Orthopedic · 510(k) · 2025
GoLIF! Lumbar Interbody Fusion System
GetSet Surgical, SA. Cleared by FDA on 21 March 2025 under submission K250186, product code MAX (intervertebral fusion device with bone graft, lumbar). What FDA's record says, in FDA's words.
Device record · K250186
- Device. GoLIF! Lumbar Interbody Fusion SystemDEVICE
- Company. GetSet Surgical, SA (CH)COMPANY
- Decision. 21 March 2025, 510(k), substantially equivalent (traditional review); received 22 January 2025DECISION
- Panel. OrthopedicPANEL
- Product code. MAX, Intervertebral Fusion Device With Bone Graft, LumbarCODE
- Regulation. 21 CFR 888.3080, Class IIREG
- Source. FDA database entry · decision document (7 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The GetSet GoLIF! Lumbar Interbody Fusion (IBF) system is indicated for interbody fusion with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft in patients with symptomatic Degenerative Disc Disease (DDD) at either one or two contiguous levels in the lumbar spine, from L1-L2 to L5-S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. 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 six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via a transforaminal approach. These devices are intended to be used with supplemental posterior fixation, which has been cleared by the FDA for use in the lumbar spine.
The product code's definition, from FDA's classification record. Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedradiographs (X-ray)
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 9,297 reports filed against devices carrying product code MAX. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Malfunction · Catalyft¿ PL Expandable Interbody System · MDT Puerto Rico Operations Co, Med Rel · report 2647346-2026-00559
Information was received from healthcare provider (HCP) via a manufacturer representative regarding a Patient having Spinal therapy. It was reported that the bone fusion was observed six months after surgery, but cage jacking down of a few MM was observed. There were no patient symptoms reported. There were no further complications reported regarding the event. Additional information was received that there was no in-patient hospitalization/prolongation of existing hospitalization necessary or […]
30 September 2026 · Malfunction · CAPSTONE PTC¿ Spinal System · MSD Deggendorf Mfg · report 3011795235-2026-00067
30 September 2026 · Malfunction · CAPSTONE PTC · MSD Deggendorf Mfg · report 3011795235-2026-00068
29 September 2026 · Malfunction · Catalyft¿ PL Expandable Interbody System · MDT Puerto Rico Operations Co, Med Rel · report 2647346-2026-00557
Information was received from healthcare provider (HCP) via a manufacturer representative regarding a Patient implanted with Cage ha ving Posterior lumbar interbody fusion (PLIF) therapy for Lumbar spinal canal stenosis. It was reported that bone fusion was observed 6 months after surgery, but several mm of cage jackdown was observed. There was no patient symptom reported. There were no further complications reported regarding the event.
29 September 2026 · Malfunction · CAPSTONE Spinal System · MEDTRONIC PUERTO RICO OPERATIONS CO., HU · report 2647346-2026-00558
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code MAX, in Orthopedic, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
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