Product Classification

• Device: prosthesis, hip, semi-constrained, ceramic-on-metal articulation
• Definition: Intended as a primary joint replacement prosthesis in total hip arthroplasty.
• Physical State: metal femoral stem, ceramic femoral head, metal acetabular liner designed to fit within a metal acetaublar shell
• Technical Method: comprised of a metal liner designed to fit within a compatible acetabular shell which articulates with a compatible ceramic femoral head attached to a femoral stem as part of a primary total hip joint replacement system
• Target Area: hip joint
• Review Panel: Orthopedic
• Product Code: OVO
• Premarket Review: Office of Orthopedic Devices (OHT6); Joint Arthroplasty Devices (DHT6A)
• Submission Type: PMA
• 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

• 11-314 ISO 14242-2 Second edition 2016-09-15
  Implants for surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement
• 11-319 ISO 7206-12 First edition 2016-10-01
  Implants for surgery - Partial and total hip joint prostheses - Part 12: Deformation test method for acetabular shells
• 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
• 11-380 ASTM F2979-20
  Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses
• 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
• 11-385 ASTM F2345-21
  Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
• 11-389 ISO 7206-10 Second edition 2018-08
  Implants for surgery - Partial and total hip-joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads [Including AMENDMENT 1 (2021)]
• 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
• 11-396 ISO 7206-13 First edition 2016-07-01 [Including AMD1:2022]
  Implants for surgery - Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components [Including AMENDMENT 1 (2022)]
• 11-401 ISO 21535 Third edition 2023-07
  Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants
• 11-403 ASTM F3047M-23
  Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

Third Party Review

Not Third Party Eligible