIAN surgical instruments. As with the predicates, the subject device is {6}------------------------------------------------ implanted using a combination of device-specific and universal instruments manufactured from stainless steel materials that conform to ASTM F899. # Intended Use/Indications for Use: CERVICAL "CERVICAL" NITRO Interbody Fusion Cage System Family (i.e., the MATISSE NITRO Anterior Cervical Interbody Fusion Cage System and the MONET NITRO Anterior Cervical Interbody Fusion Cage System) are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Cervical NITRO Interbody Fusion Cage System Family are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach from the C2-C3 disc space to C7-T1 disc space using autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Cervical NITRO Interbody Fusion Cage System Family are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. When the MONET Anterior Cervical Interbody Fusion Cage System is used with the Supplementary Fixation Plate assembly, the plate-spacer assembly is a stand-alone device intended for use at one disc level or two contiguous levels of the cervical spine (from the C2-C3 disc space to C7-T1 disc space). # Intended Use/Indications for Use: LUMBAR "LUMBAR" NITRO Interbody Fusion Cage System Family (i.e.; the MONDRIAN NITRO Lumbar Interbody Fusion Cage System consisting of ALIF/OLIF, DLIF, PLIF, and TLIF) are indicated for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Lumbar NITRO Interbody Fusion Cage System Family are intended to be used with supplemental spinal fixation systems. Patients should be skeletally mature and have six months of non-operative therapy prior to treatment with an intervertebral cage. {7}------------------------------------------------ Lumbar NITRO Interbody Fusion Cage System Family with hyperlordotic cage offerings (>20°) require the use of anterior fixation. ### v. TECHNOLOGICAL CHARACTERISTICS The NITRO Interbody Fusion Cage System Family is substantially equivalent to the following predicate devices: Primary predicate VALEO Spacer System; VALEO II Interbody Fusion Device System (K143518) and additional predicates MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate (K182151), and MONDRIAN Lumbar Interbody Fusion Cage System (K192863). The NITRO Interbody Fusion Cage System Family has identical intended use and indications, technological characteristics, and principles of operation as the primary and secondary predicates. Additionally, the company also used the additional predicate devices (MATISSE, MONDRIAN, and VALEO II devices above) to demonstrate that some technological characteristics of the subject device do not raise different questions of safety and effectiveness. ### VI. PERFORMANCE DATA The performance testing of the worst-case subject device MONET NITRO Cervical Cage was compared to the performance testing of the worst-case reference predicate cages (Cervical and Lumbar). Testing included Axial Static Compression, Shear Static Compression, Static Torsion, Axial Dynamic Compression, Subsidence, and Expulsion. Additionally, the Company also conducted Plate Pull-Off, Screw Push Out, and Pyrogenicity testing. ### VII. CONCLUSION The NITRO Interbody Fusion Cage System Family (Cervical and Lumbar) has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. Thus, the subject device is substantially equivalent to the predicate device. The technological differences between the subject device and the predicate do not raise new questions of safety and effectiveness. Any minor differences in technological characteristics have been tested and documented.