Product Classification

• Device: plate, fixation, bone
• Regulation Description: Single/multiple component metallic bone fixation appliances and accessories.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: HRS
• Premarket Review: Restorative, Repair and Trauma Devices (DHT6C); Restorative, Repair and Trauma Devices (DHT6C)
• Submission Type: 510(k)
• Regulation Number: 888.3030
• 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

• 8-475 ASTM F2026-17
  Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
• 8-574 ASTM F2820-12(2021)e1
  Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications
• 8-577 ISO 13179-1 Second Edition 2021-09
  Implants for surgery -- Coatings on metallic surgical implants -- Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders
• 8-609 ASTM F2026-23
  Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
• 8-643 ASTM F2820-24
  Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications
• 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
• 11-325 ASTM F564-17
  Standard Specification and Test Methods for Metallic Bone Staples
• 11-327 ASTM F543-17
  Standard Specification and Test Methods for Metallic Medical Bone Screws
• 11-333 ASTM F382-17
  Standard Specification and Test Method for Metallic Bone Plates
• 11-363 ASTM F897-19
  Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
• 11-378 ASTM F2502-17
  Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
• 11-413 ASTM F543-23
  Standard Specification and Test Methods for Metallic Medical Bone Screws
• 11-414 ASTM F382-24
  Standard Specification and Test Method for Metallic Bone Plates
• 11-424 ASTM F983-24
  Standard Practice for Permanent Marking of Orthopaedic Implant Components
• 11-425 ASTM F565-21
  Standard Practice for Care and Handling of Orthopedic Implants and Instruments
• 11-430 ASTM F564-24
  Standard Specification and Test Methods for Metallic Bone Staples
• 11-438 ASTM F2502-24
  Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
• 11-439 ASTM F3437-23
  Standard Test Methods for Metallic Bone Plates Used in Small Bone Fracture Fixation

Guidance Documents

• Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway

• Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff

Third Party Review

Not Third Party Eligible