← Product Code [OVD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OVD) · K253401 # SCRIPT™ Implant System (K253401) _Globus Medical, Inc. · OVD · Apr 29, 2026 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OVD/K253401 ## Device Facts - **Applicant:** Globus Medical, Inc. - **Product Code:** [OVD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OVD.md) - **Decision Date:** Apr 29, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3080 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Indications for Use SCRIPT™ Lumbar Spacers, including SCRIPT ALIF™, SCRIPT XLIF™, SCRIPT XLIF EX™, SCRIPT TLIF™, SCRIPT TLIF EX™, and SCRIPT TLIF-A™, are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. SCRIPT™ Lumbar Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone or a bone void filler as cleared by the FDA for use in intervertebral body fusion to facilitate fusion. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation. SCRIPT ALIF IA™ Lumbar Spacers are integrated lumbar interbody fusion devices indicated for use at one or more levels of the lumbosacral spine (L1-S1), as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. These devices are intended to be used with or without three screws and/or anchors which accompany the implants. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). In addition, these devices are intended for stand-alone use in patients with DDD at one or two levels only when ≤20° lordotic implants are used with three screws per implant. SCRIPT™ ALIF IA Lumbar Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone or a bone void filler as cleared by the FDA for use in intervertebral body fusion to facilitate fusion. ## Device Story SCRIPT™ Implant System provides structural stability following discectomy; includes patient-matched lumbar spacers (static, integrated, expandable) designed to accommodate vertebral endplate topography. Spacers are implanted via anterior, anterolateral, lateral, posterior, or transforaminal approaches. System integrates with ExcelsiusGPS™ navigation for surgical placement. Spacers are filled with autograft/allograft bone or bone void filler to facilitate fusion. Integrated spacers (ALIF IA) may be used with screws/anchors for stand-alone fixation in specific DDD cases. Devices are used in clinical settings by surgeons; navigation components assist in precise implant positioning. Patient benefits include structural support and fusion facilitation in spinal surgery. ## Clinical Evidence No clinical data. Evidence consists of bench testing (mechanical performance per ASTM F2077/F2267) and cadaveric usability testing to validate patient-specific contouring, system integration, and navigation accuracy. ## Technological Characteristics Materials: Titanium alloy (additive manufacturing), wrought titanium alloy, PEEK polymer, cobalt chromium. Design: Patient-matched endplates, static/expandable/integrated configurations. Navigation: Compatible with ExcelsiusGPS™ system. Standards: ASTM F2077, ASTM F2267. ## Regulatory Identification An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion. ## Special Controls *Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution. ## Predicate Devices - HEDRON™ Lumbar Spacers & SABLE™ Expandable Spacer ([K222270](/device/K222270.md)) - RISE™ Spacers ([K221894](/device/K221894.md)) - Carlsmed aprevo lumbar interbody fusion devices ([K222082](/device/K222082.md), [K243635](/device/K243635.md)) - Modulus™ Interbody Systems ([K203714](/device/K203714.md)) - MOD-EX XLIF™ Interbody System ([K220478](/device/K220478.md)) ## Reference Devices - ExcelsiusGPS™ ([K191100](/device/K191100.md)) - ExcelsiusHub™ ([K211616](/device/K211616.md)) - ExcelsiusXR™ ([K241525](/device/K241525.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION April 29, 2026 Globus Medical, Inc. Jennifer Antonacci, Ph.D. Director, Regulatory Affairs 2560 General Armistead Ave. Audubon, Pennsylvania 19403 Re: K253401 Trade/Device Name: SCRIPT™ Implant System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD, MAX, PHM, OLO, SBF Dated: March 18, 2026 Received: March 19, 2026 Dear Dr. Antonacci: 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} K253401 – Dr. Jennifer Antonacci 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 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (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 ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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} K253401 – Dr. Jennifer Antonacci Page 3 Sincerely, KATHERINE D. KAVLOCK - S for 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} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. 510(k) Number (if known) K253401 Device Name SCRIPT™ Implant System Indications for Use (Describe) SCRIPT™ Lumbar Spacers, including SCRIPT ALIF™, SCRIPT XLIF™, SCRIPT XLIF EX™, SCRIPT TLIF™, SCRIPT TLIF EX™, and SCRIPT TLIF-A™, are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. SCRIPT™ Lumbar Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone or a bone void filler as cleared by the FDA for use in intervertebral body fusion to facilitate fusion. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation. SCRIPT ALIF IA™ Lumbar Spacers are integrated lumbar interbody fusion devices indicated for use at one or more levels of the lumbosacral spine (L1-S1), as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. These devices are intended to be used with or without three screws and/or anchors which accompany the implants. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). In addition, these devices are intended for stand-alone use in patients with DDD at one or two levels only when ≤20° lordotic implants are used with three screws per implant. SCRIPT™ ALIF IA Lumbar Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone or a bone void filler as cleared by the FDA for use in intervertebral body fusion to facilitate fusion. 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. 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." FORM FDA 3881 (8/23) PSE Publishing Services (301) 443-6740 {4} K253401 Page 1 of 4 510(k) Summary: SCRIPT™ Implant System Company: Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403 610-930-1800 Contact: Jennifer Antonacci, Ph.D. Director, Regulatory Affairs Secondary Contact: Katherine Warren Regulatory Specialist Date Prepared: April 28, 2026 Device Name: SCRIPT™ Implant System Common Name: Intervertebral Body Fusion Device Stereotaxic Instruments Classification: SCRIPT™ Lumbar Spacers Per 21 CFR as follows: §888.3080 Intervertebral Body Fusion Device Product Code(s): MAX, OVD, PHM Regulatory Class: II, Panel Code: 87 ExcelsiusGPS® Instruments Per 21 CFR as follows: §882.4560 Stereotaxic Instruments Product Codes OLO, SBF Regulatory Class: II, Panel Code: 87 Primary Predicate: HEDRON™ Lumbar Spacers & SABLE™ Expandable Spacer (K222270) Other Predicates: RISE™ Spacers (K221894) Carlsmed aprevo lumbar interbody fusion devices (K222082, K243635) Modulus™ Interbody Systems (K203714) MOD-EX XLIF™ Interbody System (K220478) Reference Devices: ExcelsiusGPS™ (K191100) ExcelsiusHub™ (K211616) ExcelsiusXR™ (K241525) {5} K253401 Page 2 of 4 ## Purpose: The purpose of this submission is to request clearance for the SCRIPT™ Implant System, including patient-specific lumbar interbody fusion devices (Lumbar Spacers). SCRIPT™ Lumbar Spacers may also be used with compatible ExcelsiusGPS™ instruments for use with ExcelsiusGPS™, ExcelsiusHub™, and/or ExcelsiusXR™. ## Device Description: ### SCRIPT™ Lumbar Spacers SCRIPT™ Lumbar Spacers are lumbar interbody fusion devices used to provide structural stability following discectomy. Each SCRIPT™ spacer is designed with patient-matched endplates to accommodate the topography of the patient's vertebral endplates. SCRIPT™ Spacers include static, static integrated (designated by IA), and expandable (designated by EX) designs, and are offered in different shapes and footprints to accommodate various surgical approaches to the spine, including anterior, anterolateral, lateral, posterior, or transforaminal approaches. SCRIPT™ integrated spacers are anterior lumbar interbody fusion devices used with or without screws and/or anchors. All SCRIPT™ Lumbar Spacers are manufactured from titanium alloy. The static SCRIPT™ spacers and the endplates of the expandable SCRIPT™ spacers are additively manufactured from titanium powder. The internal components of the expandable SCRIPT™ spacers are manufactured from wrought titanium alloy and radiolucent PEEK polymer, and the drive screw is manufactured from wrought cobalt chromium or titanium alloy. ### ExcelsiusGPS™ Instruments ExcelsiusGPS™ Instruments are nonsterile, reusable instruments that can be used with ExcelsiusGPS™, ExcelsiusHub™ and ExcelsiusXR™ for navigated surgical placement of interbody fusion devices. ## Indications for Use: ### SCRIPT™ Lumbar Spacers SCRIPT™ Lumbar Spacers, including SCRIPT ALIF™, SCRIPT XLIF™, SCRIPT XLIF EX™, SCRIPT TLIF™, SCRIPT TLIF EX™, and SCRIPT TLIF-A™, are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. SCRIPT™ Lumbar Spacers are to be filled {6} K253401 Page 3 of 4 with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone or a bone void filler as cleared by the FDA for use in intervertebral body fusion to facilitate fusion. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation. SCRIPT ALIF IA™ Spacers are integrated lumbar interbody fusion devices indicated for use at one or more levels of the lumbosacral spine (L1-S1), as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. These devices are intended to be used with or without three screws and/or anchors which accompany the implants. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). In addition, these devices are intended for stand-alone use in patients with DDD at one or two levels only when ≤20° lordotic implants are used with three screws per implant. SCRIPT™ ALIF IA Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone or a bone void filler as cleared by the FDA for use in intervertebral body fusion to facilitate fusion. ## Performance Testing: Mechanical testing (axial compression, compression shear, subsidence, and expulsion) was conducted in accordance with the "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007, ASTM F2077, and ASTM F2267 to demonstrate substantial equivalence to the predicate devices. Verification and validation testing were conducted to confirm that the SCRIPT™ implants meet performance requirements. The following testing was conducted: - Cadaveric Usability testing under clinically relevant scenarios. This testing demonstrated that: - SCRIPT™ Lumbar Spacers as planned and manufactured met the requirements of contouring to the endplates, and were designed per the plan - Non-clinical system, software, and instrument verification and validation - demonstrated compliance with user needs and corresponding design inputs - Instrument integration testing verified system accuracy was maintained for navigating SCRIPT™ Lumbar Spacers with ExcelsiusGPS™ Instruments {7} K253401 Page 4 of 4 ## Technological Characteristics: Subject implants have the same or similar technological characteristics as the predicate devices including design, intended use, material composition, function, and range of sizes. ## Basis of Substantial Equivalence: Subject devices have 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 devices to the predicate devices. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OVD/K253401](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OVD/K253401) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com