ASTM F3207-17 PDF

Full title and description

Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model — a guideline describing a single‑level rabbit posterolateral (intertransverse) lumbar spine fusion model used to evaluate the ability of bone grafts, bone void fillers, and related materials to produce posterolateral spinal fusion in vivo.

Designation: ASTM F3207‑17. Published by ASTM International; intended for preclinical, comparative evaluation of materials and devices for posterolateral spinal fusion research and regulatory submissions.

Abstract

This guide documents recommended animal implantation methods, sample sizes, radiographic/histologic/biomechanical assessments, and end‑point criteria for the rabbit lumbar intertransverse (posterolateral) spinal fusion model. It is intended to standardize nonclinical testing so that results for bone grafts, bone void fillers, and related spinal fusion therapies can be compared against each other and against autograft controls in a reproducible manner.

General information

• Status: Published (active guide).
• Publication date: 31 May 2017 (designation F3207‑17; published 2017).
• Publisher: ASTM International (ASTM).
• ICS / categories: 11.040.40 (Implants for surgery, prosthetics and orthotics); 11.100.99 (Other standards related to laboratory medicine).
• Edition / version: F3207‑17 (2017 edition).
• Number of pages: 16 pages.

Scope

The guide covers the single‑level rabbit posterolateral (intertransverse) lumbar fusion model: animal selection and care, surgical approach and graft placement, recommended control groups (commonly iliac crest autograft), evaluation time points, radiographic imaging, micro‑CT/histology preparation and scoring, biomechanical testing options, data reporting, and basic statistical considerations for comparing fusion outcomes. The model is principally intended for comparative, preclinical efficacy assessment of bone grafts and bone void fillers for posterolateral spinal fusion.

Key topics and requirements

• Animal model description: single‑level rabbit lumbar posterolateral/intertransverse fusion.
• Recommended surgical technique and implantation procedures (graft placement and fixation of graft material between transverse processes).
• Control groups and reference materials (eg, iliac crest autograft) for comparative assessment.
• Outcome measures: radiographic and micro‑CT evaluation, histology/histomorphometry, and optional biomechanical testing.
• Suggested observation time points, sample sizes, and reporting recommendations to support regulatory submissions.
• Guidance on humane animal care, ethical considerations, and compliance with applicable animal welfare regulations.

Typical use and users

Preclinical researchers in biomaterials, orthopaedic and spine device developers, contract research organizations (CROs), and regulatory affairs professionals use this guide to design and report rabbit posterolateral fusion studies that evaluate efficacy of bone grafts, bone void fillers, scaffolds, or adjunctive biologic therapies prior to clinical translation or as part of regulatory submissions.

Related standards

Standards and guides commonly referenced alongside F3207 include other ASTM guides for preclinical bone model evaluation (for example, guides addressing critical‑size segmental bone defects and scaffold characterization), as well as test methods for imaging, histomorphometry, and device biocompatibility. F3207‑17 is also listed among standards recognized by regulatory authorities for tissue‑engineering and implant evaluation.

Keywords

rabbit model; lumbar; intertransverse; posterolateral fusion; spinal fusion; bone graft; bone void filler; preclinical; in vivo; histology; radiography; micro‑CT; biomechanical testing.

FAQ

Q: What is this standard?

A: ASTM F3207‑17 is a Standard Guide describing methods and outcome measures for conducting and reporting single‑level rabbit lumbar intertransverse (posterolateral) spinal fusion studies used to evaluate the efficacy of bone grafts and related materials in vivo.

Q: What does it cover?

A: It covers the animal model, recommended surgical implantation technique, control/comparator selection (commonly iliac crest autograft), imaging and histologic endpoints, optional biomechanical testing, recommended reporting and statistical considerations, and animal welfare practices appropriate to this preclinical model.

Q: Who typically uses it?

A: Biomaterials researchers, orthopaedic and spine device developers, CROs performing GLP/non‑GLP animal studies, and regulatory teams preparing preclinical packages for submission to regulatory agencies.

Q: Is it current or superseded?

A: The document is the 2017 edition (F3207‑17) and is published/active. It is listed in regulatory recognition records (example: FDA recognized entry date June 7, 2018). A revision work item to update F3207‑17 (WK94594) was opened by the ASTM F04 committee (work initiated April 16, 2025), indicating revision activity; users should confirm the current status with ASTM or their standards subscription before relying on the standard for regulatory submissions.

Q: Is it part of a series?

A: F3207‑17 is part of ASTM Committee F04’s body of standards addressing medical and surgical materials and devices; it is commonly used together with other ASTM preclinical guidance documents for bone and tissue‑engineered products.

Q: What are the key keywords?

A: Rabbit model; posterolateral fusion; intertransverse; spinal fusion; bone graft; bone void filler; in vivo evaluation; histology; radiography; micro‑CT; biomechanical testing.