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Device

prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

Regulation Description

Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

Regulation Medical Specialty

Orthopedic

Review Panel

Orthopedic

Product Code

LPH

Premarket Review

Office of Orthopedic Devices (OHT6)
Joint Arthroplasty Devices (DHT6A)

Submission Type

510(k)

Regulation Number

888.3358

Device Class

Total Product Life Cycle (TPLC)

TPLC Product Code Report

GMP Exempt?

Summary Malfunction
Reporting

Eligible

Implanted Device?

Yes

Life-Sustain/Support Device?

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)]
8-380 ASTM F1160-14 (Reapproved 2017)e1
Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
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
8-429 ASTM F2224-09 (Reapproved 2020)
Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
8-493 ISO 13779-2 Third edition 2018-12
Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite
8-516 ISO 13779-4 Second edition 2018-12
Implants for surgery - Hydroxyapatite - Part 4: Determination of coating adhesion strength
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)]
8-585 ASTM F1377-21
Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538)
8-593 ISO 13779-6 First Edition 2015-01-15 Corrected Version 2016-09-15
Implants for surgery - Hydroxyapatite - Part 6: Powders
11-183 ASTM F1875-98 (Reapproved 2022)
Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface
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
11-307 ASTM F2385-15 (Reapproved 2024)
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
11-337 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) ]
11-342 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
11-416 ASTM F2996-24
Standard Test Method for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems
11-417 ASTM F3090-24
Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement and Performance Requirements
11-420 ASTM F2580-24
Standard Test Method for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prostheses

Guidance Document

Non-clinical Information for Femoral Stem Prostheses

Third Party Review

Not Third Party Eligible

Product Classification

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