Evidence map›Paper›PMID 41987831›Full record

ReviewJOR spine2026

From Concept to Clinic: Pre-Clinical Testing and Regulatory Considerations in Spine Implant Development.

Amit Benady, Jerrin Thadathil Varghese, Ryan David Quarrington, Morsi Khashan, B Gangadhara Prusty, Ashish Diwan

Abstract readReview
In one paragraph

Review in JOR spine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Amit BenadyDepartment of Orthopedic Surgery Tel Aviv Medical Center Affiliated to Tel Aviv University Tel Aviv Israel.ORCID https://orcid.org/0000-0003-3348-5000
Jerrin Thadathil VargheseSchool of Mechanical and Manufacturing Engineering, UNSW Sydney New South Wales Australia.ORCID https://orcid.org/0000-0002-9704-7395
Ryan David QuarringtonCenter for Orthopedics and Trauma Research Adelaide Medical School, The University of Adelaide Adelaide Australia.ORCID https://orcid.org/0000-0002-0633-2482
Morsi KhashanDepartment of Orthopedic Surgery Tel Aviv Medical Center Affiliated to Tel Aviv University Tel Aviv Israel.
B Gangadhara PrustySchool of Mechanical and Manufacturing Engineering, UNSW Sydney New South Wales Australia.
Ashish DiwanSpine Labs, St George and Sutherland Clinical School University of New South Wales Sydney New South Wales Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Spinal implant development demands integration of biomechanical rigor with regulatory compliance. For surgeons, researchers, and biomedical engineers engaged in translational research, understanding the regulatory pathway, from the Methods: This paper reviews the major regulatory frameworks governing spinal implants, including the Discussion: Key elements of the regulatory process include design controls and documentation (DHF/technical file), Conclusion: Understanding the biomechanical foundations of the development process is crucial for the safe and successful translation of spine implants into clinical use. Surgeons and implant designers should engage early, understand the critical steps, and advocate for rigorous validation aligned with regulatory expectations to deliver safer and more effective implants to clinical practice.

Indexed as

biomechanicschemistry, manufacturing, and controls (CMC)Conformité Européenne (CE)design history file (DHF)European Union medical device regulation (EU MDR)finite element analysis (FEA)premarket approvalregulatory pathwayspine implant

Identifiers

PMID41987831
PMCPMC13077288

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.