Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
|
057
|
Date of Entry 12/20/2021
|
FR Recognition Number
|
8-573
|
Standard | |
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 |
|
Scope/Abstract1.1 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. |
|
Extent of Recognition
|
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. |
|
Transition Period
FDA recognition of ASTM F2695-12 [Rec# 8-424] will be superseded by recognition of ASTM F2695-12 (2020) [Rec# 8-573]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-424] until December 18th, 2022. After this transition period, declarations of conformity to [Rec# 8-424] will not be accepted. |
|
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§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 |
§888.3110 |
Ankle Arthroplasty Implantation System |
Class 2 |
OYK |
§888.3110 |
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer |
Class 2 |
HSN |
§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 |
§888.3340 |
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 |
§888.3340 |
Prosthesis, Hip, Semi-Constrained, Composite/Metal |
Class 2 |
KMC |
§888.4210 |
Mixer, Cement, For Clinical Use |
Class 1 |
JDZ |
§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 |
§888.3353 |
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 |
§888.3353 |
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented |
Class 2 |
OQI |
§888.3390 |
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented |
Class 2 |
KWY |
§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 |
§888.3500 |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite |
Class 2 |
KYK |
§888.3510 |
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer |
Class 2 |
KRO |
§888.3520 |
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer |
Class 2 |
HSX |
§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 |
§888.3535 |
Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer |
Class 2 |
NJD |
§888.3540 |
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer |
Class 2 |
KRR |
§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 |
§888.3660 |
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 |
§888.3670 |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented |
Class 2 |
MBF |
§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 |
§888.3810 |
Prosthesis, Wrist, Hemi-, Ulnar |
Class 2 |
KXE |
§888.4210 |
Mixer, Cement, For Clinical Use |
Class 1 |
JDZ |
|
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and Food and Drug Administration Staff: Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices, Issued April 2019 |
|
FDA Technical Contact
|
Standards Development Organization
|
FDA Specialty Task Group (STG)
|
|
*These are provided as examples and others may be applicable. |
|
|