GoLIF! Lumbar Interbody Fusion System

by GetSet Surgical  · Based in Switzerland → — Pioneering in spine surgery with sterile-packaged implants and instruments.
Neurosurgery Orthopedics
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Regulatory Status Disclosed

Overview

The GoLIF! Lumbar Interbody Fusion System by GetSet Surgical is a sterile-packaged, single-use spinal implant and instrumentation system designed for posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) procedures. The system is engineered to support orthopedic and spine surgeons performing lumbar fusions in hospital operating rooms and ambulatory surgery centers.

By providing pre-sterilized, single-use implants and disposable instruments, the system integrates into the surgical workflow by eliminating the need for pre-operative and post-operative instrument processing, sterilization, and inventory tracking. This ready-to-use delivery model helps streamline operating room turnaround times and reduces the logistical burdens associated with traditional reusable instrument trays.

Notable capabilities of the GoLIF! system include:

  • Radiolucent PEEK Cages: Features a large open architecture designed for bone graft material placement.
  • Anatomical Design: Implants feature a tapered, self-distracting tip to facilitate insertion, a dome shape to accommodate natural anatomy, and superior/inferior teeth to resist migration.
  • Comprehensive Sterile Kit: Includes dedicated single-use instruments for height measurement, endplate decortication, and cage length determination.
  • Traceability: Packaged with detachable labels to simplify patient record documentation and inventory management.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Sterile-packaged implants and instruments
  • Indicated for PLIF & TLIF procedures
  • Streamlined and repeatable surgical technique
  • PEEK cages with large open architecture for bone graft
  • Unique dome shape allowing 7-18 degrees lordosis
  • Tapered tip for distraction upon insertion
  • Teeth on superior and inferior surfaces to resist migration and expulsion
  • Designed for minimally invasive approaches

Use Cases

  • Interbody fusion with autograft and/or allogeneic bone graft in patients with symptomatic Degenerative Disc Disease (DDD) at one or two contiguous levels in the lumbar spine (L1-L2 to L5-S1)
  • Treatment of DDD patients who may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels
  • Used with supplemental posterior fixation

What Physicians Need to Know

Surgical Planning Capabilities
The GoLIF! system offers a range of implant sizes (8-14mm in 1mm increments) and a unique dome shape that allows for 7-18 degrees of lordosis, crucial for restoring disc height and optimizing spinal alignment during surgical planning. Its radiolucent PEEK material is also advantageous for post-operative imaging.
Intraoperative Guidance
GoLIF! instruments are designed for a streamlined and repeatable surgical technique, featuring a cut-off corner on the cage to facilitate guidance and rotation during insertion.
3D Reconstruction Quality
The GoLIF! cages are made from radiolucent PEEK polymer, which minimizes imaging artifacts, allowing for clearer visualization of bone growth and fusion in post-operative 3D reconstructions.
Robotic Surgery Integration
While GoLIF! is an implant system, the lumbar interbody fusion procedures for which it is indicated can be performed with robotic assistance, leveraging the precision of such platforms for implant placement.
Surgical Navigation Accuracy
The GoLIF! implants feature a self-distracting tip and serrated connection to resist migration, contributing to stable placement. When utilized with surgical navigation systems, the accuracy of GoLIF! cage placement can be precisely monitored and achieved.
Pre-Operative Assessment
The system's diverse implant heights and lordotic options directly support pre-operative assessment, enabling surgeons to select the optimal implant based on patient-specific anatomical needs and desired spinal correction.
Post-Operative Monitoring
The radiolucent PEEK material of the GoLIF! cages facilitates effective post-operative imaging, allowing for clear monitoring of fusion progress and implant stability without significant artifact interference.
Complication Prediction
The 'Good to Go!' sterile implants and instruments of the GoLIF! system are designed to reduce risks associated with infection and cross-contamination by providing 100% new and sterile instrumentation for every surgery.
Operating Room Workflow Integration
The GoLIF! system is designed for a streamlined and repeatable surgical technique with easy-to-use, chronologically ordered instrumentation. Its sterile, single-use nature eliminates the need for pre- or post-operative instrument checking, counting, cleaning, or sterilization, enhancing OR efficiency and reducing staff training.
Physician Tip

Leverage the GoLIF! system's sterile, single-use implants and instruments to minimize infection risks and streamline OR setup. The variety of cage sizes and lordotic options allows for precise anatomical restoration and sagittal balance, which should be carefully considered during pre-operative planning. The radiolucent PEEK material is excellent for post-operative imaging, ensuring clear visualization of fusion progress.

While the GoLIF! Lumbar Interbody Fusion System itself is an implant and instrument kit, its design features are highly compatible with modern AI-driven surgical planning software, intraoperative navigation systems, and robotic platforms. These external technologies can enhance the precision of implant selection and placement, optimizing patient-specific outcomes for GoLIF! procedures.

Details

Category Surgical AI
Pricing Unknown
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The GoLIF! Lumbar Interbody Fusion System received FDA 510(k) clearance (K250186) on March 21, 2025, for interbody fusion with autograft and/or allogeneic bone graft in patients with symptomatic Degenerative Disc Disease (DDD) at one or two contiguous levels in the lumbar spine.
Integrations
EHR Not specified
Specialties Neurosurgery, Orthopedics

What the Web Says

The GoLIF! Lumbar Interbody Fusion System is a sterile implant and instrument system designed for PLIF and TLIF procedures, aiming to improve surgical efficiency and reduce infection risks. It features radiolucent PEEK cages with a large graft window and a self-distracting tip. The system is designed to provide high-quality clinical outcomes with new instrumentation for every surgery.

Overall: Positive

Strengths

  • Streamlined and repeatable surgical technique for efficiency.
  • Reduced risks and complications associated with infection and cross-contamination due to sterile implants and instruments.
  • High-quality clinical outcomes with brand new instrumentation for every surgery.
  • Radiolucent PEEK cages with a large graft window for bone graft material.
  • Designed for minimally invasive approaches, potentially leading to faster recovery, less tissue retraction, decreased blood loss and pain, and reduced hospital stays.
  • Lower carbon footprint compared to traditional systems due to fewer transportation requirements, smaller/lighter sets, and no repeated sterilization or cleaning.

Limitations

  • Lumbar interbody fusion in general can have a difficult learning curve and longer operation time for some minimally invasive techniques.
  • Fixed size of traditional static cages can present intraoperative challenges, requiring exact preoperative planning and potentially aggressive impaction.
  • Risk of endplate damage, subsidence, or suboptimal alignment with static cages.
  • Potential for nerve root retraction and injury with some interbody fusion approaches.
  • Limited long-term outcome data for some newer endoscopic lumbar interbody fusion techniques.
  • Some patients report continued lower back pain or discomfort even after successful fusion, sometimes attributed to arthritis in adjacent segments.

Based on reviews from: GetSet Surgical - SPINEMarketGroup, GoLIF! Lumbar Interbody Fusion System - HealthAidb u2014 Software, Product-GoPLF-1 - GetSet Surgical, accessdata.fda.gov, Optimizing Outcomes with Expandable Interbody Fusion Devices in Lumbar Procedures, Lumbar Interbody Fusion Surgery Patient Testimonial - Orlando Orthopaedic Center, The Endoscopic Lumbar Interbody Fusion: A Narrative Review, and Future Perspective, Minimally Invasive Transforaminal Lumbar Interbody Fusion With the Space-D Access System, Miami Ortho Spine digital web platform, Top Expandable Cages of 2025: Which Lumbar Implants Are Really Leading the Way?!, Full-Endoscopic versus Minimally Invasive Lumbar Interbody Fusion for Lumbar Degenerative Diseases : A Systematic Review and Meta-Analysis - PMC, What are people's experiences with spinal fusion surgery? - Mayo Clinic Connect, Review and analysis of modern lumbar spinal fusion techniques [review] - HealthPartners, Full-Endoscopic versus Minimally Invasive Lumbar Interbody Fusion for Lumbar Degenerative Diseases : A Systematic Review and Meta-Analysis - PubMed, 9 spine surgeons discuss their favorite MIS technology, The Endoscopic Lumbar Interbody Fusion: A Narrative Review, and Future Perspective, Clinical Outcome of Full Endoscopic Trans Kambin's Triangle Lumbar Interbody Fusion: A Systematic Review - PubMed, Lateral Lumbar Interbody Fusionu2014Outcomes and Complications - PMC - NIH, A Review of Fully Endoscopic Lumbar Interbody Fusion - Journal of Minimally Invasive Spine Surgery and Technique, XLIF Surgery (Extreme Lateral Interbody Fusion) Gavin Helf's Story - MedStar Health, TLIF Lumbar Fusion L5-S1 One Day Post-Op Testimonial - YouTube, PLIF who here has had posterior only fusion and how was outcome?? - Reddit, Comparing expandable and static interbody cages in lumbar interbody fusion - PMC - NIH, Patient Testimonials | Florida Spine Associates, Minimally Invasive Lumbar Fusion Surgery Patient Testimonial (Xlif) - YouTube, Happy or regretful after TLIF surgery? : r/spinalfusion - Reddit, Two weeks post fusion (XLIF L3-L4) - overall very positive : r/scoliosis - Reddit, Xlif spinal fusion L3-L4 : r/spinalfusion - Reddit, XLIF Posterior Spinal Fusion w Laminectomy at L4-L5 Experience : r/spinalfusion - Reddit

Last updated: 2026-07-19

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Press & Coverage

accessdata.fda.gov
K250186 - 510(k) Premarket Notification - FDA
The FDA issued a 510(k) Premarket Notification for the GoLIF! Lumbar Interbody Fusion System on March 21, 2025, detailing its indications for use in patients with symptomatic Degenerative Disc Disease (DDD) at one or two contiguous levels in the lumbar spine. This document addresses previous information requests and outlines the device's classification and predicate devices.
2025-03
GetSet Surgical
GetSet Surgical - Physician Ai Tools
This page on GetSet Surgical's website mentions the GoLIF! Lumbar Interbody Fusion System and includes links to news, demos, and interviews about the company and its products. It also highlights press and coverage from ODT Magazine.
2026-04
FDA
K250186 - 510(k) Premarket Notification - FDA
This FDA listing provides details on the K250186 510(k) Premarket Notification for the GoLIF! Lumbar Interbody Fusion System, including applicant and contact information, regulation number, and product code. It serves as a regulatory announcement for the device.
2026-06
Startupticker.ch
Italian Healthcare Holding Acquires Majority Stake in GetSet Surgical - Startupticker.ch
Demetra Holding acquired a 51% stake in GetSet Surgical, with the introduction of the GoLIF! Lumbar Interbody Fusion system anticipated later in 2025 following FDA 510(k) clearance. Both GoPLF! and GoLIF! systems are already CE-marked and available in European and other international markets.
2025-02
Medical Device Network
Demetra acquires 51% stake in GetSet Surgical - Medical Device Network
Demetra Holding acquired a 51% stake in GetSet Surgical to expand its offerings in the spine sector, with the GoLIF! Lumbar Interbody Fusion system expected to launch later in the year after 510(k) clearance. The acquisition aims to integrate Demetra's technologies with GetSet's sterile spine procedure kits.
2025-02
FDA
TPLC - Total Product Life Cycle - FDA
This FDA page, updated in July 2026, lists the GoLIF! Lumbar Interbody Fusion System (K250186) as an intervertebral body fusion device intended to stabilize spinal segments. It appears in a list of substantially equivalent devices from various manufacturers.
2026-07
FDA
Establishment Registration & Device Listing - FDA
The GoLIF! Lumbar Interbody Fusion System is listed on the FDA's Establishment Registration & Device Listing page as an intervertebral fusion device with bone graft, lumbar. This indicates its official registration with the FDA.
2026-06
marketscreener.com
Demetra Holding Spa Acquires Majority Stake in Swiss-based ...
Demetra Holding Spa announced its acquisition of a majority stake in GetSet Surgical, with the GoLIF! Lumbar Interbody Fusion system expected to be introduced later in the year. This press release highlights the strategic collaboration to enhance healthcare solutions.
2025-02

Videos

Product demos, reviews, and walkthroughs for GoLIF! Lumbar Interbody Fusion System.

View all on YouTube

Frequently Asked Questions

AI algorithms can analyze extensive patient data, including imaging and medical history, to create detailed 3D images of the spine and personalize surgical plans for GoLIF! procedures. This can optimize implant sizing and placement, potentially improving surgical precision and patient-specific care by identifying ideal candidates and predicting outcomes.
AI can automate the monitoring of real-world evidence and adverse event reporting, helping manufacturers and healthcare providers maintain compliance with regulations such as FDA's Quality System Regulation and ISO 13485. It can also analyze large datasets to identify potential safety signals or performance trends for devices like GoLIF!, reducing manual workload and speeding up data analysis.
Yes, AI can process complex patient data to compare the efficacy and suitability of various fusion systems, including GoLIF!, against alternatives. This allows physicians to make more data-driven decisions tailored to individual patient needs and anatomical considerations, potentially identifying the most suitable implant or approach.
AI can analyze vast amounts of claims data and clinical outcomes to provide insights into the long-term cost-effectiveness of GoLIF! procedures, potentially saving up to $360 billion annually in US healthcare expenditure. This information can inform negotiations with payers and optimize reimbursement strategies by demonstrating value-based care and streamlining revenue cycle management.
Current AI models may face limitations due to data biases, the complexity of biological variability, and the need for extensive, high-quality long-term outcome data. While powerful, AI still requires expert clinical interpretation and validation, especially for predicting highly individualized surgical success and ensuring ethical deployment.
Integrating AI with patient data for surgical planning necessitates robust data encryption, anonymization, and strict adherence to regulations like HIPAA and GDPR. Ensuring secure data handling is paramount to protect sensitive patient information and maintain trust in AI-driven healthcare solutions, especially given the regulatory challenges in AI implementation.
AI tools are designed to augment, not replace, physician expertise, integrating as decision support systems or planning aids in preoperative, intraoperative, and postoperative phases. Training would focus on interpreting AI-generated insights, understanding model limitations, and effectively incorporating these tools into pre-operative planning and intra-operative guidance to enhance surgical precision and patient outcomes.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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