| ASTM F2565-13 Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications |
| Recognition Date | 2016-06-27 |
| Recognition List | 043 |
| Recognition Number | 8-423 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | Materials |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
1.1 This guide covers extensively crosslinked ultra-high molecular weight polyethylene (UHMWPE) materials (fabricated forms) that are produced starting with virgin resin powders and consolidated forms meeting all the requirements of Test Method F648.
1.2 This guide does not cover fabricated forms of ultra-high molecular weight polyethylene which have received only gas plasma, ethylene oxide, or less than 40 kGy ionizing radiation treatments, that is, materials treated only by historical sterilization methods.
1.3 This guide pertains only to UHMWPE materials extensively crosslinked by gamma and electron beam sources of ionizing radiation.
1.4 The specific relationships between these mechanical properties and the in vivo performance of a fabricated form have not been determined. While trends are apparent, specific property-polymer structure and polymer-design relationships are not well understood. These mechanical tests are frequently used to evaluate the reproducibility of a fabrication procedure and are applicable for comparative studies of different materials.
1.5 The following precautionary caveat pertains only to the test method portion, Section 5, of this guide. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
| Regulation Number | Device Name | Device Class | Product Code |
| §888.3810 | Prosthesis, Wrist, Hemi-, Ulnar | Class 2 | KXE |
| §888.3800 | Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained | Class 2 | JWI |
| §888.3800 | Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | Class 2 | JWJ |
| §888.3800 | Prosthesis, Wrist, Semi-Constrained | Class 2 | KWM |
| §888.3670 | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | Class 2 | MBF |
| §888.3660 | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | Class 2 | PAO |
| §888.3660 | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Class 2 | KWS |
| §888.3660 | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | Class 2 | PKC |
| §888.3660 | Shoulder Prosthesis, Reverse Configuration | Class 2 | PHX |
| §888.3560 | Knee Arthroplasty Implantation System | Class 2 | OOG |
| §888.3560 | Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class 2 | NPJ |
| §888.3560 | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer | Class 2 | MBV |
| §888.3560 | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Class 2 | OIY |
| §888.3560 | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class 2 | JWH |
| §888.3650 | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | Class 2 | KWT |
| §888.3540 | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | Class 2 | KRR |
| §888.3535 | Prosthesis, Knee, Femorotibial, Semi-Constrained, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer | Class 2 | NJD |
| §888.3530 | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | Class 2 | HRY |
| §888.3530 | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing | Class 2 | LGE |
| §888.3520 | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Class 2 | HSX |
| §888.3510 | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Class 2 | KRO |
| §888.3500 | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite | Class 2 | KYK |
| §888.3490 | Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented | Class 2 | KTX |
| §888.3490 | Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented | Class 2 | KMB |
| §888.3390 | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Class 2 | KWY |
| §888.3358 | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | Class 2 | MBL |
| §888.3353 | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | Class 2 | OQI |
| §888.3353 | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | Class 2 | MAY |
| §888.3353 | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class 2 | LZO |
| §888.3353 | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Class 2 | MEH |
| §888.3350 | Acetabular Cup Orientation System | Class 2 | PLW |
| §888.3350 | Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | Class 2 | OQH |
| §888.3350 | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Class 2 | JDI |
| §888.3340 | Prosthesis, Hip, Semi-Constrained, Composite/Metal | Class 2 | KMC |
| §888.3310 | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | Class 2 | KWZ |
| §888.3310 | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive | Class 2 | PBI |
| §888.3150 | Prosthesis, Elbow, Constrained, Cemented | Class 2 | JDC |
| §888.3110 | Ankle Arthroplasty Implantation System | Class 2 | OYK |
| §888.3110 | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | Class 2 | HSN |
| §888.3040 | Accessory, System, External Fixator, Containing Antimicrobial Agent | Class 2 | NJA |
| §888.3040 | Appliances And Accessories, Fixation, Bone, Absorbable Single/Multiple Component | Class 2 | MRY |
| §888.3040 | Component, Traction, Invasive | Class 2 | JEC |
| §888.3040 | Fastener, Fixation, Nondegradable, Soft Tissue | Class 2 | MBI |
| §888.3040 | Laparoscopic Bone Anchor Urethropexy Instrument Kit | Class 2 | NWN |
| §888.3040 | Pin, Fixation, Resorbable, Hard Tissue | Class 2 | OVZ |
| §888.3040 | Pin, Fixation, Smooth | Class 2 | HTY |
| §888.3040 | Pin, Fixation, Smooth, Metallic | Class 2 | NDL |
| §888.3040 | Pin, Fixation, Threaded | Class 2 | JDW |
| §888.3040 | Pin, Fixation, Threaded, Metallic | Class 2 | NDM |
| §888.3040 | Sacroiliac Joint Fixation | Class 2 | OUR |
| §888.3040 | Screw, Fixation, Bone | Class 2 | HWC |
| §888.3040 | Screw, Fixation, Bone, Non-Spinal, Metallic | Class 2 | NDJ |
| §888.3040 | System, External Fixator (With Metallic Invasive Components) | Class 2 | NDK |
| There is no relevant guidance developed at this time. |