GoLIF! Lumbar Interbody Fusion System

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

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! Lumbar Interbody Fusion System is designed to facilitate surgical planning for lumbar interbody fusion procedures. It provides a comprehensive set of instruments and implants to support various surgical approaches and patient anatomies.
Pre-Operative Assessment
The system supports pre-operative assessment by offering a range of implant sizes and configurations, allowing surgeons to select the most appropriate components based on patient-specific anatomical considerations and surgical goals.
Operating Room Workflow Integration
The GoLIF! system is designed for efficient integration into the operating room workflow, with instruments and implants organized for ease of use and quick access during procedures.
Physician Tip

Familiarize yourself with the full range of implant sizes and instrumentation available within the GoLIF! system to optimize patient-specific surgical planning. Proper pre-operative templating and assessment of patient anatomy are crucial for successful outcomes with this system.

The GoLIF! Lumbar Interbody Fusion System is a standalone implant and instrumentation system. It does not inherently integrate with external AI tools for surgical planning, guidance, or robotic systems. Its integration is primarily within the manual surgical workflow.

Details

Category Surgical AI
Pricing Unknown
Compliance
BAA AvailableUnknown
HIPAA CompliantUnknown
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Neurosurgery, Orthopedics

What the Web Says

The GoLIF! Lumbar Interbody Fusion System is a medical device designed for spinal fusion procedures (PLIF & TLIF) in the lumbar spine. It features sterile implants and instruments, aiming to enhance surgical efficiency and reduce risks like infection through its "Good to Go!" sterile packaging and no-touch loading mechanism. The system has received CE Mark certification for use in Europe and FDA 510(k) clearance in the US.

Overall: Positive

Strengths

  • 100% sterile and new instruments and implants for every surgery, reducing infection and cross-contamination risks.
  • Streamlined and repeatable surgical technique designed to improve surgical efficiency.
  • No need for instrument cleaning, sterilization, or inspection, saving time and resources for healthcare facilities.
  • Fully traceable implants with a no-touch loading mechanism to maintain sterility.
  • Lower carbon footprint compared to traditional systems due to reduced transportation, sterilization, and cleaning requirements.
  • Implants are made from radiolucent PEEK polymer with a large open architecture for bone graft and a unique dome shape allowing for lordosis.

Limitations

No significant limitations found in public reviews. Consider checking vendor documentation or requesting a demo for a thorough evaluation.

Based on reviews from: thespinemarketgroup.com, fda.gov, getsetsurgical.com, recordowl.com, innolitics.com, nih.gov, xcmedico.com

Last updated: 2026-10-30

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Press & Coverage

medicaldesignandoutsourcing.com
Demetra Holding acquires majority stake in Swiss-based GetSet Surgical, expanding strategic portfolio in the Spine sector
Demetra Holding acquired a 51% stake in GetSet Surgical, a move aimed at enhancing Demetra's infection management solutions and orthopedic offerings. The acquisition will facilitate the introduction of GetSet's GoLIF! Lumbar Interbody Fusion system to the U.S. market, pending FDA 510(k) clearance, while the system is already CE-marked and available internationally.
2025-02
startupticker.ch
Demetra Holding acquires majority stake in GetSet Surgical
Demetra Holding has acquired a 51% stake in GetSet Surgical, a Swiss-based provider of sterile-packed spine surgical solutions. This acquisition is set to expand the availability of GetSet Surgical's products, including the GoLIF! Lumbar Interbody Fusion system, in global markets, with a focus on US market entry pending FDA 510(k) clearance.
2025-02
medicaldevice-network.com
Demetra Holding acquires majority stake in GetSet Surgical
Demetra Holding has acquired a 51% stake in GetSet Surgical, aiming to expand its presence in the spine sector and integrate GetSet's sterile spine procedure kits. The GoLIF! Lumbar Interbody Fusion system is expected to be introduced in the US later this year, pending 510(k) clearance, and is already available in European and other international markets.
2025-02
fda.gov
GoLIF! Lumbar Interbody Fusion System 510(k) Summary
The FDA has released a 510(k) summary for the GoLIF! Lumbar Interbody Fusion System, indicating its intended use for intervertebral body fusion in the lumbosacral spine. The system includes sterile implantable cages and instruments designed to restore biomechanical integrity and is indicated for patients with symptomatic Degenerative Disc Disease.
2025-03
medtechspectrum.com
510(k) Clearances for March 2025
GetSet Surgical SA received 510(k) clearance for its GoLIF! Lumbar Interbody Fusion System on March 21, 2025, categorized under Orthopedic devices. This regulatory approval allows the system to be marketed in the United States.
2025-03
recordowl.com
GetSet Surgical GoLIF! Lumbar Interbody Fusion System
The GetSet Surgical GoLIF! Lumbar Interbody Fusion System is classified as a Class C medical device. This listing provides regulatory information and classification details for the product.
2024-07

Videos

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

View all on YouTube

Frequently Asked Questions

The GoLIF! system itself is a lumbar interbody fusion system with sterile implants and instruments designed for PLIF and TLIF procedures, focusing on surgical efficiency and reducing risks. While the GoLIF! system does not inherently feature AI, surgical AI is being developed to enhance precision in surgical planning for procedures like TLIF, by predicting optimal cage height and lumbar lordosis correction. This suggests that AI could potentially be used in conjunction with systems like GoLIF! for pre-operative planning, though GoLIF! itself does not contain AI.
The GoLIF! Lumbar Interbody Fusion System has received certification for use in Europe (CE Mark) and has been cleared for use by the US FDA 510(k). It is indicated 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, from L1-L2 to L5-S1, including those with up to Grade 1 Spondylolisthesis or retrolisthesis.
Alternatives to lumbar interbody fusion (LIF) systems like GoLIF! include other fusion techniques such as Anterior Lumbar Interbody Fusion (ALIF), Lateral Lumbar Interbody Fusion (LLIF or XLIF), and Posterior Lumbar Interbody Fusion (PLIF) or Transforaminal Lumbar Interbody Fusion (TLIF) using different devices. Non-surgical alternatives like physical therapy, medication, injections, and artificial disc replacement (ADR) are also considered. Expandable interbody cages, which are a growing segment in lumbar fusion, offer advantages like restored foraminal height, controlled distraction, and improved segmental alignment.
Specific pricing for the GoLIF! system is not publicly available. However, the cost of lumbar spinal fusion surgery can vary significantly, with average cash prices ranging from approximately $37,538 to $53,366 across different states in the US, not including anesthesia, imaging, or other doctor fees. Some studies indicate that minimally invasive surgery (MIS) can be substantially more favorable in cost at one year compared to open surgery, though costs may equalize over two years.
The GoLIF! system is designed for PLIF and TLIF procedures, which involve potential complications inherent to spinal fusion surgery. Lumbar fusion is a major surgery with months of recovery and permanent loss of motion at the fused level. While the GoLIF! system aims to reduce risks through sterile, new instrumentation, general complications of lumbar fusion can include infection, blood loss, and prolonged recovery times. Expandable cages, while beneficial, do not primarily explain superior fusion rates compared to static cages.

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