Prosthetic Devices | Midpage

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Code of Federal Regulations

Subpart D

Prosthetic Devices

888.3000Bone cap.888.3010Bone fixation cerclage.888.3015Bone heterograft.888.3020Intramedullary fixation rod.888.3023In vivo cured intramedullary fixation rod.888.3025Passive tendon prosthesis.888.3027Polymethylmethacrylate (PMMA) bone cement.888.3030Single/multiple component metallic bone fixation appliances and accessories.888.3040Smooth or threaded metallic bone fixation fastener.888.3041Absorbable metallic bone fixation fastener.888.3043Screw sleeve bone fixation device.888.3044Resorbable implant for anterior cruciate ligament (ACL) repair.888.3045Resorbable calcium salt bone void filler device.888.3046Resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial.888.3050Spinal interlaminal fixation orthosis.888.3060Spinal intervertebral body fixation orthosis.888.3070Thoracolumbosacral pedicle screw system.888.3075Posterior cervical screw system.888.3080Intervertebral body fusion device.888.3083Spinal spheres for use in intervertebral fusion procedures.888.3085Intervertebral body graft containment device.888.3090Intraoperative orthopedic strain sensor.888.3100Ankle joint metal/composite semi-constrained cemented prosthesis.888.3110Ankle joint metal/polymer semi-constrained cemented prosthesis.888.3120Ankle joint metal/polymer non-constrained cemented prosthesis.888.3150Elbow joint metal/polymer constrained cemented prosthesis.888.3160Elbow joint metal/polymer semi-constrained cemented prosthesis.888.3170Elbow joint radial (hemi-elbow) polymer prosthesis.888.3180Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.888.3200Finger joint metal/metal constrained uncemented prosthesis.888.3210Finger joint metal/metal constrained cemented prosthesis.888.3220Finger joint metal/polymer constrained cemented prosthesis.888.3230Finger joint polymer constrained prosthesis.888.3300Hip joint metal constrained cemented or uncemented prosthesis.888.3310Hip joint metal/polymer constrained cemented or uncemented prosthesis.888.3320Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.888.3330Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.888.3340Hip joint metal/composite semi-constrained cemented prosthesis.888.3350Hip joint metal/polymer semi-constrained cemented prosthesis.888.3353Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.888.3358Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.888.3360Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.888.3370Hip joint (hemi-hip) acetabular metal cemented prosthesis.888.3380Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis.888.3390Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.888.3400Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.888.3410Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis.888.3480Knee joint femorotibial metallic constrained cemented prosthesis.888.3490Knee joint femorotibial metal/composite non-constrained cemented prosthesis.888.3500Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.888.3510Knee joint femorotibial metal/polymer constrained cemented prosthesis.888.3520Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.888.3530Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.888.3535Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis.888.3540Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.888.3550Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis.888.3560Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.888.3565Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.888.3570Knee joint femoral (hemi-knee) metallic uncemented prosthesis.888.3580Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis.888.3590Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.888.3600Implantable post-surgical kinematic measurement knee device.888.3610Medial knee implanted shock absorber.888.3630Resorbable shoulder spacer.888.3640Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis.888.3650Shoulder joint metal/polymer non-constrained cemented prosthesis.888.3660Shoulder joint metal/polymer semi-constrained cemented prosthesis.888.3670Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.888.3680Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.888.3690Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.888.3695Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis.888.3720Toe joint polymer constrained prosthesis.888.3730Toe joint phalangeal (hemi-toe) polymer prosthesis.888.3750Wrist joint carpal lunate polymer prosthesis.888.3760Wrist joint carpal scaphoid polymer prosthesis.888.3770Wrist joint carpal trapezium polymer prosthesis.888.3780Wrist joint polymer constrained prosthesis.888.3790Wrist joint metal constrained cemented prosthesis.888.3800Wrist joint metal/polymer semi-constrained cemented prosthesis.888.3810Wrist joint ulnar (hemi-wrist) polymer prosthesis.