Product Classification

• Device: hip, semi-constrained, cemented, metal/polymer + additive, cemented
• Regulation Description: Hip joint metal/polymer semi-constrained cemented prosthesis.
• Definition: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Cemented and uncemented use.
• Physical State: May include: Acetabular Shell Acetabular Liner Femoral Head Femoral Stem Femoral Neck Instrumentation
• Technical Method: This device is intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene containing an additive such as a-tocopherol and is limited to those prostheses intended for use with bone cement.
• Target Area: hip
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: OQH
• Premarket Review: Joint Arthroplasty Devices (DHT6A); Joint Arthroplasty Devices (DHT6A)
• Submission Type: 510(k)
• Regulation Number: 888.3350
• 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

• 8-378 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
• 8-495 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
• 8-572 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
• 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
• 11-272 ASTM F1714-96 (Reapproved 2018)
  Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
• 11-277 ISO 7206-6 Second edition 2013-11-15
  Implants for surgery - Partial and total hip joint prostheses - Part 6: Determination of endurance properties of head and neck region of stemmed femoral components
• 11-299 ASTM F2068-15
  Standard Specification for Femoral Prostheses - Metallic Implants
• 11-306 ASTM F1814-15
  Standard Guide for Evaluating Modular Hip and Knee Joint Components
• 11-307 ASTM F2385-15 (Reapproved 2019)
  Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs
• 11-312 ISO 7206-4 Third edition 2010-06-15
  Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components [Including AMENDMENT 1 (2016)]
• 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
• 11-320 ISO 7206-13 First edition 2016-07-01
  Implants for surgery - Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components
• 11-337 ISO 16087 First edition 2013-10-01
  Implants for surgery - Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants
• 11-338 ISO 11491 First edition 2017-07
  Implants for surgery - Determination of impact resistance of ceramic femoral heads for hip joint prostheses
• 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) ]
• 11-342 ASTM F732-17
  Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
• 11-344 ASTM F2580-18
  Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis
• 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
• 11-366 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
• 11-371 ASTM F2009-20
  Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
• 11-372 ASTM F2996-20
  Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems
• 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
• 11-385 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

Third Party Review

Not Third Party Eligible