Product Classification

• Device: prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer
• Regulation Description: Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis.
• Definition: Intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as uni-compartmental osteoarthritis; inflammatory arthritis; traumatic arthritis; varus, valgus or flexion deformities; and revision surgery.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: NJD
• Premarket Review: Office of Orthopedic Devices (OHT6); Joint Arthroplasty Devices (DHT6A)
• Submission Type: 510(k)
• Regulation Number: 888.3535
• 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

• 8-195 ASTM F2024-10 (Reapproved 2016)
  Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
• 8-368 ASTM F2625-10 (Reapproved 2016)
  Standard Test Method for Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry
• 8-378 ASTM D792-13
  Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
• 8-379 ISO 11542-2 First edition 1998-11-15
  Plastics - Ultra-high-molecular-weight polyethyelene (PE-UHMW) moulding and extrusion materials - Part 2: Preparation of test specimens and determination of properties [Including: Technical Corrigendum 1 (2007)]
• 8-403 ASTM D638-14
  Standard Test Method for Tensile Properties of Plastics
• 8-404 ASTM E647-15
  Standard Test Method for Measurement of Fatigue Crack Growth Rates
• 8-427 ASTM F1185-03 (Reapproved 2014)
  Standard Specification for Composition of Hydroxylapatite for Surgical Implants
• 8-493 ISO 13779-2 Third edition 2018-12
  Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite
• 8-495 ISO 5834-3 Second edition 2019-02
  Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 3: Accelerated ageing methods
• 8-496 ISO 5834-4 Second edition 2019-02
  Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 4: Oxidation index measurement method
• 8-497 ISO 5834-5 Second edition 2019-02
  Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 5: Morphology assessment method
• 8-501 ISO 5834-1 Fourth edition 2019-02
  Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1: Powder form
• 8-514 ISO 5834-2 Fifth edition 2019-02
  Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms
• 8-516 ISO 13779-4 Second edition 2018-12
  Implants for surgery - Hydroxyapatite - Part 4: Determination of coating adhesion strength
• 8-569 ASTM F648-21
  Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
• 8-572 ASTM F2565-21
  Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
• 8-573 ASTM F2695-12(2020)
  Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms 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
• 8-579 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
• 11-232 ISO 7207-1 Third edition 2007-02-01
  Implants for surgery - Components for partial and total knee joint prostheses - Part 1: Classification, definitions and designation of dimensions
• 11-341 ASTM F3140-17
  Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements
• 11-366 ASTM F2381-19
  Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy
• 11-374 ISO 7207-2 Second edition 2011-07-01
  Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials [Including AMENDMENT 1 (2016) and AMENDMENT 2 (2020)]
• 11-377 ASTM F2083-21
  Standard Specification for Knee Replacement Prosthesis
• 11-395 ASTM F1814-22
  Standard Guide for Evaluating Modular Hip and Knee Joint Components
• 11-400 ISO 21536 Third edition 2023-07
  Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants
• 11-406 ASTM F3141-23
  Standard Guide for Total Knee Replacement Loading Profiles
• 11-407 ASTM F3140-23
  Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements
• 11-408 ASTM F2777-23
  Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion

Third Party Review

Not Third Party Eligible