Title 21

PART 888

Part 888 - Orthopedic Devices

PART 888 - ORTHOPEDIC DEVICES Authority:21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. Source:52 FR 33702, Sept. 4, 1987, unless otherwise noted. Editorial Note:Nomenclature changes to part 888 appear at 73 FR 35341, June 23, 2008.

21:8.0.1.1.31.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.31.1.1.1SECTION 888.1
   888.1 Scope.
21:8.0.1.1.31.1.1.2SECTION 888.3
   888.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.31.1.1.3SECTION 888.5
   888.5 Resurfacing technique.
21:8.0.1.1.31.1.1.4SECTION 888.6
   888.6 Degree of constraint.
21:8.0.1.1.31.1.1.5SECTION 888.9
   888.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.31.2SUBPART B
Subpart B - Diagnostic Devices
21:8.0.1.1.31.2.1.1SECTION 888.1100
   888.1100 Arthroscope.
21:8.0.1.1.31.2.1.2SECTION 888.1240
   888.1240 AC-powered dynamometer.
21:8.0.1.1.31.2.1.3SECTION 888.1250
   888.1250 Nonpowered dynamometer.
21:8.0.1.1.31.2.1.4SECTION 888.1500
   888.1500 Goniometer.
21:8.0.1.1.31.2.1.5SECTION 888.1520
   888.1520 Nonpowered goniometer.
21:8.0.1.1.31.3SUBPART C
Subpart C [Reserved]
21:8.0.1.1.31.4SUBPART D
Subpart D - Prosthetic Devices
21:8.0.1.1.31.4.1.1SECTION 888.3000
   888.3000 Bone cap.
21:8.0.1.1.31.4.1.2SECTION 888.3010
   888.3010 Bone fixation cerclage.
21:8.0.1.1.31.4.1.3SECTION 888.3015
   888.3015 Bone heterograft.
21:8.0.1.1.31.4.1.4SECTION 888.3020
   888.3020 Intramedullary fixation rod.
21:8.0.1.1.31.4.1.5SECTION 888.3023
   888.3023 In vivo cured intramedullary fixation rod.
21:8.0.1.1.31.4.1.6SECTION 888.3025
   888.3025 Passive tendon prosthesis.
21:8.0.1.1.31.4.1.7SECTION 888.3027
   888.3027 Polymethylmethacrylate (PMMA) bone cement.
21:8.0.1.1.31.4.1.8SECTION 888.3030
   888.3030 Single/multiple component metallic bone fixation appliances and accessories.
21:8.0.1.1.31.4.1.9SECTION 888.3040
   888.3040 Smooth or threaded metallic bone fixation fastener.
21:8.0.1.1.31.4.1.10SECTION 888.3045
   888.3045 Resorbable calcium salt bone void filler device.
21:8.0.1.1.31.4.1.11SECTION 888.3050
   888.3050 Spinal interlaminal fixation orthosis.
21:8.0.1.1.31.4.1.12SECTION 888.3060
   888.3060 Spinal intervertebral body fixation orthosis.
21:8.0.1.1.31.4.1.13SECTION 888.3070
   888.3070 Thoracolumbosacral pedicle screw system.
21:8.0.1.1.31.4.1.14SECTION 888.3075
   888.3075 Posterior cervical screw system.
21:8.0.1.1.31.4.1.15SECTION 888.3080
   888.3080 Intervertebral body fusion device.
21:8.0.1.1.31.4.1.16SECTION 888.3100
   888.3100 Ankle joint metal/composite semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.17SECTION 888.3110
   888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.18SECTION 888.3120
   888.3120 Ankle joint metal/polymer non-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.19SECTION 888.3150
   888.3150 Elbow joint metal/polymer constrained cemented prosthesis.
21:8.0.1.1.31.4.1.20SECTION 888.3160
   888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.21SECTION 888.3170
   888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.
21:8.0.1.1.31.4.1.22SECTION 888.3180
   888.3180 Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.
21:8.0.1.1.31.4.1.23SECTION 888.3200
   888.3200 Finger joint metal/metal constrained uncemented prosthesis.
21:8.0.1.1.31.4.1.24SECTION 888.3210
   888.3210 Finger joint metal/metal constrained cemented prosthesis.
21:8.0.1.1.31.4.1.25SECTION 888.3220
   888.3220 Finger joint metal/polymer constrained cemented prosthesis.
21:8.0.1.1.31.4.1.26SECTION 888.3230
   888.3230 Finger joint polymer constrained prosthesis.
21:8.0.1.1.31.4.1.27SECTION 888.3300
   888.3300 Hip joint metal constrained cemented or uncemented prosthesis.
21:8.0.1.1.31.4.1.28SECTION 888.3310
   888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.
21:8.0.1.1.31.4.1.29SECTION 888.3320
   888.3320 Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.
21:8.0.1.1.31.4.1.30SECTION 888.3330
   888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
21:8.0.1.1.31.4.1.31SECTION 888.3340
   888.3340 Hip joint metal/composite semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.32SECTION 888.3350
   888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.33SECTION 888.3353
   888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
21:8.0.1.1.31.4.1.34SECTION 888.3358
   888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
21:8.0.1.1.31.4.1.35SECTION 888.3360
   888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
21:8.0.1.1.31.4.1.36SECTION 888.3370
   888.3370 Hip joint (hemi-hip) acetabular metal cemented prosthesis.
21:8.0.1.1.31.4.1.37SECTION 888.3380
   888.3380 Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis.
21:8.0.1.1.31.4.1.38SECTION 888.3390
   888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
21:8.0.1.1.31.4.1.39SECTION 888.3400
   888.3400 Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.
21:8.0.1.1.31.4.1.40SECTION 888.3410
   888.3410 Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis.
21:8.0.1.1.31.4.1.41SECTION 888.3480
   888.3480 Knee joint femorotibial metallic constrained cemented prosthesis.
21:8.0.1.1.31.4.1.42SECTION 888.3490
   888.3490 Knee joint femorotibial metal/composite non-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.43SECTION 888.3500
   888.3500 Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.44SECTION 888.3510
   888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
21:8.0.1.1.31.4.1.45SECTION 888.3520
   888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.46SECTION 888.3530
   888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.47SECTION 888.3535
   888.3535 Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis.
21:8.0.1.1.31.4.1.48SECTION 888.3540
   888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.49SECTION 888.3550
   888.3550 Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis.
21:8.0.1.1.31.4.1.50SECTION 888.3560
   888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.51SECTION 888.3565
   888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
21:8.0.1.1.31.4.1.52SECTION 888.3570
   888.3570 Knee joint femoral (hemi-knee) metallic uncemented prosthesis.
21:8.0.1.1.31.4.1.53SECTION 888.3580
   888.3580 Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis.
21:8.0.1.1.31.4.1.54SECTION 888.3590
   888.3590 Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.
21:8.0.1.1.31.4.1.55SECTION 888.3640
   888.3640 Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis.
21:8.0.1.1.31.4.1.56SECTION 888.3650
   888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.57SECTION 888.3660
   888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.58SECTION 888.3670
   888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
21:8.0.1.1.31.4.1.59SECTION 888.3680
   888.3680 Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.
21:8.0.1.1.31.4.1.60SECTION 888.3690
   888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
21:8.0.1.1.31.4.1.61SECTION 888.3720
   888.3720 Toe joint polymer constrained prosthesis.
21:8.0.1.1.31.4.1.62SECTION 888.3730
   888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.
21:8.0.1.1.31.4.1.63SECTION 888.3750
   888.3750 Wrist joint carpal lunate polymer prosthesis.
21:8.0.1.1.31.4.1.64SECTION 888.3760
   888.3760 Wrist joint carpal scaphoid polymer prosthesis.
21:8.0.1.1.31.4.1.65SECTION 888.3770
   888.3770 Wrist joint carpal trapezium polymer prosthesis.
21:8.0.1.1.31.4.1.66SECTION 888.3780
   888.3780 Wrist joint polymer constrained prosthesis.
21:8.0.1.1.31.4.1.67SECTION 888.3790
   888.3790 Wrist joint metal constrained cemented prosthesis.
21:8.0.1.1.31.4.1.68SECTION 888.3800
   888.3800 Wrist joint metal/polymer semi-constrained cemented prosthesis.
21:8.0.1.1.31.4.1.69SECTION 888.3810
   888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis.
21:8.0.1.1.31.5SUBPART E
Subpart E - Surgical Devices
21:8.0.1.1.31.5.1.1SECTION 888.4150
   888.4150 Calipers for clinical use.
21:8.0.1.1.31.5.1.2SECTION 888.4200
   888.4200 Cement dispenser.
21:8.0.1.1.31.5.1.3SECTION 888.4210
   888.4210 Cement mixer for clinical use.
21:8.0.1.1.31.5.1.4SECTION 888.4220
   888.4220 Cement monomer vapor evacuator.
21:8.0.1.1.31.5.1.5SECTION 888.4230
   888.4230 Cement ventilation tube.
21:8.0.1.1.31.5.1.6SECTION 888.4300
   888.4300 Depth gauge for clinical use.
21:8.0.1.1.31.5.1.7SECTION 888.4505
   888.4505 Orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation.
21:8.0.1.1.31.5.1.8SECTION 888.4540
   888.4540 Orthopedic manual surgical instrument.
21:8.0.1.1.31.5.1.9SECTION 888.4580
   888.4580 Sonic surgical instrument and accessories/attachments.
21:8.0.1.1.31.5.1.10SECTION 888.4600
   888.4600 Protractor for clinical use.
21:8.0.1.1.31.5.1.11SECTION 888.4800
   888.4800 Template for clinical use.
21:8.0.1.1.31.5.1.12SECTION 888.5850
   888.5850 Nonpowered orthopedic traction apparatus and accessories.
21:8.0.1.1.31.5.1.13SECTION 888.5890
   888.5890 Noninvasive traction component.
21:8.0.1.1.31.5.1.14SECTION 888.5940
   888.5940 Cast component.
21:8.0.1.1.31.5.1.15SECTION 888.5960
   888.5960 Cast removal instrument.
21:8.0.1.1.31.5.1.16SECTION 888.5980
   888.5980 Manual cast application and removal instrument.