Product Classification

• Device: filler, bone void, calcium compound
• Regulation Description: Resorbable calcium salt bone void filler device.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: MQV
• Premarket Review: Office of Orthopedic Devices (OHT6); Restorative, Repair and Trauma Devices (DHT6C)
• Submission Type: 510(k)
• Regulation Number: 888.3045
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 8-427 ASTM F1185-03 (Reapproved 2014)
  Standard Specification for Composition of Hydroxylapatite for Surgical Implants
• 8-429 ASTM F2224-09 (Reapproved 2020)
  Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
• 8-457 ISO 13175-3 First edition 2012-10-01
  Implants for surgery -- Calcium phosphates -- Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes
• 8-491 ASTM F1088-18
  Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
• 8-493 ISO 13779-2 Third edition 2018-12
  Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite
• 8-516 ISO 13779-4 Second edition 2018-12
  Implants for surgery - Hydroxyapatite - Part 4: Determination of coating adhesion strength
• 8-579 ISO 13779-3 Second Edition 2018-12
  Implants for surgery -- Hydroxyapatite -- Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity [Including AMENDMENT 1 (2021)]
• 8-593 ISO 13779-6 First Edition 2015-01-15 Corrected Version 2016-09-15
  Implants for surgery - Hydroxyapatite - Part 6: Powders
• 11-197 ASTM F983-86 (Reapproved 2018)
  Standard Practice for Permanent Marking of Orthopaedic Implant Components
• 11-199 ASTM F565-04 (Reapproved 2018)
  Standard Practice for Care and Handling of Orthopedic Implants and Instruments
• 15-44 ASTM F2529-13
  Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)
• 15-54 ASTM F3207-17
  Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model

Guidance Document

• Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA

Third Party Review

Not Third Party Eligible