Exceed® Biplanar Expandable Interbody System

{0} FDA U.S. FOOD & DRUG ADMINISTRATION May 29, 2026 Spine Wave, Inc. Ronald Smith Executive Vice President - Quality, Regulatory and Clinical Affairs Three Enterprise Dr. Suite 210 Shelton, Connecticut 06484 Re: K261159 Trade/Device Name: Exceed® Biplanar Expandable Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: April 8, 2026 Received: April 8, 2026 Dear Mr. Smith: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K261159 - Ronald Smith Page 2 (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). {2} K261159 - Ronald Smith Page 3 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 {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K261159 | ? | | Please provide the device trade name(s). | | ? | | Exceed® Biplanar Expandable Interbody System | | | | Please provide your Indications for Use below. | | ? | | The Exceed® Biplanar Expandable Interbody System with TiCell® Nano Advanced Surface Technology is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Exceed® Biplanar Expandable Interbody System is to be used with autograft bone and/or allogenic bone graft composed of cancellous, and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The Exceed® Biplanar Expandable Interbody System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} K261159 | 510(k) #: | 510(k) Summary | Prepared on: 2026-04-08 | | --- | --- | --- | | Contact Details | | 21 CFR 807.92(a)(1) | | Applicant Name | Spine Wave, Inc. | | | Applicant Address | Three Enterprise Drive Suite 210 Shelton CT 06484 United States | | | Applicant Contact Telephone | 203-712-1846 | | | Applicant Contact | Mr. Ronald Smith | | | Applicant Contact Email | rsmith@spinewave.com | | | Device Name | | 21 CFR 807.92(a)(2) | | Device Trade Name | Exceed® Biplanar Expandable Interbody System | | | Common Name | Intervertebral body fusion device | | | Classification Name | Intervertebral Fusion Device With Bone Graft, Lumbar | | | Regulation Number | 888.3080 | | | Product Code(s) | MAX | | | Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) | | Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | | K231275 | Exceed® Biplanar Expandable Interbody System | MAX | | Device Description Summary | | 21 CFR 807.92(a)(4) | | The Exceed® Biplanar Expandable Interbody System is a lumbar intervertebral body fusion device fabricated from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The implant is provided unexpanded with a nose tapered in both the lateral and vertical planes, and is expanded in situ using the Exceed® Inserter. The implant features TiCell® Nano Surface Technology, a proprietary etched surface with micro and nano-scale features on the superior and inferior surfaces for resistance to migration and to facilitate fusion. The implant is provided in different heights, lengths, and lordotic angles to accommodate the anatomical needs for a range of patients, and is designed to accommodate graft material. | | | | Intended Use/Indications for Use | | 21 CFR 807.92(a)(5) | | The Exceed® Biplanar Expandable Interbody System with TiCell® Nano Advanced Surface Technology is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Exceed® Biplanar Expandable Interbody System is to be used with autograft bone and/or allogenic bone graft composed of cancellous, and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The Exceed® Biplanar Expandable Interbody System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device. | | | | Indications for Use Comparison | | 21 CFR 807.92(a)(5) | | The Exceed® Biplanar Expandable Interbody System is substantially equivalent to the predicate. The Exceed® Biplanar Expandable Interbody System has the same intended use as the predicate. Specifically, the devices are intended to be used for intervertebral body | | | Page 1 of 2 {5} K261159 fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. Therefore, the subject Exceed® Biplanar Expandable Interbody System is substantially equivalent to its predicate in intended use, and no new issues of safety and effectiveness are raised. # Technological Comparison 21 CFR 807.92(a)(6) The Exceed® Biplanar Expandable Interbody System has technological characteristics equivalent to those of the predicate device, including design, and material composition. # Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) Mechanical performance in dynamic axial compression and dynamic compression shear (ASTM F2077) was verified for the Exceed® Biplanar Expandable Interbody System. Clinical testing is not applicable. Evaluation of the subject device performance data as compared to other legally marketed device has found that the Exceed® Biplanar Expandable Interbody System is substantially equivalent. Page 2 of 2