FFX®

Back pain. Instability.
Complementary fixation.

Think Facets.

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14,000 +
implantations

CE
& FDA

8
publications

1
Randomized
Controlled Trial

2024-27

FDA Breakthrough Device Designation for FFX®
Spine technology award, Orthopedics This Week
Innovation and Safety awards, Medical Device Network Excellence Awards (2025)
Official selection, Prix Galien France (2025)
Bpifrance Health Industries and Technologies Accelerator
Member of La French Care

Why
FFX® ?

Facet
Syndrome

Lumbar Spinal
Stenosis

Comple­mentary
Fixation

Why FFX® ?

Facet
Syndrome

About 15-45% of the time the facet joint is a cause of chronic low back pain [“]Perolat R, Kastler A, Nicot B, Pellat JM, Tahon F, Attye A, Heck O, Boubagra K, Grand S, Krainik A. Facet joint syndrome: from diagnosis to interventional management. Insights Imaging. 2018 Oct;9(5):773-789. doi: 10.1007/s13244-018-0638-x. Epub 2018 Aug 8. PMID: 30090998; PMCID: PMC6206372. Manchikanti L, Manchikanti KN, Cash KA, Singh V, Giordano J. Age-related prevalence of facet-joint involvement in chronic neck and low back pain. Pain Physician. 2008 Jan;11(1):67-75. PMID: 18196171.

FFX® offers a sustainable pain treatment

with a minimally invasive fusion solution

FFX® facet cage for minimally invasive lumbar facet arthrodesis
FFX® facet cage for minimally invasive lumbar facet arthrodesis

Lumbar
Spinal Stenosis

Half of the patients only experience substantial
back pain improvement
after decompression alone according to analysis of 25,349 patients [“]Knight J, Rangnekar R, Richardson D, McIlroy S, Bell D, Ahmed AI. Does low-back pain improve after decompressive spinal surgery? A prospective observational study from the British Spine Registry. J Neurosurg Spine. 2023 Jul 14;39(4):583-592. doi: 10.3171/2023.5.SPINE23116. PMID: 37486861.

What causes
back pain?

Lumbar spinal stenosis: narrowing of the spinal canal compressing the nerves

FFX® is a minimally invasive fusion solution for stenosis patients

FFX® + Decompression

FFX® facet cages placed in the facet joints after lumbar decompression
Decompression alone; facet joint pain and/or spondylolisthesis (≤ grade I) and/or anticipated iatrogenic instability; pedicle screws + decompression
FFX® facet cages placed in the facet joints after lumbar decompression
The FFX® zone, by severity: decompression alone; FFX® + decompression for facet joint pain and/or spondylolisthesis (≤ grade I) and/or anticipated iatrogenic instability; pedicle screws + decompression

with facet pain, low-grade spondy.
or anticipated postop. instability

Facet joint syndrome: degenerated lumbar facet joints as a source of low back pain
Facet joint syndrome: degenerated lumbar facet joints as a source of low back pain
Facet joint syndrome: degenerated lumbar facet joints as a source of low back pain

Complementary
Fixation

Increase fusion opportunities and stability
with FFX® used as a complementary fixation solution.

Clinical
Data ["]Facet arthrodesis with the FFX device: One-year results from a prospective multicenter study. Int J Spine Surg. 2020.

Evaluation of the Efficacy and Safety of FFX Facet Cages Compared With Pedicle Screw Fixation in Patients With Lumbar Spinal Stenosis: A Long-Term Study. Clin Spine Surg. 2024.

+3.7 mm

Average postop.
foraminal height

91 %

2-year postop.
bony fusion

93 %

Patients improved
after 12 months

See more data

Favorable Data

Compared to Pedicle Screws, for Lumbar Spinal Stenosis

Pedicle Screws

FFX®

Operative time: 99.4 min with FFX® vs 152.5 min with pedicle screws, 35% shorter (Srour, Cureus, 2022)

Reduction of operating time (minutes) ["]Comparison of operative time and blood loss with the FFX® device versus pedicle screw fixation during surgery for lumbar spinal stenosis: A retrospective cohort study. Cureus. 2022.

Blood loss: 251 mL with FFX® vs 446.5 mL with pedicle screws, 44% less (Srour, Cureus, 2022)

Reduction of bleeding (mL) ["]Comparison of operative time and blood loss with the FFX® device versus pedicle screw fixation during surgery for lumbar spinal stenosis: A retrospective cohort study. Cureus. 2022.

Misplacement rate: 3.9% asymptomatic with FFX® (Srour et al., Int J Spine Surg, 2020) vs 12.7% without navigation and 7.9% with navigation for pedicle screws (meta-analysis, Spine, 2007)

Low misplacement rate ["]Pedicle screw placement accuracy: a meta-analysis: A meta-analysis. Spine (Phila Pa 1976). 2007.

Facet arthrodesis with the FFX device: One-year results from a prospective multicenter study. Int J Spine Surg. 2020.

Reoperation at 2 years: 3.6% with FFX® vs 10.7% with pedicle screws (Houari et al., Clin Spine Surg, 2024)

Less reoperations at 2 years postop ["]Evaluation of the Efficacy and Safety of FFX Facet Cages Compared With Pedicle Screw Fixation in Patients With Lumbar Spinal Stenosis: A Long-Term Study. Clin Spine Surg. 2024.

Preoperative imaging of a patient with lumbar spinal stenosis before FFX® surgery

Preop.

Imaging 2 years after decompression and FFX® facet fusion

2-year Postop.

FFX® can be implanted through all surgical approaches

FFX® can be implanted through open, minimally invasive and percutaneous approaches
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As with all medical devices, there are risks and considerations to device use. Please refer to the device labeling for a full discussion of potential risks, contraindications, warnings, precautions, and instructions for use.

The information presented on this website is intended only as a brief summary for visitor convenience. Not all products or indications are cleared in every country and may be subject to further local variations. For specific product information, you should always consult the local product documentation. For advice on medical issues, you should always consult your local medical practitioner.

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