21 CFR Part 888 — Orthopedic Devices
Subpart A — General Provisions
Subpart B — Diagnostic Devices
Subpart D — Prosthetic Devices
- § 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.
- § 888.3043— Screw sleeve bone fixation device.
- § 888.3044— Resorbable implant for anterior cruciate ligament (ACL) repair.
- § 888.3045— Resorbable calcium salt bone void filler device.
- § 888.3050— 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.
- § 888.3630— 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.
- § 888.3720— 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.
Subpart E — Surgical Devices
- § 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.
- § 888.4515— 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.
- § 888.4580— 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.