21 CFR Subpart D
Prosthetic Devices
June 25, 2020
§
888.3020
Intramedullary fixation rod
§
888.3000
Bone cap
§
888.3010
Bone fixation cerclage
§
888.3015
Bone heterograft
§
888.3023
In vivo cured intramedullary fixation rod
§
888.3025
Passive tendon prosthesis
§
888.3027
Polymethylmethacrylate (PMMA) bone cement
§
888.3030
Single/multiple component metallic bone fixation appliances and accessories
§
888.3040
Smooth or threaded metallic bone fixation fastener
§
888.3045
Resorbable calcium salt bone void filler device
§
888.3050
Spinal interlaminal fixation orthosis
§
888.3060
Spinal intervertebral body fixation orthosis
§
888.3070
Thoracolumbosacral pedicle screw system
§
888.3075
Posterior cervical screw system
§
888.3080
Intervertebral body fusion device
§
888.3100
Ankle joint metal/composite semi-constrained cemented prosthesis
§
888.3110
Ankle joint metal/polymer semi-constrained cemented prosthesis
§
888.3120
Ankle joint metal/polymer non-constrained cemented prosthesis
§
888.3150
Elbow joint metal/polymer constrained cemented prosthesis
§
888.3160
Elbow joint metal/polymer semi-constrained cemented prosthesis
§
888.3170
Elbow joint radial (hemi-elbow) polymer prosthesis
§
888.3180
Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis
§
888.3200
Finger joint metal/metal constrained uncemented prosthesis
§
888.3390
Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis
§
888.3210
Finger joint metal/metal constrained cemented prosthesis
§
888.3220
Finger joint metal/polymer constrained cemented prosthesis
§
888.3230
Finger joint polymer constrained prosthesis
§
888.3300
Hip joint metal constrained cemented or uncemented prosthesis
§
888.3400
Hip joint femoral (hemi-hip) metallic resurfacing prosthesis
§
888.3310
Hip joint metal/polymer constrained cemented or uncemented prosthesis
§
888.3320
Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis
§
888.3330
Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis
§
888.3340
Hip joint metal/composite semi-constrained cemented prosthesis
§
888.3350
Hip joint metal/polymer semi-constrained cemented prosthesis
§
888.3520
Knee joint femorotibial metal/polymer non-constrained cemented prosthesis
§
888.3353
Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
§
888.3358
Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis
§
888.3360
Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis
§
888.3370
Hip joint (hemi-hip) acetabular metal cemented prosthesis
§
888.3380
Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis
§
888.3410
Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis
§
888.3480
Knee joint femorotibial metallic constrained cemented prosthesis
§
888.3490
Knee joint femorotibial metal/composite non-constrained cemented prosthesis
§
888.3500
Knee joint femorotibial metal/composite semi-constrained cemented prosthesis
§
888.3510
Knee joint femorotibial metal/polymer constrained cemented prosthesis
§
888.3530
Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis
§
888.3535
Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis
§
888.3540
Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis
§
888.3550
Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis
§
888.3560
Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis
§
888.3565
Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis
§
888.3570
Knee joint femoral (hemi-knee) metallic uncemented prosthesis
§
888.3580
Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis
§
888.3590
Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis
§
888.3640
Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis
§
888.3650
Shoulder joint metal/polymer non-constrained cemented prosthesis
§
888.3660
Shoulder joint metal/polymer semi-constrained cemented prosthesis
§
888.3670
Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis
§
888.3680
Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis
§
888.3690
Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis
§
888.3720
Toe joint polymer constrained prosthesis
§
888.3730
Toe joint phalangeal (hemi-toe) polymer prosthesis
§
888.3750
Wrist joint carpal lunate polymer prosthesis
§
888.3760
Wrist joint carpal scaphoid polymer prosthesis
§
888.3770
Wrist joint carpal trapezium polymer prosthesis
§
888.3780
Wrist joint polymer constrained prosthesis
§
888.3790
Wrist joint metal constrained cemented prosthesis
§
888.3800
Wrist joint metal/polymer semi-constrained cemented prosthesis
§
888.3810
Wrist joint ulnar (hemi-wrist) polymer prosthesis