← Product Code [MAX](/productcode/MAX) · K260837 # VersaLift Expandable System (K260837) _Life Spine, Inc. · MAX · May 12, 2026 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K260837 ## Device Facts - **Applicant:** Life Spine, Inc. - **Product Code:** [MAX](/productcode/MAX.md) - **Decision Date:** May 12, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3080 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Indications for Use When used as an interbody fusion device, the VersaLift® Expandable System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine. ## Device Story Expandable interbody fusion device; provides structural support for spinal fusion. Implanted in lumbosacral spine (L2-S1) by surgeons; requires supplemental internal fixation (e.g., pedicle screws). Device expands (6mm to 16mm) to match patient anatomy; teeth on superior/inferior surfaces prevent migration/rotation. Packed with autograft or allogeneic bone graft to promote fusion. Single-use; sterile. Benefits patient by restoring disc height and facilitating fusion in DDD cases. ## Clinical Evidence Bench testing only. Static compression shear, static axial compression, dynamic compression shear, and dynamic axial compression testing performed per ASTM F2077. ## Technological Characteristics Expandable interbody spacer; materials: titanium alloy (Ti-6Al-4V ELI, ASTM F136) and Cobalt Chrome (CO-26Cr-6MO, ASTM F1537). Features teeth for vertebral interface. Sterile, single-use. Mechanical performance tested per ASTM F2077. ## 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 - Life Spine TruLift Micro Expandable Cage System ([K232611](/device/K232611.md)) - Life Spine ProLift Micro Expandable Cage System ([K223430](/device/K223430.md), [K212520](/device/K212520.md)) - Globus Rise Spacer System ([K113447](/device/K113447.md)) - Globus Sable Spacer System ([K192115](/device/K192115.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 May 12, 2026 Life Spine, Inc. Angela Batker Director of RA/QA & Corporate Compliance Officer 13951 Quality Dr. Huntley, Illinois 60142 Re: K260837 Trade/Device Name: VersaLift Expandable System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: March 13, 2026 Received: March 13, 2026 Dear Angela Batker: 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} K260837 - Angela Batker 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} K260837 - Angela Batker 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} Page 1 of 1 | 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. | K260837 | ? | | Please provide the device trade name(s). | | ? | | VersaLift Expandable System | | | | Please provide your Indications for Use below. | | ? | | When used as an interbody fusion device, the VersaLift® Expandable System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine. | | | | 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) | ? | | Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? | {4} K260837- Page 1 of 2 510(k) Summary VersaLift Expandable System Submitted By: Life Spine, Inc. 13951 S. Quality Drive Huntley, IL 60142 Telephone: 847-884-6117 Fax: 847-884-6118 510(k) Contact: Angela Batker Life Spine, Inc. 13951 S. Quality Drive Huntley, IL 60142 Telephone: 847-884-6117 Fax: 847-884-6118 Date Prepared: March 12th, 2026 Trade Name: VersaLift Expandable System Common Name: Intervertebral Body Fusion Device Classification: MAX, CFR 888.3080, Class II Primary Predicate: Life Spine TruLift Micro Expandable Cage System (K232611) Additional Predicate: Life Spine ProLift Micro Expandable Cage System (K223430, K212520) Globus Rise Spacer System (K113447) Globus Sable Spacer System (K192115) Device Description: The VersaLift® Expandable System is available in a range of sizes and footprints and can expand to the desired height (6mm to 16mm) to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) and Cobalt Chrome (CO-26Cr-6MO) as described by ASTM F136 and ASTM F1537. The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration. All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the VersaLift® Expandable System components with components from any other system or manufacturer. The VersaLift® Expandable System components should never be reused under any circumstances. {5} K260837- Page 2 of 2 ## Intended Use of the Device: When used as an interbody fusion device, the VersaLift® Expandable System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine. ## Technological Characteristics: The VersaLift Expandable Spacer System is substantially equivalent to the predicate systems in terms of design, materials, and indications for use and sizing. ## Material: This submission seeks clearance of a device made from titanium alloy (Ti-6Al-4V ELI) and Cobalt Chrome (CO-26Cr-6MO) as described by ASTM F136 and ASTM F1537. This is the same material used in the predicate devices. ## Performance Data: The VersaLift Expandable System was tested through Static compression shear, Static Axial Compression, Dynamic Compression Shear and Dynamic Axial Compression according to ASTM F2077 to demonstrate substantial equivalence to the Life Spine TruLift Micro Expandable Spacer System K232611. ## Substantial Equivalence: The VersaLift Expandable System was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and mechanical performance. ## Conclusion: The information presented demonstrates the substantial equivalency of VersaLift Expandable System. --- **Source:** [https://fda.innolitics.com/device/K260837](https://fda.innolitics.com/device/K260837) **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. 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