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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 11-197: ASTM F983-86 (Reapproved 2013), standard practice for permanent marking of orthopaedic implant components. (Orthopaedics)

Date of Standard: 1986. 
Address of Standards Development Organization:
 ASTM International (ASTM)
  100 Barr Harbor Drive
  West Conshohocken, PA 19428-2959
 
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Metallic Implants
Processes Affected:
510(k), PMA, IDE, PDP, Design Controls
Type of Standard:
 Test Methods, Horizontal, International
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§888.3000 Cap, Bone Class 1 JDT
§888.3015 Bone, Heterograft Class 3 NVC
§888.3020 Rod, Fixation, Intramedullary And Accessories Class 2 HSB
§888.3020 Rod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible Class 2 NDE
§888.3025 Prosthesis, Tendon, Passive Class 2 HXA
§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
§888.3030 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
§888.3040 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 Kit, Laparoscopic, Bone Anchor, Urethropexy 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
§888.3045 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
§888.3350 Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented Class 2 OQH
§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
§888.3070 Orthosis, Spinal Pedicle Fixation Class 2 MNI
§888.3070 Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease Class 3 NKB
§888.3070 Orthosis, Spondylolisthesis Spinal Fixation Class 2 MNH
§888.3070 Posterior Metal/Polymer Spinal System, Fusion Class 2 NQP
§888.3080 Intervertebral Fusion Device With Bone Graft, Cervical Class 2 ODP
§888.3080 Intervertebral Fusion Device With Bone Graft, Lumbar Class 2 MAX
§888.3100 Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite Class 2 KMD
§888.3110 Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Class 2 HSN
§888.3120 Prosthesis, Ankle, Cemented, Non-Constrained Class 3 KXC
§888.3150 Prosthesis, Elbow, Constrained, Cemented Class 2 JDC
§888.3160 Prosthesis, Elbow, Semi-Constrained, Cemented Class 2 JDB
§888.3170 Prosthesis, Elbow, Hemi-, Radial, Polymer Class 2 KWI
§888.3180 Prosthesis, Elbow, Hemi-, Humeral, Metal Class 3 KWJ
§888.3200 Prosthesis, Finger, Constrained, Metal, Uncemented Class 3 KWE
§888.3210 Prosthesis, Finger, Constrained, Metal, Cemented Class 3 LBC
§888.3220 Prosthesis, Finger, Constrained, Metal/Polymer Class 3 KWG
§888.3230 Prosthesis, Finger, Constrained, Polymer Class 2 KYJ
§888.3230 Prosthesis, Finger, Polymer Class 2 KWF
§888.3300 Prosthesis, Hip, Constrained, Metal Class 3 KXD
§888.3010 Cerclage, Fixation Class 2 JDQ
§888.3010 Cerclage, Fixation, Metallic Class 2 NDD
§888.3310 Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Class 2 KWZ
§888.3320 Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) Class 3 JDL
§888.3320 Spacer, Cement Class 3 LTO
§888.3330 Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) Class 3 KWA
§888.3340 Prosthesis, Hip, Semi-Constrained, Composite/Metal Class 2 KMC
§888.3350 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, Calicum-Phosphate Class 2 MEH
§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
§888.3060 Spinal Vertebral Body Replacement Device Class 2 MQP
§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
§888.3560 Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Class 2 NPJ
§888.3370 Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal Class 3 KWB
§888.3390 Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Class 2 KWY
§888.3400 Prosthesis, Hip, Femoral, Resurfacing Class 2 KXA
§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
§888.3490 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, Semi-Constrained, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer Class 2 NJD
§888.3540 Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Class 2 KRR
§888.3550 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
§888.3560 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
§888.3565 Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Class 2 MBH
§882.4650 Needle, Neurosurgical Suture Class 1 HAS
§888.3570 Prosthesis, Knee, Hemi-, Femoral (Uncemented) Class 3 KRS
§888.3580 Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented Class 2 HTG
§888.3590 Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented) Class 2 HSH
§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
§888.3670 Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Class 2 MBF
§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
§888.3730 Prosthesis, Toe, Hemi-, Phalangeal Class 2 KWD
§888.3750 Prosthesis, Wrist, Carpal Lunate Class 2 KWN
§888.3760 Prosthesis, Wrist, Carpal Scaphoid Class 2 KWO
§888.3770 Prosthesis, Wrist, Carpal Trapezium Class 2 KYI
§888.3780 Prosthesis, Wrist, Constrained, Polymer Class 2 KIG
§888.3790 Prosthesis, Wrist, Constrained, Metal Class 3 KYN
§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
No product code information listed for §888.3XXX, Implantable metallic components
FDA Technical Contact:
 Ronald Jean
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1414
  Silver Spring MD 20993
  301/796-5650
  email: ronald.jean@fda.hhs.gov
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