Title 21, Part 888 — Orthopedic Devices

Scope.

Effective dates of requirement for premarket approval.

Resurfacing technique.

Degree of constraint.

Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Arthroscope.

AC-powered dynamometer.

Nonpowered dynamometer.

Goniometer.

Nonpowered goniometer.

Bone indentation device.

Bone cap.

Bone fixation cerclage.

Bone heterograft.

Intramedullary fixation rod.

In vivo cured intramedullary fixation rod.

Passive tendon prosthesis.

Polymethylmethacrylate (PMMA) bone cement.

Single/multiple component metallic bone fixation appliances and accessories.

Smooth or threaded metallic bone fixation fastener.

Screw sleeve bone fixation device.

Resorbable implant for anterior cruciate ligament (ACL) repair.

Resorbable calcium salt bone void filler device.

Spinal interlaminal fixation orthosis.

Spinal intervertebral body fixation orthosis.

Thoracolumbosacral pedicle screw system.

Posterior cervical screw system.

Intervertebral body fusion device.

Spinal spheres for use in intervertebral fusion procedures.

Intervertebral body graft containment device.

Intraoperative orthopedic strain sensor.

Ankle joint metal/composite semi-constrained cemented prosthesis.

Ankle joint metal/polymer semi-constrained cemented prosthesis.

Ankle joint metal/polymer non-constrained cemented prosthesis.

Elbow joint metal/polymer constrained cemented prosthesis.

Elbow joint metal/polymer semi-constrained cemented prosthesis.

Elbow joint radial (hemi-elbow) polymer prosthesis.

Elbow joint humeral (hemi-elbow) metallic uncemented prosthesis.

Finger joint metal/metal constrained uncemented prosthesis.

Finger joint metal/metal constrained cemented prosthesis.

Finger joint metal/polymer constrained cemented prosthesis.

Finger joint polymer constrained prosthesis.

Hip joint metal constrained cemented or uncemented prosthesis.

Hip joint metal/polymer constrained cemented or uncemented prosthesis.

Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.

Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

Hip joint metal/composite semi-constrained cemented prosthesis.

Hip joint metal/polymer semi-constrained cemented prosthesis.

Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

Hip joint (hemi-hip) acetabular metal cemented prosthesis.

Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis.

Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.

Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.

Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis.

Knee joint femorotibial metallic constrained cemented prosthesis.

Knee joint femorotibial metal/composite non-constrained cemented prosthesis.

Knee joint femorotibial metal/composite semi-constrained cemented prosthesis.

Knee joint femorotibial metal/polymer constrained cemented prosthesis.

Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.

Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.

Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis.

Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.

Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis.

Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

Knee joint femoral (hemi-knee) metallic uncemented prosthesis.

Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis.

Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.

Implantable post-surgical kinematic measurement knee device.

Resorbable shoulder spacer.

Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis.

Shoulder joint metal/polymer non-constrained cemented prosthesis.

Shoulder joint metal/polymer semi-constrained cemented prosthesis.

Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.

Shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis.

Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

Toe joint polymer constrained prosthesis.

Toe joint phalangeal (hemi-toe) polymer prosthesis.

Wrist joint carpal lunate polymer prosthesis.

Wrist joint carpal scaphoid polymer prosthesis.

Wrist joint carpal trapezium polymer prosthesis.

Wrist joint polymer constrained prosthesis.

Wrist joint metal constrained cemented prosthesis.

Wrist joint metal/polymer semi-constrained cemented prosthesis.

Wrist joint ulnar (hemi-wrist) polymer prosthesis.

Calipers for clinical use.

Cement dispenser.

Cement mixer for clinical use.

Cement monomer vapor evacuator.

Cement ventilation tube.

Depth gauge for clinical use.

Orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation.

Orthopedic manual surgical instrumentation for use with total disc replacement devices.

Orthopedic manual surgical instrumentation for use with non-fusion spinous process spacer devices.

Orthopedic manual surgical instrument.

Sonic surgical instrument and accessories/attachments.

Protractor for clinical use.

Template for clinical use.

Nonpowered orthopedic traction apparatus and accessories.

Noninvasive traction component.

Cast component.

Cast removal instrument.

Manual cast application and removal instrument.