OUR EVIDENCE

Evidence empowers.

When you’re choosing a bone graft for patients, how does evidence support that decision? 

Of the 350+ spinal bone grafts available, only 2 meet robust Class III FDA evidence requirements—one of which is from Cerapedics.1,2

Not all spinal bone graft products have the same level of evidence1

For spinal grafts, the rigor of evidence required differs by US FDA regulatory pathway.1 Understanding how these evaluations vary is critical for making confident, informed decisions that impact patient outcomes.

Class III Drug/Device Combinations (PMA Devices)1

P-15 Peptide and rhBMP-2 products

These products undergo the most rigorous testing: human clinical trials. This gold standard of evidence demonstrates safety and efficacy in real-world surgical applications.

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Class II Devices (510(k)
Devices)

Formulated DBM, synthetic grafts

These products must show comparable performance to existing options through animal studies.

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Human cell or tissue/products (361 HCT/Ps)

Cellular based allografts (stem cells); DBMs without carriers; allografts (structural and non-structural)

These widely used products are not required by the FDA to undergo animal or human safety and efficacy studies.

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Why human clinical trials matter

Level 1, premarket approval (PMA), investigational device exemption (IDE) human clinical studies are essential for validating the safety and performance of advanced drug-device combination bone grafts, providing robust data to facilitate evidence-based decisions.3

Explore our US evidence

Arnold PM, Sasso RC, Janssen ME, et al. Efficacy of i-FACTOR Bone Graft versus Autograft in Anterior Cervical Discectomy and Fusion: Results of the Prospective, Randomized, Single-blinded Food and Drug Administration Investigational Device Exemption Study. Spine (Phila Pa 1976). 2016;41(13):1075-1083.

Arnold PM, Sasso RC, Janssen ME, et al. i-Factor™ Bone Graft vs Autograft in Anterior Cervical Discectomy and Fusion: 2-Year Follow-up of the Randomized Single-Blinded Food and Drug Administration Investigational Device Exemption Study. Neurosurgery. 2018;83(3):377-384.

Arnold PM, Vaccaro AR, Sasso RC, et al. Two-Year Clinical and Radiological Outcomes in Patients With Diabetes Undergoing Single-Level Anterior Cervical Discectomy and Fusion. Global Spine J. 2021.

Thaci B, Yee R, Kim K, et al. Cost-Effectiveness of Peptide Enhanced Bone Graft i-Factor versus Use of Local Autologous Bone in Anterior Cervical Discectomy and Fusion Surgery. Clinicoecon Outcomes Res. 2021.

Arnold PM, Vaccaro AR, Sasso RC, et al. Six-Year Follow-up of a Randomized Controlled Trial of i-FACTOR Peptide-Enhanced Bone Graft Versus Local Autograft in Single-Level Anterior Cervical Discectomy and Fusion. Neurosurgery. 2023;92(4):725-733.

i-FACTOR® PMA STUDY

i-FACTOR shown to be superior to local autograft based on analysis of patient response to all four clinical endpoints from the pivotal PMA trial.4,5

 

Summary

The pinnacle of scientific evidence is the Level I PMA study. i-FACTOR Bone Graft is one of a small group of bone grafting technologies that is supported by Level I evidence. 



i-FACTOR Bone Graft was evaluated in a 319-patient, prospective, randomized, controlled, multi-center clinical trial assessing its safety and efficacy compared to standard-of-care (local autograft). Patients underwent anterior cervical discectomy and fusion (ACDF) and received either 
i-FACTOR Bone Graft or local autograft in a cortical allograft ring implanted into the target vertebral space prior to placement of the screw/plate fixation construct. The i-FACTOR 6-year follow-up IDE study results have been published in the peer-reviewed journal Neurosurgery. 


Primary Endpoints 
i-FACTOR Bone Graft met all four pre-specified primary endpoints investigated in this study by demonstrating non-inferiority to local autograft relative to fusion rate, improvement in neck disability index, and neurological success. Additionally, there was no statistical difference between i-FACTOR Bone Graft and local autograft relative to the rate of adverse events.

 
Overall Success 
An assessment of “overall success,” as judged by success in all primary endpoints, was applied to the data analysis in this investigation. The 
i-FACTOR Bone Graft group demonstrated 68.75% overall success. The local autograft control group demonstrated 56.94% overall success. The overall success was a statistically significant difference favoring the i-FACTOR Putty investigational cohort (p=0.0382). 

See how our science powers up bone repair.

Cerapedics’ bone grafts leverage a proven, distinct mechanism of action to enhance bone formation.

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References:

  1. Abjornson C, et al. Int J Spine Surg. 2018;12(6):757-771.
  2. Cerapedics. Date on File.
  3. North American Spine Society. Levels of evidence for primary research question as adopted by the North American Spine Society. 2004 Sep 28 [cited 2023 Feb 24].
  4. i-FACTOR US Instructions for Use. Cerapedics.
  5. Arnold PM, et al. Neurosurgery. 2018;83(3):377-384.