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Pediatric Plates and Screws used for Bone Fixation: An Engineering Reference Dataset

 

Catalog of Regulatory Science Tools to Help Assess New Medical Devices 

 

This regulatory science tool (RST) serves as a reference dataset summarizing the engineering characteristics for orthopedic bone fixation devices (plates and screws) in pediatric patients.

 

Technical Description

The regulatory science tool contains a summary of engineering characteristics including dimensions, materials, and geometries for plates and screws used to provide fixation and stabilization of various bones. The engineering characteristics are based on aggregated and de-identified summary data from previously cleared devices with pediatric indications (neonates, infants, children, adolescents). [1, 2]

Intended Purpose

This RST offers an engineering reference dataset of sizes, materials, and geometries that may assist orthopedic device manufacturers in developing bone fixation plates and screws (HRS, HWC product codes) for use in pediatric patients.

Testing

Engineering characteristics of metallic, non-absorbable bone fixation plates and screws (HRS and/or HWC product codes) were collected from submissions cleared in FDA’s 510(k) database. [3] To maintain confidentiality, all information collected from the 510(k) database was aggregated and de-identified.  The device characteristics were compared for consistency against anthropometric data of pediatric anatomy from published literature. [4, 5] The engineering characteristics in this tool align with multiple standards for bone fixation devices; specifically, standards that outline material parameters and geometries. [6-12]

Limitations

This RST is limited to metallic, non-absorbable bone fixation plates and screws under the HRS, HWC product codes only.  Additional engineering characteristics may be necessary or appropriate for pediatric patients. The tool may be revised as new information becomes available.

Supporting Documentation

The regulatory science tool’s User Manual with the engineering characteristics of bone fixation plates and screws for pediatric patients.

References

  1. Code of Federal Regulations [21 CFR 814.3(s)]
  2. Premarket Assessment of Pediatric Medical Devices: Guidance for Industry and Food and Drug Administration Staff. March 14, 2014.  https://www.fda.gov/media/73510/download.
  3. Food and Drug Administration. 510(k) Premarket Notification. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm
  4. Pietak, A., Ma, S., Beck, C. W., & Stringer, M. D. (2013). Fundamental ratios and logarithmic periodicity in human limb bones. J Anat, 222(5), 526-537. https://doi.org/10.1111/joa.12041
  5. McDowell, M. A., Fryar, C. D., Ogden, C. L., & Flegal, K. M. (2008). Anthropometric reference data for children and adults: United States, 2003-2006. Natl Health Stat Report(10), 1-48. https://www.ncbi.nlm.nih.gov/pubmed/25585443
  6. ASTM Standard F136-13(2021)e1, “Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)”  ASTM International, West Conshohocken, PA, 2019, DOI: 10.1520/F0136-13R21E01, www.astm.org
  7. ASTM Standard F138-19, “Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)”  ASTM International, West Conshohocken, PA, 2019, DOI: 10.1520/F0138-19, www.astm.org
  8. ASTM Standard F139-19, “Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)”  ASTM International, West Conshohocken, PA, 2019, DOI: 10.1520/F0139-19, www.astm.org
  9. ASTM Standard F382-17, “Standard Specification and Test Method for Metallic Bone Plates”  ASTM International, West Conshohocken, PA, 2017, DOI: 10.1520/F0382-17, www.astm.org
  10. ASTM Standard F384-17, “Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices” ASTM International, West Conshohocken, PA, 2017, DOI: 10.1520/F0384-17, www.astm.org
  11. ASTM Standard F543-17, “Standard Specification and Test Methods for Metallic Medical Bone Screws” ASTM International, West Conshohocken, PA, 2017, DOI: 10.1520/F0543-17, www.astm.org
  12. ASTM Standard F2229-21, “Standard Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29108)” ASTM International, West Conshohocken, PA, 2017, DOI: 10.1520/F0543-17, www.astm.org

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