| ASTM F2695-12 Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications |
| Recognition Date | 2016-06-27 |
| Recognition List | 043 |
| Recognition Number | 8-424 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | Materials |
| FDA Tech | Peter Allen FDA/OMPT/CDRH/ODE/DOD/JFDB1/ 301-796-6402 peter.allen@fda.hhs.gov |
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 specification covers ultra-high molecular weight polyethylene (UHMWPE) powder blended with alpha-tocopherol (vitamin E) intended for use in surgical implants.
1.2 The requirements of this specification apply to alpha-tocopherol-containing UHMWPE in two forms. One is virgin polymer powder blended with alpha-tocopherol prior to consolidation (Section 4). The second is any form fabricated from this blended, alpha-tocopherol-containing powder from which a finished product is subsequently produced (Section 5). This specification does not apply to finished or semi-finished products that are doped with vitamin E after consolidation.
1.3 Aside from blending with alpha-tocopherol, the provisions of Specifications F648 and D4020 apply. Special requirements detailed in this specification are added to describe powders containing alpha-tocopherol that will be used in surgical implants. This specification addresses material characteristics and does not apply to the packaged and sterilized finished implant. This specification also does not apply to UHMWPE materials extensively crosslinked by gamma and electron beam sources of ionizing radiation.
1.4 The following precautionary caveat pertains only to the fabricated forms portion, Section 5, of this specification. 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 |
| §888.3650 | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | Class 2 | KWT |
| §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 |
| §888.3540 | 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 |
| §888.3353 | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | Class 2 | OQI |
| §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 |
| §888.4210 | Mixer, Cement, For Clinical Use | Class 1 | JDZ |
| §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. |