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Title 21
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Part 888
FEDERAL · 21 CFR
Part 888 — Orthopedic Devices
111 sections · Title 21: Food and Drugs
§ 888.1
Scope.
§ 888.3
Effective dates of requirement for premarket approval.
§ 888.5
Resurfacing technique.
§ 888.6
Degree of constraint.
§ 888.9
Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
§ 888.1100
Arthroscope.
§ 888.1240
AC-powered dynamometer.
§ 888.1250
Nonpowered dynamometer.
§ 888.1500
Goniometer.
§ 888.1520
Nonpowered goniometer.
§ 888.1600
Bone indentation device.
§ 888.3000
Bone cap.
§ 888.3010
Bone fixation cerclage.
§ 888.3015
Bone heterograft.
§ 888.3020
Intramedullary fixation rod.
§ 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.
§ 888.3041
Absorbable metallic bone fixation fastener.
§ 888.3043
Screw sleeve bone fixation device.
§ 888.3044
Resorbable implant for anterior cruciate ligament (ACL) repair.
§ 888.3045
Resorbable calcium salt bone void filler device.
§ 888.3046
Resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial.
§ 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.
§ 888.3083
Spinal spheres for use in intervertebral fusion procedures.
§ 888.3085
Intervertebral body graft containment device.
§ 888.3090
Intraoperative orthopedic strain sensor.
§ 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.
§ 888.3210
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.
§ 888.3310
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.
§ 888.3353
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.
§ 888.3390
Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
§ 888.3400
Hip joint femoral (hemi-hip) metallic resurfacing 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.
§ 888.3520
Knee joint femorotibial metal/polymer non-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.
§ 888.3600
Implantable post-surgical kinematic measurement knee device.
§ 888.3610
Medial knee implanted shock absorber.
§ 888.3630
Resorbable shoulder spacer.
§ 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.
§ 888.3695
Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or 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.
§ 888.4150
Calipers for clinical use.
§ 888.4200
Cement dispenser.
§ 888.4210
Cement mixer for clinical use.
§ 888.4220
Cement monomer vapor evacuator.
§ 888.4230
Cement ventilation tube.
§ 888.4300
Depth gauge for clinical use.
§ 888.4505
Orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation.
§ 888.4510
Manual surgical instrument for appropriate patient selection for orthopedic implant.
§ 888.4515
Orthopedic manual surgical instrumentation for use with total disc replacement devices.
§ 888.4520
Orthopedic manual surgical instrumentation for use with non-fusion spinous process spacer devices.
§ 888.4540
Orthopedic manual surgical instrument.
§ 888.4560
Intraoperative surgical angle measurement tool.
§ 888.4580
Sonic surgical instrument and accessories/attachments.
§ 888.4600
Protractor for clinical use.
§ 888.4800
Template for clinical use.
§ 888.5850
Nonpowered orthopedic traction apparatus and accessories.
§ 888.5890
Noninvasive traction component.
§ 888.5940
Cast component.
§ 888.5960
Cast removal instrument.
§ 888.5980
Manual cast application and removal instrument.