Product Classification

• Device: prosthesis, hip, semi-constrained, metal/metal, resurfacing
• Definition: Prosthesis, hip, semi-constrained, metal/metal, resurfacing device relieves hip pain and improves hip function by replacing the parts of the hip that have been severely damaged by degenerative joint diseases. This device is indicated for patients with degenerative joint diseases including osteoarthritis, rheumatoid arthritis, traumatic arthritis, dysplasia, or avascular necrosis and for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip replacement due to an increased possibility of requiring future hip joint revision.
• Physical State: The femoral resurfacing component and acetabular components are made of metal. These surfaces rub against each other (the bearing couple) and are made from highly-polished metal. This type of bearing couple is called a metal-on-metal bearing couple.
• Technical Method: Prosthesis, hip, semi-constrained, metal/metal, resurfacing device has two parts: a socket in the shape of a shallow cup (acetabular component), and a cap in the form of a ball head (femoral resurfacing component). The cup replaces the damaged surface of the hip socket (acetabulum). The cap covers or resurfaces the ball-shaped bone at the top of the thigh (femoral head), and the cap has a small stem that is inserted into the top of the thighbone. The cap moves within the cup.
• Target Area: The device is to replace the hip joint.
• Review Panel: Orthopedic
• Product Code: NXT
• 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
• 11-337 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
• 11-349 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
• 11-379 ASTM F2978-20
  Standards Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging
• 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
• 11-394 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
• 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