FFX®

Back pain. Instability.
Complementary fixation.

Think Facets.

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10,000 +
implantations

CE
& FDA

4
publications

1
Randomized
Controlled Trial

2024-27

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

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?

FFX® is a minimally invasive fusion solution for stenosis patients

FFX® + Decompression

FFX decompression
FFX decompression : text

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

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 to Pedicle Screw Fixation in Patients with Lumbar Spinal Stenosis: A Long-Term Study. medRxiv [Preprint]. 2023.

+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®

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.

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.

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.

Less reoperations at 2 years postop ["]Evaluation of the Efficacy and Safety of FFX Facet Cages Compared to Pedicle Screw Fixation in Patients with Lumbar Spinal Stenosis: A Long-Term Study. medRxiv [Preprint]. 2023.

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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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