Recognized Consensus Standards

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

050

Date of Entry 09/17/2018

FR Recognition Number

11-197

Standard

ASTM F983-86 (Reapproved 2018)
Standard Practice for Permanent Marking of Orthopaedic Implant Components

Scope/Abstract

1.1 It is common practice for orthopaedic implant manufacturers to apply permanent identification to implant components. In this regard, Practice F86 describes recommended locations and methods of marking for metallic implants.
1.2 The purpose of this practice is to (1) recommend that orthopaedic implants be permanently marked, and (2) recommend practical amounts of information that should be included in the marking. It is recognized, however, that marking is not practical in some cases (see 4.1).

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
§888.3015	Bone, Heterograft	Class 3	NVC
§888.3045	Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation	Class 2	OIS
§888.3045	Filler, Bone Void, Calcium Compound	Class 2	MQV
§888.3045	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Class 2	MBP
§888.3050	Accessories, Fixation, Spinal Interlaminal	Class 2	LYP
§888.3050	Appliance, Fixation, Spinal Interlaminal	Class 2	KWP
§888.3050	Orthosis, Spine, Plate, Laminoplasty, Metal	Class 2	NQW
§888.3060	Appliance, Fixation, Spinal Intervertebral Body	Class 2	KWQ
§888.3060	Implant, Fixation Device, Spinal	Class 2	JDN
§888.3060	Resorbable Spinal Intervertebral Body Fixation Orthosis - Mesh	Class 2	OJM
§888.3060	Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate	Class 2	OJB
§888.3060	Spinal Vertebral Body Replacement Device	Class 2	MQP
§888.3080	Intervertebral Fusion Device With Bone Graft, Cervical	Class 2	ODP
§888.3080	Intervertebral Fusion Device With Bone Graft, Lumbar	Class 2	MAX
§888.3210	Prosthesis, Finger, Constrained, Metal, Cemented	Class 3	LBC
§888.3230	Prosthesis, Finger, Constrained, Polymer	Class 2	KYJ
§888.3230	Prosthesis, Finger, Polymer	Class 2	KWF
§888.3320	Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)	Class 3	JDL
§888.3320	Spacer, Cement	Class 3	LTO
§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
§888.3400	Prosthesis, Hip, Femoral, Resurfacing	Class 2	KXA
§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
§888.3580	Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented	Class 2	HTG
§888.3310	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Class 2	KWZ
§888.3027	Bone Cement	Class 2	LOD
§888.3027	Bone Cement, Antibiotic	Class 2	MBB
§888.3027	Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty	Class 2	OBL
§888.3027	Cement, Bone, Vertebroplasty	Class 2	NDN
§888.3027	Cement, Bone, Vertebroplasty, Pre-Formed, Modular	Class 2	OBM
§888.3027	Vertebroplasty Compound, Calcium Based	Class 2	NUD
§888.3070	Orthosis, Spinal Pedicle Fixation	Class 2	MNI
§888.3070	Orthosis, Spondylolisthesis Spinal Fixation	Class 2	MNH
§888.3070	Posterior Metal/Polymer Spinal System, Fusion	Class 2	NQP
§888.3070	Thoracolumbosacral Pedicle Screw System	Class 2	NKB
§888.3170	Prosthesis, Elbow, Hemi-, Radial, Polymer	Class 2	KWI
§888.3200	Prosthesis, Finger, Constrained, Metal, Uncemented	Class 3	KWE
§888.3220	Prosthesis, Finger, Constrained, Metal/Polymer	Class 3	KWG
§888.3330	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Class 3	KWA
§888.3340	Prosthesis, Hip, Semi-Constrained, Composite/Metal	Class 2	KMC
§888.3358	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Class 2	OQG
§888.3358	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Class 2	LPH
§888.3358	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Class 2	MBL
§888.3360	Prosthesis, Hip, Femoral Component, Cemented, Metal	Class 2	JDG
§888.3360	Prosthesis, Hip, Hemi-, Femoral, Metal	Class 2	KWL
§888.3360	Prosthesis, Hip, Hemi-, Femoral, Metal Ball	Class 2	LZY
§888.3360	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Class 2	LWJ
§888.3360	Prosthesis, Upper Femoral	Class 2	JDD
§888.3410	Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer	Class 3	KXB
§888.3410	Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented	Class 3	OCG
§888.3480	Metal Cemented Constrained Femorotibial Knee Prosthesis	Class 3	KRN
§888.3480	Prosthesis, Knee, Hinged (Metal-Metal)	Class 3	HRZ
§888.3565	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Class 2	MBH
§888.3570	Prosthesis, Knee, Hemi-, Femoral (Uncemented)	Class 3	KRS
§888.3640	Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented	Class 3	KWR
§888.3650	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Class 2	KWT
§888.3660	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Class 2	KWS
§888.3680	Metallic Cemented Glenoid Hemi-Shoulder Prosthesis	Class 3	KYM
§888.3690	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Class 2	HSD
§888.3720	Prosthesis, Toe, Constrained, Polymer	Class 2	KWH
§888.3760	Prosthesis, Wrist, Carpal Scaphoid	Class 2	KWO
§888.3020	Rod, Fixation, Intramedullary And Accessories	Class 2	HSB
§888.3020	Rod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible	Class 2	NDE
§888.3030	Anchor, Suture, Bone Fixation, Metallic	Class 2	NOV
§888.3030	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Class 2	KTT
§888.3030	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite	Class 2	LXT
§888.3030	Appliance, Fixation, Nail/Blade/Plate Combination, Single Component	Class 2	KTW
§888.3030	Appliance, Nail/Blade/Plate Combination, Single Component	Class 2	KWK
§888.3030	Condylar Plate Fixation Implant	Class 2	JDP
§888.3030	Device, Fixation, Proximal Femoral, Implant	Class 2	JDO
§888.3030	Electronic Depth Gauge	Class 2	OOL
§888.3030	Fastener, Fixation, Biodegradable, Soft Tissue	Class 2	MAI
§888.3030	Fixation Accessory	Class 2	LYT
§888.3030	Nail, Fixation, Bone	Class 2	JDS
§888.3030	Nail, Fixation, Bone, Metallic	Class 2	NDH
§888.3030	Plate, Bone, Growth Control, Pediatric, Epiphysiodesis	Class 2	OBT
§888.3030	Plate, Fixation, Bone	Class 2	HRS
§888.3030	Plate, Fixation, Bone, Non-Spinal, Metallic	Class 2	NDF
§888.3030	Staple, Absorbable	Class 2	MNU
§888.3030	Staple, Fixation, Bone	Class 2	JDR
§888.3030	Staple, Fixation, Bone, Metallic	Class 2	NDI
§888.3030	Washer, Bolt Nut	Class 2	HTN
§888.3030	Washer, Bolt, Nut, Non-Spinal, Metallic	Class 2	NDG
§888.3160	Prosthesis, Elbow, Semi-Constrained, Cemented	Class 2	JDB
§888.3300	Prosthesis, Hip, Constrained, Metal	Class 3	KXD
§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
§888.3390	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Class 2	KWY
§888.3510	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Class 2	KRO
§888.3540	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Class 2	KRR
§888.3750	Prosthesis, Wrist, Carpal Lunate	Class 2	KWN
§888.3770	Prosthesis, Wrist, Carpal Trapezium	Class 2	KYI
§888.3790	Prosthesis, Wrist, Constrained, Metal	Class 3	KYN
§888.3110	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Class 2	HSN
§888.3120	Prosthesis, Ankle, Cemented, Non-Constrained	Class 3	KXC
§888.3180	Prosthesis, Elbow, Hemi-, Humeral, Metal	Class 3	KWJ
§888.3500	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite	Class 2	KYK
§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
§888.3550	Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal	Class 3	KRP
§888.3550	Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer	Class 2	KRQ
§888.3670	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Class 2	MBF
§888.3730	Prosthesis, Toe, Hemi-, Phalangeal	Class 2	KWD
§888.3780	Prosthesis, Wrist, Constrained, Polymer	Class 2	KIG
§888.3810	Prosthesis, Wrist, Hemi-, Ulnar	Class 2	KXE
§888.3000	Cap, Bone	Class 1	JDT
§888.3025	Prosthesis, Tendon, Passive	Class 2	HXA
§888.3040	Accessory, System, External Fixator, Containing Antimicrobial Agent	Class 2	NJA
§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, 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	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
§888.3100	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite	Class 2	KMD
§888.3150	Prosthesis, Elbow, Constrained, Cemented	Class 2	JDC
§888.3370	Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal	Class 3	KWB
§888.3520	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Class 2	HSX
§888.3535	Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer	Class 2	NJD
§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
§888.3590	Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)	Class 2	HSH
§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
§882.4650	Needle, Neurosurgical Suture	Class 1	HAS
§888.3010	Cerclage, Fixation	Class 2	JDQ
§888.3010	Cerclage, Fixation, Metallic	Class 2	NDD

Relevant FDA Guidance and/or Supportive Publications*

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.

FDA Technical Contacts

Jonathan Peck

FDA/OC/CDRH/OPEQ/OHTVI/DHTVIB/

301-796-5650

jonathan.peck@fda.hhs.gov

Christopher Ferreira

FDA/OC/CDRH/OPEQ/OHTVI/DHTVIC/

301-796-9350

christopher.ferreira@fda.hhs.gov

Standards Development Organization

ASTM

ASTM International