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?

Lumbar spinal stenosis back pain

FFX® is a minimally invasive fusion solution for stenosis patients

FFX® + Decompression

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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