Product Classification

• Device: prosthesis, hip, pelvifemoral resurfacing, metal/polymer
• Regulation Description: Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis.
• Definition: Pma to be filed by 1/3/05 (69 fr 59134 (10/4/04)) for any hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis that was in commercial distribution before may 28, 1976, or that has, on or before january 3, 2005, been found to be substantially equivalent to a hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis that was in commercial distribution before may 28, 1976. Any other hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis must have an approved pma or a declared completed pdp in effect before being placed in commercial distribution.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: KXB
• Premarket Review: Office of Orthopedic Devices (OHT6); Joint Arthroplasty Devices (DHT6A)
• Submission Type: PMA
• Regulation Number: 888.3410
• Device Class: 3
• 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

• 8-226 ASTM F603-12 (Reapproved 2020)
  Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
• 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
• 11-314 ISO 14242-2 Second edition 2016-09-15
  Implants for surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement
• 11-337 ISO 16087 First edition 2013-10-01
  Implants for surgery - Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants
• 11-339 ISO 7206-2 Third edition 2011-04-01 AMENDMENT 1 2016-09-15
  Implants for surgery - Partial and total hip joint prostheses - Part 2: Articulating surfaces made of metallic, ceramic and plastics materials [Including AMENDMENT1 (2016) ]
• 11-340 ASTM F3018-17
  Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
• 11-342 ASTM F732-17
  Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
• 11-349 ISO 14242-3 First edition 2009-03-15
  Implants for surgery - Wear of total hip-joint prostheses - Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2019)]
• 11-352 ISO 14242-1 Third edition 2014-10-15
  Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)]
• 11-358 ISO 14242-4 First edition 2018-05
  Implants for surgery - Wear of total hip-joint prostheses - Part 4: Testing hip prostheses under variations in component positioning which results in direct edge loading
• 11-376 ASTM F2033-20
  Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials
• 11-381 ASTM F2582-20
  Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components
• 11-382 ASTM F3090-20
  Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement
• 11-383 ASTM F3143-20
  Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Replacement Bearings under Standard Conditions Using a Reciprocal Friction Simulator
• 11-384 ASTM F3446-20
  Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Implants Using an Anatomical Motion Hip Simulator
• 11-394 ASTM F1820-22
  Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices
• 11-395 ASTM F1814-22
  Standard Guide for Evaluating Modular Hip and Knee Joint Components
• 11-401 ISO 21535 Third edition 2023-07
  Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants

Guidance Document

• Non-clinical Information for Femoral Stem Prostheses

Third Party Review

Not Third Party Eligible