Part 888 — Orthopedic Devices
Current through Sep 8, 2026
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.
Sections
- § 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.