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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 043 Date of Recognition 06/27/2016 
FR Recognition Number 8-424
Standard
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
Scope/Abstract
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.

Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)
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
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 Peter Allen
  FDA/OMPT/CDRH/ODE/DOD/JFDB1/
  301-796-6402
  peter.allen@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Materials
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