Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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038
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Date of Entry 01/27/2015
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FR Recognition Number
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8-385
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Standard | |
ASTM F648-14 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants |
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Scope/Abstract1.1 This specification covers ultra-high molecular weight polyethylene powder (UHMWPE) and fabricated forms intended for use in surgical implants.
1.2 The requirements of this specification apply to UHMWPE in two forms. One is virgin polymer powder (Section 4). The second is any form fabricated from this powder from which a finished product is subsequently produced (Section 5). This specification addresses material characteristics and does not apply to the packaged and sterilized finished implant.
1.3 The requirements of this specification do not apply to UHMWPE virgin powder or fabricated forms intentionally crosslinked or blended with other additives, for example, antioxidants.
1.4 The biological response to polyethylene in soft tissue and bone has been well characterized by a history of clinical use (1, 2, 3)2 and by laboratory studies (4, 5, 6).
1.5 The values stated in SI units are to be regarded as standard.
1.6 The following precautionary caveat pertains only to the test method portion, Section 7, 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. |
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Extent of Recognition
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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. |
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Transition Period
FDA recognition of ASTM F648-14 [Rec# 8-385] will be superseded by recognition of ASTM F648-21 [Rec# 8-569]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-385] until December 18th, 2022. After this transition period, declarations of conformity to [Rec# 8-385] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§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 |
§888.3540 |
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer |
Class 2 |
KRR |
§888.3500 |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite |
Class 2 |
KYK |
§888.3150 |
Prosthesis, Elbow, Constrained, Cemented |
Class 2 |
JDC |
§888.3040 |
Pin, Fixation, Smooth |
Class 2 |
HTY |
§888.3040 |
Screw, Fixation, Bone |
Class 2 |
HWC |
§888.3040 |
Pin, Fixation, Threaded |
Class 2 |
JDW |
§888.3040 |
Component, Traction, Invasive |
Class 2 |
JEC |
§888.3040 |
Fastener, Fixation, Nondegradable, Soft Tissue |
Class 2 |
MBI |
§888.3040 |
Prosthesis, Subtalar, Plug, Polymer |
Class 2 |
MJW |
§888.3040 |
Appliances And Accessories, Fixation, Bone, Absorbable Single/Multiple Component |
Class 2 |
MRY |
§888.3040 |
Screw, Fixation, Bone, Non-Spinal, Metallic |
Class 2 |
NDJ |
§888.3040 |
System, External Fixator (With Metallic Invasive Components) |
Class 2 |
NDK |
§888.3040 |
Pin, Fixation, Smooth, Metallic |
Class 2 |
NDL |
§888.3040 |
Pin, Fixation, Threaded, Metallic |
Class 2 |
NDM |
§888.3040 |
Accessory, System, External Fixator, Containing Antimicrobial Agent |
Class 2 |
NJA |
§888.3040 |
Laparoscopic Bone Anchor Urethropexy Instrument Kit |
Class 2 |
NWN |
§888.3040 |
Sacroiliac Joint Fixation |
Class 2 |
OUR |
§888.3040 |
Pin, Fixation, Resorbable, Hard Tissue |
Class 2 |
OVZ |
§888.3040 |
Transtibial Anterior Cruciate Ligament Kit |
Class 2 |
PPQ |
§888.3110 |
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer |
Class 2 |
HSN |
§888.3110 |
Ankle Arthroplasty Implantation System |
Class 2 |
OYK |
§888.3340 |
Prosthesis, Hip, Semi-Constrained, Composite/Metal |
Class 2 |
KMC |
§888.3353 |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
Class 2 |
LZO |
§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, 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 |
§888.3358 |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous |
Class 2 |
MBL |
§888.3390 |
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented |
Class 2 |
KWY |
§888.3490 |
Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented |
Class 2 |
KMB |
§888.3490 |
Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented |
Class 2 |
KTX |
§888.3510 |
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer |
Class 2 |
KRO |
§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 |
§888.3560 |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
Class 2 |
JWH |
§888.3560 |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer |
Class 2 |
MBV |
§888.3560 |
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
Class 2 |
NPJ |
§888.3560 |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive |
Class 2 |
OIY |
§888.3560 |
Knee Arthroplasty Implantation System |
Class 2 |
OOG |
§888.3650 |
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented |
Class 2 |
KWT |
§888.3660 |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
Class 2 |
KWS |
§888.3660 |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented |
Class 2 |
PAO |
§888.3660 |
Shoulder Prosthesis, Reverse Configuration |
Class 2 |
PHX |
§888.3660 |
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained |
Class 2 |
PKC |
§888.3660 |
Shoulder Arthroplasty Implantation System |
Class 2 |
QHE |
§888.3660 |
Total Shoulder Arthroplasty System |
Class 2 |
QHQ |
§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 |
§888.3350 |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
Class 2 |
JDI |
§888.3350 |
Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented |
Class 2 |
OQH |
§888.3350 |
Acetabular Cup Orientation System |
Class 2 |
PLW |
§888.3520 |
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer |
Class 2 |
HSX |
§888.3670 |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented |
Class 2 |
MBF |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |
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